5-methoxy-n,n-dimethyltryptamine (5-meo-DMT) for treating depression

Abstract

To provide compositions for use in treating a patient suffering from a mental disorder in particular major depressive disorder, persistent depressive disorder, anxiety disorder, posttraumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder and psychoactive substance abuse.SOLUTION: The present invention provides 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient who is diagnosed with major depressive disorder by a licensed professional in accordance with accepted medical practice.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention provides a therapeutically effective amount of 5-methoxy-N,N-dimethyltrimethylsilyl 1,2-diaminobenzyl 2,4-trimethylsilyl 1,2-diaminobenzyl 2,4-trimethylsilyl 1,2-diaminobenzyl 2,4-diaminobenz ... psychiatric disorders, particularly major depressive disorder, including administering 5-MeO-DMT , persistent depressive disorder, anxiety disorder, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, The present invention is directed to improved methods for the treatment of eating disorders and psychoactive substance abuse. [Background technology]

[0002] Hallucinogens are chemicals, some naturally occurring and some synthetic, that produce auditory and visual disturbances after ingestion. changes in the brain and their ability to induce sensory distortions in humans, including mood and cognitive distortions The term hallucinogen is a set of psychoactive molecules with different modes of action. Some psychiatric disorders are in principle responsive to treatment with psychoactive molecules. It has been suggested that there is. Summary of the Invention

[0003] The present invention provides a therapeutically effective amount of 5-methoxy-N,N-dimethyltrimethylsilyl 1,2-diaminobenzyl 2,4-trimethylsilyl 1,2-diaminobenzyl 2,4-trimethylsilyl 1,2-diaminobenzyl 2,4-diaminobenz ... psychiatric disorders, particularly major depressive disorder, including administering 5-MeO-DMT , persistent depressive disorder, anxiety disorder, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, 5-Methoxy-N,N-dimethylformamide for use in the treatment of eating disorders and psychoactive substance abuse The present invention relates to tyrtryptamine (5-MeO-DMT) or a pharma- ceutically acceptable salt thereof.

[0004] The present invention is particularly directed to the treatment of major depressive disorder, as determined by a qualified medical professional in accordance with accepted medical practice. 5-Methoxy-N,N-dimethyltriptyline for use in the treatment of patients diagnosed with The present invention relates to 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. According to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) published by the American Psychiatric Association, For example, a patient may be diagnosed with depression with a Montgomery-Asberg Depression Rating Scale score of 20 or higher. (MADRS) score of 17 or higher on the Hamilton Depression Rating Scale (HAM-D) The patient may suffer from moderate or severe major depressive disorder as indicated by a 10-point scale score. Participants were assessed for depression by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 35 or greater. or severe as indicated by a Hamilton Depression Scale (HAM-D) score of 25 or greater The patient may be diagnosed with treatment-resistant major depressive disorder. It may be cut off.

[0005] Additionally, the patient may be suffering from suicidal ideation, particularly suicidal ideation accompanied by the intent to carry it out. , and may even be at imminent risk of suicide.

[0006] 5-MeO-DMT or a pharma- ceutical acceptable salt thereof provides patients with a psychedelic experience that is similar to that of a psychedelic drug. The dose or dosage regimen may be administered in a dose range of about 4 mg to about 20 mg. A molar amount of 5-MeO-DMT or an equimolar amount of a pharma- ceutically acceptable salt may be administered. Further, the dosage is about 6 mg, about 12 mg, or about 18 mg of 5-MeO-D It may be MT or an equimolar amount of a pharma- ceutically acceptable salt thereof.

[0007] The 5-MeO-DMT or pharma- ceutically acceptable salt is administered in a first dosage amount in the first administration. may be administered in doses, followed by 0 to 6 subsequent doses, each subsequent dose being administered until the patient reaches the optimal Use higher dosages than previous doses unless a psychedelic experience is desired.

[0008] Further, 5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg. The second dose is administered approximately 8 hours after the initial dose, unless the patient has already experienced a peak psychedelic experience. The dose may be increased to about 10 mg to about 14 mg, after which the patient experiences a peak psychedelic experience. Unless previously administered, the dose may be increased to about 14 mg to about 20 mg for the third dose. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt may be administered in place of 5-MeO-DMT. The first dose of 5-MeO-DMT may be about 6 mg, and the first dose of 5-MeO-DMT may be about 6 mg. The second dose of 5-MeO-DMT may be about 12 mg, and the third dose of 5-MeO-DMT may be about 1 8 mg, or an equimolar amount of a pharma- ceutically acceptable A salt thereof may also be administered.

[0009] The interval between two doses may be 1 hour or more and 24 hours or less, and is preferably about 2 to 4 hours. It may be time.

[0010] The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30). Each of the four subscales (mystical, positive mood, transcendence of time and space, and ineffability) can be identified by the achievement of at least 60% of the highest possible score in The maximum possible score for the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire is at least Identified by achievement of 60% or preferably at least 75 Supreme Psychedelics This is identified by the achievement of a total score on the Experience Questionnaire (PPEQ).

[0011] The 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is preferably administered by inhalation. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is, in particular, (a) a pharma- ceutically acceptable (b) 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DM T) or a pharma- ceutically acceptable salt thereof. The aerosol may have an aerosol particle quality of about 0.5 mg / L to about 12.5 mg / L. The aerosol has a mass density of a) 5-MeO-DMT or b) 5-MeO-DMT formulated on a solid support. a) exposing a thin layer of a pharma- ceutically acceptable salt thereof to thermal energy; and b) forming voids in the thin layer. The aerosol may be generated by passing air through the device to create aerosol particles. Preferably, it contains 5-MeO-DMT in the form of a free base.

[0012] When administered by inhalation, the 5-MeO-DMT administered to the patient or a pharma- ceutical The dosage of salt to be administered is preferably inhaled in one breath.

[0013] The above-indicated treatment with 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is This response is measured by the Clinical Global Impression-Improvement (CGI-I) score or the patient response. Patients were given a score of at least "marked improvement" on the Patient Global Impression-Improvement (PGI-I) scale. The improvement may be determined by the core, preferably by the administration of 5-MeO-DMT or pharmacological This occurs within about 2 hours after the last dose of an acceptable salt thereof.

[0014] At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response determined by the above is preferably determined by the administration of 5-MeO-DMT or a pharma- ceutically acceptable At least 6 days, more preferably at least 14 days, especially at least It lasts for at least 28 days.

[0015] Clinical response was also significantly improved by improving MAD scores compared with the respective scores before administration of 5-MeO-DMT. This may be determined by at least a 50% improvement in RS or HAM-D score. The response is preferably observed after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. It occurs within about 2 hours. In addition, a MADRS score of 10 or less or a HAM- Remission of depressive symptoms as determined by the D score is preferably achieved with 5-MeO-DMT or This occurs within about 2 hours after the last administration of a pharma- ceutically acceptable salt thereof.

[0016] At least an increase in MADRS or HAM-D scores compared with the respective scores before treatment A clinical response, as determined by at least a 50% improvement, is preferably achieved with 5-MeO-DMT or at least 6 days after the last administration of a physiologically acceptable salt thereof, and more preferably at least The symptoms persist for up to 14 days, and especially for at least 28 days.

[0017] Preferably, the MADRS or HAM-D score is compared to the respective score before treatment. A clinical response, as determined by at least 75% improvement in clinical outcomes, was determined using 5-MeO-DMT or 7 days, more preferably even 14 days, especially after the last administration of a pharma- ceutically acceptable salt thereof. Further, on day 28. More preferably, the patient is 7 days, preferably further 14 days, in particular further 2 days, after the last administration of a commercially acceptable salt thereof. On day 8, the patient was assessed as having a MADRS score of 10 or less or a HAM-D score of 7 or less. The patient is in remission from depressive symptoms.

[0018] Further aspects of the present invention are defined below in the embodiments section. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Hallucinogens include tetrahydrocannabinol, a cannabinoid that acts on cannabinoid receptors. Hydrocannabinol (THC), trace amine associated receptor 1 (TAAR1) and vesicular moiety 3,4-Methylenediamine is an entactogen that acts on the vascular amine transporter 2 (VMAT2) Methamphetamine (MDMA, "Ecstasy") and N-methyl-D-aspartate One example is ketamine, a dissociative anesthetic that acts on the NMDA receptor antagonist. Can be obtained.

[0020] Further groups of hallucinogens include lysergic acid diethylamide (LSD), psilocybin and N , 5-hydroxytryptamine (5-HT) such as N-dimethyltryptamine (DMT) Receptors or serotonin receptors (7 families, 5-HT1 to 5-HT7, and 14 types) The latter group of compounds binds to serotonin receptors (subtypes are described). These drugs are often referred to as "classic hallucinogens" or "psychedelics," which are drugs that produce euphoric, sensations, trances, transcending time and space, spiritual experiences, the collapse of self-boundaries or even near-death experiences. This article highlights their primary ability to induce qualitative alterations in the state of consciousness in humans, including sedation, coma, or other effects such as overstimulation are only minimal.

[0021] Chemically, serotonergic psychedelics are classified as phenylalkylamines or indomethacin. The indoleamine class is either an ergoline or a tryptamine. The latter is divided into two subsets of

[0022] [ka]

[0023] It is derived from tryptamine, which has the formula:

[0024] Various serotonergic psychedelics act on various serotonin receptors, particularly 5-HT It has different binding affinities and activation abilities for 1A, 5-HT2A, and 5-HT2C. Their activity also correlates with other targets, such as monoamine transporters and trace amine-associated receptors. may be modulated by interactions between

[0025] A tryptamer contained in the South American shrub Psychotria Viridis DMT, a tryptamine found in over 200 mushroom species, or scyllium, a tryptamine found in over 200 mushroom species. Cibin, or phenylalanine, found in the citrus cactus of the southwestern United States and northern Mexico Naturally occurring psychedelic drugs, such as the alkylamine mescaline, are used by indigenous cultures. It has been used for centuries in ritual, socio-cultural and religious sacramental contexts. The use of naturally occurring psychedelics in these settings has been shown to have unspecified "therapeutic" effects. " Although these have been attributed to their potential therapeutic use in established disease entities, More scientific investigation of the drug was only explored after the discovery of the synthetic ergoline LSD in 1943. .

[0026] These early clinical experiences from the 1950s and 1960s were still relatively methodologically tenuous. There is limited but promising evidence, for example, that patients given LSD in conjunction with psychotherapy show improved mental Alcoholism treatment programs show higher abstinence or improvement rates than patients who received physical therapy alone Jensen SE, QJ Stud Alcohol. 1962; 23:315-20, or as an adjunct to psychotherapy. By administering LSD as a treatment, more than 90% of patients showed "marked improvement" or "improvement" Observations of patients with personality trait confusion or anxiety who had a positive outcome (MacLean JR t al., QJ Stud Alcohol. 1961; 22:34-45), or about a third of patients treated with LSD. The treatment of patients with terminal cancer improved to various degrees in two areas (Pahnke WN et al., Ps ychedelic drugs. Proceedings of a Hahnemann Medical College and Hospital Symposia um. Editors: Richard E. Hicks, Paul Jay Fink, Van Buren O. Hammett. Grune & Stra tton, New York / London 1969, pp.33-42).

[0027] With the emergence of knowledge about the serotonin system and its role in brain function, researchers The molecular activities of an increasing number of psychedelic drugs are being identified. It is somewhat unclear how these translate into their observed treatment effects in psychiatric disorders. Two main concepts were proposed: the first was named "psychotherapy" This suggests that low doses of psychedelics may help relax psychological defense mechanisms, This, in combination with psychotherapy, allows for deep introspective insight and trauma recovery, followed by The emphasis was on the cathartic potential of psychopaths. The basic mechanism considered in the psychiatric approach is the activation and deepening of the co-psychotherapeutic process. This required multiple drugs and therapy sessions. The term was coined “psychedelic therapy,” which refers to the use of high, single-dose psychedelics. The study emphasized the ability of the drug to induce a "peak psychedelic experience" in the subject. It is characterized primarily by a loss of sense of time and space and a breakdown in ego boundaries, which is often In the case of Thus, the fundamental mechanisms considered in the psychedelic approach are psychological An intuitive perception of unity and harmony, followed by increased self-improvement and joy in life and resulting in a unique, overwhelming experience accompanied by a sense of inner peace.

[0028] Scientific research into the use of psychedelic drugs to treat mental disorders began in the 1960s. Although the drug was first developed, recreational use of these substances spread rapidly and psychedelics soon became popular in the medical field. It was described in the media as an extremely dangerous drug of abuse. It was perceived as a danger to social order. This led to the passage of the Controlled Substances Act of 1970, which prohibited LSD and other psychiatric Dextroiac drugs are among the most controlled drugs, including those that have no medical use and are considered to have a high potential for abuse. For the next 30 years, psychiatric Very little progress has been made regarding the possible therapeutic use of dermic drugs.

[0029] Only in recent years has there been a resurgence of interest in the field of psychedelic therapy. and / or mood symptoms in 51 cancer patients. A randomized, double-blind, crossover study comparing a single dose of Sebo with a single dose of a higher dose At the high dose, clinical indicators and self-ratings of depression, anxiety or mood disturbance after 5 weeks of treatment There was a significant reduction in the measures and an increase in the quality of life measures, and these effects continued for 6 months. (Griffiths RR et al., J Psychopharmacol. 2016; 30(12):1181- 1197) A single dose of silobicin versus placebo in 29 cancer patients with anxiety and depression. In another randomized, double-blind, crossover study of niacin as a comparator, The drug provided immediate and substantial relief of anxiety and depression, and reduced cancer-related demoralization. Depression and hopelessness were reduced, and quality of life was improved, with sustained benefits at 6.5 months follow-up. The results were consistent with those reported in the literature (Ross S et al., J Psychopharmacol. 2016; 30(12):1165-1180). Further positive experiences with the drug were seen in patients with treatment-resistant depression (defined in detail in the study). An open-label single-dose study of low and high doses of sirovicin administered 7 days apart in 20 patients. This occurred in the Luarm feasibility study, which included 1 and 5 weeks after treatment. Depressive symptoms were significantly reduced from baseline (Carhart-Harris RL et al., Lancet Psy chiatry. 2016; 3(7):619-27; Carhart-Harris RL et al., Psychopharmacology (Berl). 2018; 235(2):399-408). Psilocybin has been shown to be effective in treating obsessive-compulsive disorder (Moreno FA et al., J Clin Psyc hiatry. 2006; 67(11):1735-40) and alcoholism (Bogenschutz MP et al., JP psychopharmacol. 2015; 29(3):289-99) and tobacco dependence (Johnson MW et al., J Psy chopharmacol. 2014; 28(11):983-92; Johnson MW et al., Am J Drug Alcohol Abuse. 2 017; 43(1):55-60). 1. Patients with anxiety associated with life-threatening illnesses regarding the penetrating psychedelic drug LSD A double-blind, randomized, active, placebo-controlled pilot study in two patients showed that 2-month follow-up Follow-up studies have reported significant effects on anxiety indicators (Gasser P et al., JN erv Ment Dis. 2014; 202(7):513-20). In addition, monoamine oxidase (MAO) inhibitors Contains the psychoactive drug DMT in combination with harmine, harmaline and tetrahydroharmine Ayahuasca, a shamanic tea with a shamanic effect, has been shown to be effective in treating treatment-resistant major depression (defined in detail in the study). A randomized, double-blind, placebo-controlled, single-dose session study in 35 patients with Controlled trials have shown rapid antidepressant effects compared with placebo (Palhano-Fontes F et al. al., bioRxiv 103531. 2017; doi: https: / / doi.org / 10.1101 / 103531).

[0030] The inventors believe that these results suggest that administration of certain serotonergic psychedelics may It is believed that these findings suggest that this may be a promising approach for the treatment of various psychiatric disorders. However, efficacy and safety studies that meet regulatory standards have not been conducted to date, and Psychedelic drugs have not been approved by any regulatory agency. Available data indicate that none of the drugs tested achieved remission in all patients. and that some patients may lose response after achieving remission, and that the drugs tested It is clear that there are still problems with side effects associated with Currently proposed acute psychedelic effects following oral administration of psychedelic drugs last for several hours. This is an inconvenience for patients and providers and places significant limitations on their practical use. For example, the treatment resistance published by Carhart-Harris et al. In a study of psilocybin in depression (defined in detail in the study), of 20 patients Nine patients responded at 5 weeks, but by 6 months, 3 had relapsed again, with symptoms including anxiety, headaches, and nausea. Psychological side effects are frequently reported, and the acute psychedelic effects of psilocybin last for approximately 5-6 hours. Based on the duration of Ca, at least 7 hours of monitoring were required after drug administration. rhart-Harris RL et al., Lancet Psychiatry. 2016; 3(7):619-27; Carhart-Harris RL et al, Psychopharmacology (Berl). 2018; 235(2):399-408). In addition, The duration of psychedelic effects compared to available treatments and currently studied psychedelic drugs It would be beneficial not only to shorten the duration of treatment but also to have a more rapid onset of clinical response. Although it has been suggested that some psychiatric disorders may in principle be responsive to treatment with psychedelics, However, specific disease entities and specific subgroups of disease entities have yet to be identified.

[0031] It is therefore an object of the present invention to provide a method for treating a disease which is more effective (i.e., (a) a) a higher percentage of patients experiencing a floor response; b) a greater mean clinical response; d) improved psychoactive therapy with a more sustained clinical response; The present invention provides compounds for the method and dosing regimens for said therapy. A further objective is to provide a method for treating a patient with a therapeutically effective amount of cyclosporine, which has a better safety profile than previously described treatments and / or or compounds for improved, well tolerated psychoactive therapies and dosage forms for said therapies. Another object of the present invention is to provide a drug regimen that is simpler and more convenient than previously described treatments. The present invention provides compounds for improved psychoactive therapy and dosage regimens for said therapy. Another object of the present invention is to provide a method for treating a patient with a pulmonary bypass that provides a therapeutically effective treatment with a higher patient compliance than previously described treatments. and compounds for improved psychoactive therapies with improved treatment success rates (including higher treatment initiation rates). It is a further object of the present invention to provide a dosing regimen for said therapy. Specific disease entities and disease entities that would benefit from improved psychoactive treatments such as The aim is to identify subgroups.

[0032] Psychiatric disorders, especially major depressive disorder, persistent depressive disorder, anxiety disorder, and post-traumatic stress disorder Currently available treatments for body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse Treatment is often associated with limited or non-sustained treatment response, delayed response, and long-term drug administration. side effects that limit administration, and inconvenient dosing that often limit patient compliance Inadequate for regimen.

[0033] Some of these mental disorders are caused by LSD, psilocybin and DMT (a shamanic tea used in ayawa). Recently published studies have shown that serotonergic psychedelic drugs such as ska Clinical studies have demonstrated that these compounds may be alternatives to currently available treatments. However, even with these drugs, not all patients respond. However, some patients lose response over time and experience certain side effects. The acute psychoactive effects of the compounds and dosing regimens tested lasted for several hours after administration; These compounds present significant implementation and convenience issues, and the development of clinical responses is slow. , including in highly symptomatic patients or those at imminent risk of suicide. It is not rapid enough to treat patients with active suicidal ideation. Indications are in principle responsive to treatment with these serotonergic psychedelics. Although it has been shown that specific disease entities and specific subgroups of disease entities remain to be identified, It hasn't been done yet.

[0034] Therefore, the technical problem to be solved by the present invention is to provide a method for treating patients with mental disorders in a broad sense. This paper presents an improved psychoactive therapy based on the application of serotonergic psychedelics in The technical problem is to identify patients who would be responsive to treatment with such improved therapies. The present invention further encompasses the identification of mental disorders and subgroups of mental disorders.

[0035] Most serotonergic psychedelics act primarily through the 5-HT2A receptor. These are thought to mediate these psychoactive effects, although other receptors also play a role and may play a role in The pharmacology is somewhat complex. Furthermore, there are clear associations between various psychiatric conditions and specific 5-HT receptor systems. Since no clear correlation exists, it remains to be seen which specific receptor affinity profile of a psychedelic drug is most suitable. It is not easy to predict whether a treatment will have an optimal therapeutic effect.

[0036] The present inventors have demonstrated that the peak psychedelic experience during the acute phase following administration of a particular psychedelic drug The occurrence of the trial may be a causal or at least a surrogate behavioral marker of an underlying unknown therapeutic mechanism. As such, it was recognized that the therapeutic benefits of either

[0037] The inventors believe that the relationship between the type and intensity of psychedelic experiences may be important in preventing, for example, life-threatening cancer. This is supported by research on depression and anxiety in patients with Griffiths et al. The study reported that the psychiatric experience score showed a significant correlation with various treatment outcome measures after 5 weeks. It has been reported (Griffiths RR et al., J Psychopharmacol. 2016; 30(12):1181-1197). In addition, in cancer patients with anxiety and depression reported by Ross et al. Comparative studies in the United States have shown that the intensity of the subjective mystical experience during drug exposure is significantly related to clinical benefit. It was found that the effects of the GABAergic drug on the pharmacokinetics of GABAergic drugs were not related to the effect of the GABAergic drug (Ross S et al., J Psychopharmacol 2016; 30(12):1165-1180). Research on rosybin has shown that ocean sensations (OBN) (mystical-type experiences, such as oneness and bliss) The effects of psilocybin are more comprehensive than those of the visual and auditory effects of psilocybin. was also found to be significantly more predictive of reducing depressive symptoms (Roseman L et al., Front Pharmacol. 2018; 8:974). Furthermore, Bogenschutz et al. In a study of psilocybin in alcoholism, They found that the strength of the effect was highly predictive of change in drinking at weeks 5 to 8. (Bogenschutz MP et al., J Psychopharmacol. 2015; 29(3):289-99). Also, John In a study on tobacco dependence by Son et al., Patients who relapsed had significantly higher scores on an index of psilocybin-induced mystical experiences than those who relapsed. (Johnson MW et al., J Psychopharmacol. 2014; 28(11):983-92; Garcia- Romeu A, Curr Drug Abuse Rev. 2014;7(3):157-64. Similar observations have already been made, for example in this study of alcoholics treated with LSD. In alcohol-addicted individuals, "50 percent of them changed [i.e., became sober]." or much improved]... In principle, no change was observed in those who did not have a transcendental experience. They continue to drink alcohol, but a high percentage of those who have transcendental experiences do change." (Unger SM, quoted in Psychiatry. 1963; 26:111-25). In fact, these early 's experiences prompted the concept of "psychedelic therapy," discussed above.

[0038] The inventors have demonstrated the efficacy of acute psychedelics for long-term clinical improvement in a wide range of such psychiatric conditions. The main role of the type and intensity of the sleep experience is mediated through the so-called resting-state network (RSN). This may be explained by recent observations on functional connectivity (FC) in the human brain. These RSNs have been shown to be responsible for various aspects of complex cognitive functions. These connectivity networks are important in the pathogenesis of psychiatric disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety disorder. harm, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse. Furthermore, it may be disrupted in patients with suicidal ideation, which may occur concomitantly with these disorders. has been found.

[0039] The present inventors believe that the disruption of the normal hierarchical structure of RSNs is the final common pathway of these diseases. This may explain why many of the diseases involved can occur simultaneously in the same patient. The present inventor believes that: a) psychedelic drugs such as psilocybin, LSD and DMT are Administration of anti-inflammatory drugs can result in a decrease in connectivity within specific RSNs (Carhart-Harr et al., 2013). is RL et al., Sci Rep. 2017; 7(1):13187; Palhano-Fontes F et al., PLoS One. 2015 ; 10(2):e0118143; Carhart-Harris RL et al., Proc Natl Acad Sci US A. 2016; 113( 17):4853-8), and b) this reduction in connectivity correlated with ratings of peak experiences (Carhart-Harris RL et al. l., Sci Rep. 2017;7(1):13187; Carhart-Harris RL et al., Proc Natl Acad Sci USA 2016; 113(17):4853-8), c) reorganization of specific RSN activity (or normal functioning) after peak experiences In some cases, an increase in the number of patients with pulmonary hypertension (PHD) has been observed (Carhart-Harris RL et al., Sci Rep. 2017; 7(1): 13187), which d) correlates with treatment response (Carhart-Harris RL et al., Sci Rep. 2017; 7(1):13187) further teaches that the type and intensity of acute psychedelic experiences may influence therapeutic outcomes. This may explain the observation that it correlates with Utkam.

[0040] The inventors believe that the occurrence of peak experiences may be an important or minor mechanism for the therapeutic efficacy of psychedelic drugs. We have recognized that the present invention is at least a surrogate behavioral marker of the underlying mechanism. Participants reported more peak experiences compared with previously tested psychedelics and dosing regimens. Achieving this rapidly, in a higher percentage of patients, and with better reproducibility in individual patients The authors recognized that a more favorable therapeutic profile could be achieved by

[0041] The inventors have demonstrated that 5-MeO-DMT (see formula below) is a potent antipsychotic that induces peak experiences. The trend is for these drugs to be more effective than serotonergic psychedelics previously investigated for the treatment of neurological disorders. The authors further identified 5-MeO-DMT as a major serotonergic psychedelic drug. Peak experiences based on the principle of the collapse of ego boundaries and the experience of blissful states and / or oneness The inventors have also recognized that 5-MeO-DMT is a potential treatment for neurological disorders. This allows the drug to induce peak experiences more rapidly than previously studied serotonergic psychedelics. The inventors have found that the duration of the psychedelic experience is shorter when 5-MeO These characteristics of 5-MeO-DMT are associated with an improved therapeutic profile, suggesting that 5-MeO-DMT treatment We believe that this can be explained by specific changes in RSN activity based on

[0042] [ka]

[0043] In one aspect, the present invention relates to a method for treating a psychiatric disorder, in particular major depressive disorder, persistent depressive disorder, anxiety disorder, harm, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse. The present invention relates to the use of a therapeutically effective amount of 5-MeO-DMT in the treatment of such disorders. The use of therapeutically effective amounts of 5-MeO-DMT in This includes the use of a therapeutically effective amount of 5-MeO-DMT in patients with and use in patients with treatment-resistant forms of such disorders, including for use in patients with These conditions all involve perturbations in the activity of the RSN. It is known that these conditions are associated with 5-MeO-DM It was recognized that this caused patients to respond to treatment with T.

[0044] In another aspect, the present invention relates to a method for treating psychiatric disorders, particularly major depressive disorder, persistent depressive disorder, anxiety disorder, and the like. Disorders, Post-Traumatic Stress Disorder, Body Dysmorphic Disorder, Obsessive-Compulsive Disorder, Eating Disorders and Psychoactive Substance Disorders 2. The use of a therapeutically effective amount of 5-MeO-DMT in the treatment of is rapidly achieved following administration of 5-MeO-DMT.

[0045] In another aspect, the present invention relates to a method for treating psychiatric disorders, particularly major depressive disorder, persistent depressive disorder, anxiety disorder, and the like. Disorders, Post-Traumatic Stress Disorder, Body Dysmorphic Disorder, Obsessive-Compulsive Disorder, Eating Disorders and Psychoactive Substance Disorders 2. The use of a therapeutically effective amount of 5-MeO-DMT in the treatment of relates to use that continues for a long period following administration of 5-MeO-DMT.

[0046] In another aspect, the present invention relates to a method for treating psychiatric disorders, particularly major depressive disorder, persistent depressive disorder, anxiety disorder, and the like. Disorders, Post-Traumatic Stress Disorder, Body Dysmorphic Disorder, Obsessive-Compulsive Disorder, Eating Disorders and Psychoactive Substance Disorders A novel dosing regimen of 5-MeO-DMT for use in the treatment of a patient A novel method that allows the achievement of a high percentage of patients with excellent reproducibility in the same patient. The present invention relates to a dosing regimen that allows for a high success rate and a resulting improvement in therapeutic efficacy. In addition to reducing the risk of overmedication, these new dosing regimens also reduce the risk of overmedication. , thereby improving the safety profile. Such improved dosing regimens include: Subsequent doses of increasing doses of 5-MeO-DMT administered to the same patient on the same or following days It depends on what you do.

[0047] Through each of these aspects, and particularly through combinations of these aspects, the present invention 1) Improved psychoactive treatment based on the application of psychedelic drugs to patients with psychiatric disorders and 2) providing methods for identifying specific sperm that are responsive to treatment with such improved therapies. To solve the problem of identifying specific subgroups of psycho- and psychiatric disorders.

[0048] 5-MeO-DMT has a short duration of acute psychedelic effects (e.g., oral improved despite the fact that the effects were greater for 5-20 minutes after inhalation compared with several hours for cibin and oral LSD. The fact that it has such a therapeutic effect is surprising, and in fact the short duration of this action and Absence of associated tolerability (i.e., reduction or loss of psychedelic effect after re-administration) Absence of) is designed to increase the incidence of peak experiences and thereby increase therapeutic benefit. New dosing regimens with frequent repeated doses (e.g., more than once daily or daily) Repeated administration within such a short period of time also increases the risk of overdosing. This allows for individualized dose optimization to reduce the risk of serotonin syndrome and subsequent Negative psychological reactions such as flashbacks of past experiences, or physical side effects such as degenerative symptoms There is little or no memory of the state (the so-called "whiteout"), and it is less meaningful. This can provide a more effective psychedelic experience. Furthermore, by starting at a low dose, patients can Become familiar with the psychedelic experience in general and be prepared for the more intense symptoms that occur at higher doses. This can have a positive effect on the experience of these higher doses. The prospect of being able to start treatment at a dose that is consistent with patient acceptance of the treatment approach. This will increase patient acceptance and improve overall compliance rates at the patient population level.

[0049] Increasing the rate of peak experiences to adjust the reproducibility of peak experiences and improving the therapeutic effect. The aim of this study is to develop a serotonin-acting drug that reduces side effects and improves compliance. Frequent re-administration of therapeutic psychedelics is not contemplated in the prior art, and in fact re-administration may be the delayed onset and long duration of psychedelic effects observed with their current dosing regimens; and tolerance that can last for several days (i.e., reduction in psychedelic effects after re-administration). Due to the rapid onset of depression (hyperactivity disorder or loss), other psychedelic drugs are not currently being tested. Psychedelic drugs used in therapeutic settings may not be possible with a dosing regimen that is consistent with the current treatment regimen. The dosing regimens described so far for these drugs involve only a single administration or repeated administration after a few days. Therefore, these currently applied dosing regimens However, peak experience is not reliably achieved and these regimens do not provide the additional benefits discussed above. It brings no benefit.

[0050] 5-MeO-DMT acts as a 5-HT1A and 5-HT2A receptor agonist 5-M is a naturally occurring serotonergic psychedelic tryptamine. eO-DMT was first isolated from Dictyoloma incanescens. It was isolated from the bark of the tree, but is also found in other plants and is known to be the plant of the Colorado River Toad (Bufo alvar In addition, 5-MeO-DMT has been identified as the major active component in the venom of the Eucalyptus ius toad. It is synthesized in the human pineal gland and retina and is found in human body fluids, including urine, blood, and cerebrospinal fluid. 5-MeO-DMT is primarily detoxified through monoamine oxidase A (MAA)-mediated detoxification. Inactivated by the amination pathway, the cytochrome P450 2D6 (CYP2D6) enzyme It is O-demethylated by bufotenin to produce the active metabolite bufotenin. The drug binds to the 5-HT2A receptor with much higher affinity than 5-MeO-DMT itself. Combine.

[0051] Compositions containing 5-MeO-DMT in addition to 5-MeO-DMT and other active components has previously only been used in ritual or recreational situations (erowid.org / chemicals / 5meo_dmt / 5meo_dmt_dose.shtml and erowid.org / chemicals / 5meo_dmt / 5meo_dmt_effect s.shtml, accessed March 1, 2018). 5-MeO-DMT and other active components The patterns of use, motivations, and primary concerns associated with the use of compositions containing 5-MeO-DMT Recent internet studies aimed at examining the clinical effects and potential benefits and outcomes of Surveys have shown that self-reported symptoms include anxiety, depression, substance use problems and post-traumatic stress disorder. The majority of respondents with psychological conditions perceived improvement in symptoms related to these disorders. It was described (Davis AK et al., J Psychopharmacol. 2018 Jul;32(7):779-792). However, As described by the authors, "This study was cross-sectional and included no evidence of psychological symptoms. lack of established indicators and assessment of past psychological treatment, and includes many polysubstance users. , which limits causal inference about the relationship between 5-MeO-DMT use and symptom improvement. , so the association of psychological benefits remains observational."

[0052] The application of 5-MeO-DMT in combination with MAO inhibitors enhances and prolongs the drug's effects. Most commonly described in ritual or recreational settings. The proposed routes of administration of 5-MeO-DMT are smoke or vapor inhalation or intranasal instillation. However, other routes, such as intravenous, rectal or oral application, have also been described, with the latter route Absorption is substantially first-pass, possibly due to rapid action of MAO enzymes in the intestine and liver. is limited by

[0053] Advantageous Effects of the Invention The beneficial effects of the present invention compared to the current standard of care for each indication are: These include, but are not limited to, a) a higher percentage of patients experiencing a clinical response; b) a higher a) higher mean clinical response; b) faster onset of clinical response; c) more sustained clinical response; e) higher Similar or better clinical response with fewer or different side effects, thereby improving f) easier treatment regimens involving fewer medications and equivalent or better clinical responses, thereby improving compliance. In comparison to previously investigated psychedelic drugs, the present invention provides, for example, g) improved acute mental retardation following administration. Equivalent or better clinical response with shorter duration of neuroactive effect, resulting in improved h) improved convenience and compliance; and h) greater propensity to achieve peak psychedelic experiences. Greater reproducibility of the highest psychedelic experience while at the same time reducing unnecessary high doses and and associated side effects, thus improving patient outcomes with improved compliance. Further, the beneficial effect may be as defined herein. It is noted that this is particularly achieved in treatment-resistant patients.

[0054] definition As used in the context of the present invention, unless otherwise stated, the term "5-MeO-DMT" The term refers to the free base, 5-MeO-DMT. It is contemplated that acceptable salts may also be used. An example of such a salt is the hydrochloride salt. The appropriate weight of the salt to be used may be calculated from the weight of the free base assuming equimolar amounts are used. good.

[0055] As used in the context of the present invention, a "patient" to be treated is a A human subject is one who has been diagnosed with major depressive disorder by a qualified professional according to the method of claim 1. According to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) published by the American Psychiatric Association, Mental disorders, especially major depressive disorder, persistent depressive disorder, anxiety disorder, and post-traumatic stress disorder may be said to suffer from physical harm, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders or psychoactive substance abuse. Diagnosis is by a doctor or psychologist. Human subjects themselves identify themselves as having one of the disorders. It is insufficient to consider someone suffering from one of these conditions.

[0056] As used in the context of the present invention, "suicidal ideation" refers to thoughts, thoughts or plans to commit suicide. The presence of suicidal ideation in a patient is consistent with established protocols for diagnosing suicidality. The diagnosis is made by a doctor or psychologist using the diagnostic criteria and methods. It is generally insufficient to consider someone suffering from suicidal thoughts. Patients who do so are considered to be at imminent risk of suicide or to have the "intent to commit suicide." It is done.

[0057] As used in the context of the present invention, unless otherwise stated, the terms "treating" and "treatment" are used interchangeably. The term "treatment" refers to the management and management of patients with the aim of combating a disease, condition or disorder. includes care and alleviates the signs and / or symptoms of, or treats, a disease, condition or disorder This includes administration of the compounds and methods according to the present invention to eliminate

[0058] As used in the context of the present invention, unless otherwise stated, the term "therapeutically effective amount" , including alleviation of signs and / or symptoms of the disease, condition or disorder being treated. The biological or clinical response sought by a physician, physician or other clinician in humans By "active compound or pharmaceutical ingredient" is meant the amount of active compound or pharmaceutical ingredient that induces

[0059] "Clinical response" includes, but is not limited to, the Clinical Global Impression-Severity Scale (CGI-S) ), Patient Global Impression-Severity Scale (PGI-S), Clinical Global Impression-Improvement Scale ( Patient Global Impression-Improvement (PGI-I) or Patient Global Impression-Improvement (PGI-I) including, but not limited to, improvement in major depressive disorder and persistent depressive disorder The Montgomery-Asberg Depression Rating Scale (MADRS) or the 17-item Hamidi scale Measured by, for example, the HAM-D, the Beck Anxiety Inventory (BAI), Anxiety symptoms, Hamilton Anxiety Scale for Anxiety Disorders (HAM-A) or State-Trait Post-traumatic stress disorder clinical diagnostic interview (STAI), an assessment of post-traumatic stress disorder The Yale-Blind Patient Profile Scale (CAPS), a modified version of the Body Dysmorphic Disorder Scale, is used to measure body dysmorphic disorder. Lowen University Obsessive-Compulsive Disorder Rating Scale (BDD-YBOCS), Yale University's Obsessive-Compulsive Disorder Brown University Obsessive-Compulsive Scale (Y-BOCS), weight gain for anorexia nervosa In addition, the frequency of binge eating and vomiting episodes in bulimia nervosa and the frequency of binge eating episodes in binge eating disorder were frequency of withdrawal symptoms, duration of abstinence or reduction in substance use in psychoactive substance abuse; and Regarding suicidal ideation, the Columbia-Suicide Severity Rating Scale (C-SSRS) and other suicidality assessment scales or the suicidal thoughts item of the MADRS, or the Clinical Global Impression Scale-Suicidality Severity-Revised ( The CGI-SS-R is derived from the CGI-S, with 0 = normal, 1 = not suicidal 1 = no tendency, 2 = suspected suicidal tendency, 3 = moderate suicidal tendency, 4 = suspected suicidal tendency, = marked suicidality, 5 = severe suicidality, 6 = extreme suicidality), etc. Longer recall periods (e.g., typically 7 days for MADRS) Based on the endpoints developed for When determining clinical response, reasonable modifications of such endpoints (e.g., MADR The recall period for Ss was changed to 2 hours, and the sleep items recorded at baseline before drug administration were repeated. may be applied.

[0060] As used in the context of the present invention, unless otherwise stated, "administration" (or "application") The term refers to the administration of a quantity of an active compound or pharmaceutical ingredient via any route, which may be a predetermined amount. Preferably, the active compound is administered intranasally or by inhalation. , by buccal administration, or by sublingual administration.

[0061] As used in the context of the present invention, unless otherwise stated, the terms "dose" and "administration" and and the term "dosage" refers to the amount of active compound or pharmaceutical ingredient administered to a patient in an individual administration. The term "dosage regimen" (or "dosage regimen") means one or more means a predefined sequence of multiple individual administrations.

[0062] As used herein, "aerosol" refers to a gaseous medium (such as air) that is pharma- ceutically acceptable. A stable system consisting of a gas (which is dispersed in a liquid) and small suspended solid and / or liquid particles. It means.

[0063] The term "decomposition product" refers to the 5-MeOH derivatives that form as a result of chemical reactions during aerosol formation. It refers to compounds obtained by chemical modification of O-DMT. Such reactions include, but are not limited to, Oxidation is one example.

[0064] When the percentage of "degradation products" is described in the context of the present invention, the percentage of The amount of 5-MeO-DMT decomposition products in the sample was calculated by dividing the amount of 5-MeO-DMT and 5-MeO- Divide by the amount of DMT decomposition products and multiply by 100%, i.e. ( (the sum of all 5-MeO-DMT degradation products present in the sample) / ((the (amount of 5-MeO-DMT present) + (total amount of 5-MeO-DMT present in the sample) This refers to the total amount of decomposition products x 100%.

[0065] As used herein, the term "impurity" refers to 5-MeO-DMT (or any other Impurities refer to undesired compounds that contaminate a sample of aerosols (chemically acceptable salts thereof). It may be contained in the starting materials prior to sol formation or it may be a decomposition product.

[0066] The term "purity" refers to all 5-MeO-DMT degradation products and all other products that are present. The percentage of impurities subtracted from 100%, i.e. (100% - (all present) The sum of the amounts of all 5-MeO-DMT degradation products plus the sum of the amounts of all other impurities present. Total) / (amount of 5-MeO-DMT present + all 5-MeO-DMT decomposition present Impurities present in the final product are multiplied by 100% (sum of the product content + sum of the amounts of all other impurities present).

[0067] The term "mass median aerodynamic diameter" (MMAD) refers to the 5 mm diameter of a particle present in an aerosol. 0% is a diameter larger than this calculated diameter and 50% is a diameter smaller than it.

[0068] The term "mass density of aerosol particles" refers to the mass of aerosol particles per unit volume of aerosol. This refers to the mass of a particle.

[0069] The term "rate of formation of aerosol particles" refers to the rate of aerosolization per unit of aerosolization time. This refers to the mass of solated 5-MeO-DMT.

[0070] Aspects of the invention The present invention relates to a method for treating a patient, as defined herein, comprising administering a therapeutically effective amount of 5-MeO-DMT or a pharmaceutical The present invention relates to a method for treating mental disorders, particularly major depressive disorder, persistent depression, and the like, comprising administering to a subject a salt thereof that is acceptable for Illness disorders, anxiety disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and The present invention is directed to improved methods for the treatment of psychoactive substance abuse. Treatment of these disorders includes: including, but not limited to, those with such disorders and suicidal ideation, as defined herein. The present invention relates to the use of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof in a patient. The treatment of the disorders described herein is carried out in patients, as defined herein, who have, in particular, a treatment-resistant form of the disorders mentioned. The present invention relates to the use of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof in When used in this context, "treatment-resistant" refers to major depressive disorder and persistent depressive disorder. , for at least two adequate courses of pharmacological treatment in the current depressive episode defined as lack of adequate improvement, anxiety disorder, post-traumatic stress disorder, body dysmorphic disorder and In obsessive-compulsive disorder, at least one adequate course of pharmacological treatment and at least one adequate course of psychotherapy defined as no adequate improvement for at least one adequate course, and eating disorders and For psychoactive substance abuse, at least one session of psychotherapy with or without pharmacological treatment is required. The condition is defined as the absence of adequate improvement following an appropriate course of treatment. Adequacy of improvement depends on the clinical response. The appropriateness of the course of treatment is assessed in terms of the regimen, dose, duration and Compliance is judged by the physician or The psychologist assessed and recorded the results, and the patient reported that the previous treatment process was inappropriate or It is not enough for the respondent to consider that he or she did not respond appropriately. Appropriateness is measured both retrospectively and It may be determined prospectively.

[0071] Treatment of patients with anxiety disorders includes, but is not limited to, panic disorder, phobias, This includes patients with anxiety disorders, social anxiety disorder and generalized anxiety disorder. Treatment of patients with anorexia nervosa, bulimia nervosa and binge eating disorder includes, but is not limited to, Treatment of patients with substance abuse includes, but is not limited to, alcohol, opioid-related disorders; sedative-, hypnotic- or anxiolytic-related disorders; cocaine-related disorders This includes patients with nicotine dependence, other stimulant-related disorders and nicotine addiction.

[0072] Disorders preferably treated by the present invention are major depressive disorders, including their treatment-resistant forms. Most preferred according to the present invention are generalized anxiety disorder, obsessive-compulsive disorder and anorexia nervosa. The disorders most commonly treated are major depressive disorder, including its treatment-resistant forms, and those with suicidal ideation. This includes patients with major depressive disorder.

[0073] In embodiments, such as those disorders of treatment-resistant type, and those disorders associated with suicidal ideation. mental disorders, especially major depressive disorder, persistent depressive disorder, anxiety disorder, and post-traumatic stress disorder harm, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse, The dosage of 5-MeO-DMT administered to a defined patient ranges from about 1 mg to about 25 mg. or any amount within a range therein, preferably about 2 mg to about 20 mg, more preferably about 4 mg to about 20 mg. Specific useful amounts are, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about 12 mg, about 14 mg, about 16 mg, about 18 mg, and about 20 mg The patient may be treated with an equimolar dose of a pharma- ceutically acceptable salt of 5-MeO-DMT. In the present specification, when a range such as "about 1 mg to about 25 mg" is described, the present inventors Although some of them are mentioned in detail, it is understood that all individual values ​​within the range are contemplated and should not be construed as limiting the scope of the invention. Note that for the sake of brevity, not all of them are mentioned.

[0074] In a preferred embodiment, the present invention includes treatment-resistant forms of these disorders, and also those associated with suicidal ideation. Mental disorders, especially major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic have stress disorders, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse; Improved methods for treating a patient as defined herein with a therapeutically effective amount of 5-MeO-DMT. The methods include the occurrence of a clinical response within about 2 hours after administration of 5-MeO-DMT.

[0075] In a preferred embodiment, the treatment-resistant forms of these disorders, as well as those associated with suicidal ideation, are also included. Mental disorders, especially major depressive disorder, persistent depressive disorder, anxiety disorder, post-traumatic stress disorder, etc. with stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder and psychoactive substance abuse. Improved methods for treating a patient as defined herein with a therapeutically effective amount of 5-MeO-DMT. The method includes administering 5-MeO-DMT to a subject, the subject receiving the 5-MeO-DMT, and / or a subject receiving the 5-MeO-DMT. The last dose of 5-MeO-DMT should be administered at least about 6 days after the last dose of 5-MeO-DMT. and preferably at least about 14 days after the last administration of 5-MeO-DMT. The present invention includes a sustained clinical response for at least about 28 days after administration of the compound.

[0076] In a preferred embodiment, the treatment-resistant forms of these disorders, as well as those associated with suicidal ideation, are also included. Mental disorders, especially major depressive disorder, persistent depressive disorder, anxiety disorder, post-traumatic stress disorder, etc. with stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder and psychoactive substance abuse. Improved methods for treating a patient as defined herein with a therapeutically effective amount of 5-MeO-DMT. The methods involve administration of more than a single dose of 5-MeO-DMT.

[0077] In a preferred embodiment, the more than single dose of 5-MeO-DMT is administered in one or is administered to patients in multiple treatment blocks, with each block consisting of 2 to 7 administrations. The time between each administration within a block is at least about 1 hour and not more than about 24 hours, and administration is continued until the end of a treatment block. There is approximately 6 days or more between the end of the first and the start of the next treatment block.

[0078] In an even more preferred embodiment, more than a single dose of the 5-MeO-DMT is administered. The drug is administered to patients in one or more treatment blocks, with each block consisting of one to three doses. There was approximately 24 hours between each administration within each treatment block, and the end of one treatment block was followed by the next There are about 6 or more days between the start of the treatment blocks.

[0079] In a most preferred embodiment, the more than one dose of 5-MeO-DMT is administered or administered to patients in multiple treatment blocks, with each block consisting of 1 to 3 administrations, The time between each administration within a treatment block was approximately 2-4 hours, and the end of one treatment block was followed by the next treatment block. There are approximately 6 or more days between the start of placement blocks.

[0080] In embodiments, individual patients are dosed in each administration and each treatment block. The dosage of 5-MeO-DMT administered is consistent for each individual patient and ranges from about 1 mg to about 25 mg, preferably about 2 mg to about 20 mg, more preferably about 4 mg to about 20 mg Useful specific amounts are, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about 12 mg, about 14 mg, about 16 mg, about 18 mg and about 20 mg.

[0081] In a preferred embodiment, the dosage of 5-MeO-DMT administered to an individual patient is The first dose in the placement block is chosen from about 2 mg to about 8 mg, and then reaches 20 mg. or all doses in that treatment block are administered, whichever occurs first. with each subsequent administration within each treatment block, until

[0082] In an even more preferred embodiment, the dosage of 5-MeO-DMT administered to an individual patient The amount is selected from about 2 mg to about 8 mg for the first administration within each treatment block, followed by 20 mg is reached, or all doses in that treatment block are administered, or the patient Based on whether the individual experiences a peak psychedelic experience or whether the supervising physician observes any side effects, Each treatment is continued until the sooner of determining that further dose escalation is inappropriate. Increased with each subsequent administration within the block.

[0083] In embodiments where the dosage is increased with subsequent administrations, the dosage of the next administration is increased by 100% relative to the dosage of the previous administration. Add about 2 mg to about 10 mg, preferably about 4 mg to about 8 mg, and most preferably about 6 mg. For example, the dosage for the first administration is 6 mg, and the dosage increase is If the dose is 6 mg, administration of the second dose will be discontinued unless one of the discontinuation criteria above is reached. The dosage is 12 mg. Preferably, the dosage of the third administration is 18 mg.

[0084] In a preferred embodiment, 5-MeO- is administered to individual patients in each treatment block. The dosage of the DMT is selected from about 2 mg to about 8 mg for the first administration, and thereafter the patient is administered Unless the participant has already had a peak psychedelic experience within the treatment block, or the supervising physician Unless it has been determined that further dose escalation is inappropriate based on observed side effects, The second administration is at a dose selected from about 8 mg to about 14 mg, and the third administration is at a dose selected from about 1 The dose is increased to a dose selected from 4 mg to about 20 mg. Useful specific amounts are, for example, about 6 mg, about 12 mg, and about 18 mg.

[0085] In an even more preferred embodiment, the dosage of 5-MeO-DMT administered to an individual patient The amount is selected from about 2 mg to about 8 mg for the first administration of the first treatment block, and then 0 mg is reached or all doses in that treatment block are administered, or Based on whether the patient experiences a peak psychedelic experience or whether the supervising physician observes side effects, The first dose is increased until the earlier of either the first or second dose escalation being determined to be inappropriate. Increased with each subsequent dose within a treatment block, up to the maximum dose in that first treatment block The amounts are for all subsequent treatment blocks and administration within those subsequent treatment blocks. For example, the maximum dose in the first treatment block is used as the dose at which the patient If a person experienced a peak psychedelic experience at a dose of 18mg, all subsequent The dose for administration within the first and subsequent treatment blocks was 18 mg. be.

[0086] In a most preferred embodiment, the dosage of 5-MeO-DMT administered to an individual patient is: The first dose of the first treatment block is selected from about 2 mg to about 8 mg, and then the patient receives Unless the participant has already had a peak psychedelic experience within the treatment block, or the supervising physician unless the FDA has determined that further dose escalation is inappropriate based on observed side effects. the second administration of the first treatment block is at a dose selected from about 8 mg to about 14 mg; and in the third administration of the first treatment block, a dose selected from about 14 mg to about 20 mg. The maximum dose in that first treatment block was increased to 100 mg / kg / day for all subsequent treatment blocks. The doses are used as the doses for administration in the first and subsequent treatment blocks. A useful specific amount for the first, second and third administrations in a treatment block is, for example, about 6 mg. , about 12 mg and about 18 mg.

[0087] Pharmaceutically acceptable salts of 5-MeO-DMT may also be used in all of the above dosing regimens. The appropriate weight of the salt to be administered is the stated weight of the free base, assuming equimolar amounts are used. It is understood that the weight may be calculated.

[0088] According to the present invention, 5-MeO-DMT is preferably not administered with an MAO inhibitor. stomach.

[0089] The occurrence of "peak psychedelic experiences" in patients was assessed using the 30-item Revised Mystical Experiences Questionnaire. The four subscales of the MEQ30 (Mystical, Positive Mood, Transcendence of Time and Space, and Expression) by achieving at least 60% of the highest possible score on each of the following criteria: (As described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90) and the score items are shown in Example 4).

[0090] The occurrence of "peak psychedelic experiences" in patients has also been linked to altered states of consciousness (ASC) questionnaires. Identified by achieving at least 60% of the highest possible score on the Ocean Feeling (OBN) aspect of the vote. (as described in Roseman L et al., Front Pharmacol. 2018; 8:974).

[0091] The occurrence of "peak psychedelic experiences" in patients was also assessed using the Peak Psychedelic Experience Questionnaire. by achieving a score of at least 75 on the PPEQ total score. This is often based on three questions: 1. How powerful was the experience? 2. How powerful was the experience? 3. How profound (i.e., deep and significant) was the experience? , which is the average of responses scored by patients on a scale of 0 to 100.

[0092] Therapeutically effective amounts of 5-MeO-DMT can be administered by inhalation, intranasally, or bucally. Administration via these routes provides rapid action. The most preferred route of administration is by inhalation. Preferably, the therapeutically effective amount of 5-MeO-DMT is inhaled in a single breath.

[0093] For nasal administration, 5-MeO-DMT is administered either as a neat substance or in a nasal formulation. For nasal administration, 5-Me may be used in various forms, examples of which are known in the art. O-DMT may be administered as a pharma- ceutically acceptable salt or in the form of a pharma- ceutically acceptable salt formulation. Examples of suitable devices are known in the art.

[0094] For buccal or sublingual administration, 5-MeO-DMT may be administered by itself or in a formulation, e.g. They may be utilized in the form of tablets, films, sprays, and creams, examples of which are known in the art. In addition, buccal or sublingual administration of 5-MeO-DMT is The salts may be formulated per se or in formulations commonly known in the art, such as tablets, films, It may be applied in the form of a spray or cream.

[0095] Administration is in particular by inhalation of an aerosol. Such an aerosol may comprise: (a) a drug; (b) 5-methoxy-N,N-dimethyltryptamine (5-Me O-DMT) or a pharma- ceutical acceptable salt thereof, the aerosol comprising about 0.5 mg / l to about 12.5 mg / l, preferably about 1.3 mg / l to about 10 mg / l, In particular, it has an aerosol particle mass density of about 2 mg / l to about 9 mg / l. The gas used is preferably air.

[0096] The aerosol particles preferably contain less than 1 wt. % impurities, in particular less than 0.5 wt. % impurities. They further preferably contain The 5-MeO-DMT obtained by chemical modification is less than 0.5 wt%. Contains MT degradation products, particularly less than 0.2 wt% 5-MeO-DMT degradation products.

[0097] In a further preferred embodiment, the aerosol is (a) air; (b) 5-MeO-DMT or consists essentially of aerosol particles of a pharma- ceutically acceptable salt thereof.

[0098] The aerosol particles preferably contain 5-MeO-DMT in the free base form.

[0099] The aerosol preferably has an aerodynamic mass of less than 3 microns and greater than 0.1 microns. By median diameter, specifically by aerodynamic mass median diameter less than 2 microns and greater than 0.1 microns Can be characterized.

[0100] The aerosol comprises: a) 5-MeO-DMT formulated on a solid support or a pharma- ceutical acceptable salt thereof; b) exposing a thin layer of the salt to thermal energy; and The thin layer may be formed by passing air over the layer to create aerosol particles. The thin layer may have a thickness of less than about 10 μm, in particular less than about 7.5 μm. It may have a thickness in the range of about 10 μm, particularly in the range of about 0.3 μm to about 7.5 μm.

[0101] A thin layer of 5-MeO-DMT assembled on a solid support is then transferred to the membrane via air passing over the thin layer. Alternatively, 5-MeO-D may be prepared by exposing the 5-MeO-D to heat energy. A thin layer of MTs may be exposed to thermal energy through the solid support.

[0102] The air passing over the thin layer may have a temperature in the range of about 180° C. to about 260° C. The air passing above may in particular have a temperature of about 210° C. and is blown at a rate of about 12 L / min for about 15 seconds. The thin layer may be penetrated for a duration of time between 100 and 200 s.

[0103] The aerosol particles are contained in a volume of about 3 liters or less, particularly about 2 to about 3 liters. The aerosol may be particularly intended for use in therapy. It is preferably delivered to the patient in a single inhalation.

[0104] The present invention relates to a method for producing 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in a form suitable for inhalation in a medical setting. The present invention aims to provide a method for the preparation of 5-Me 2 -tert-butyl ether salts thereof, in particular in the form of an aerosol. The present invention provides aerosols having therapeutic efficacy, such as O-DMT and pharma- ceutical acceptable salts thereof. Suitable aerosols are available that are suitable for administering an effective dose of the aerosol to a patient in a single inhalation. has the mass density of the aerosol particles.

[0105] Aerosols useful in the present invention can be formed using thermal energy. When using a gas to form an aerosol of a compound, the aerosol may be delivered to the patient via the lungs. What conditions are safe, efficient, and predictable for systemic delivery of the compound to the It is very difficult to predict which materials will be suitable for solization. The factors that influence the aerosolization include a) the dose of the compound, and b) the morphology in which the compound becomes available for aerosolization. c) the thermal energy to which the compound is exposed ) the amount of ghee (defined by the temperature and duration of exposure) and d) the aerosol generated. The volume of air (defined by the flow rate and duration of the air flow) introduced to Some examples include:

[0106] The present invention relates to the administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a patient by inhalation. The objective of the present invention is to provide compositions and methods for safe, efficient and predictable systemic delivery of "Safe" means that the aerosol particles contain very few impurities and 5-MeO-DMT degradation products. "Efficient" means that the dosage should contain only a predetermined amount of Preferably, the aerosol is nearly completely or completely aerosolized, and the aerosol is primarily distributed in the alveoli. Systemic delivery of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof via the lungs through absorption by the and that the aerosol has desirable physical properties for delivery in a single inhalation (i.e., 1 "Predictable" means that the drug can be inhaled by the patient (within one deep breath) and "predictable" means that the drug can be inhaled by the patient within one deep breath. There is little or no variation in the amount of product, the degree of aerosolization, and the physical properties of the aerosol. This means that it shouldn't happen.

[0107] A suitable aerosol comprises: a) dispensing a therapeutically effective amount of 5-MeO-DMT as a thin layer onto a solid support; b) applying a thin layer of 5-MeO-DMT to a controlled temperature ramp for a short duration. and c) providing a controlled amount of air so that an aerosol is formed. This may be achieved by:

[0108] A composition for delivery of a therapeutically effective amount of 5-MeO-DMT may comprise an aerosol, The aerosol is a) a thin layer of 5-MeO-DMT formed on a solid support, which is then heated with thermal energy. and b) by passing air over a thin layer of 5-MeO-DMT. The aerosol is formed having the following characteristics: 1) an aerodynamic mass median diameter of less than 3 microns; 2) containing less than 1 wt. % impurities and 0. Containing aerosol particles characterized by less than 5% 5-MeO-DMT degradation products and 3) capable of being delivered to a patient in a single inhalation.

[0109] The amount of particles less than 3 microns in the volume of aerosol that can be delivered to a patient in a single inhalation characterized by an aerodynamic mass median diameter of less than 1 wt.% impurities and 0.5% The generation of aerosol particles having less than 5-MeO-DMT drug degradation products is b) the dosage of 5-MeO-DMT contained in the thin layer of 5-MeO-DMT; the thickness of the thin layer, c) the thermal energy to which the thin layer of 5-MeO-DMT is exposed (temperature of exposure and and d) the amount of air passing over a thin layer of 5-MeO-DMT. By defining the total volume (defined by the air flow rate and duration of the air flow) is achieved.

[0110] Preferably, the thin layer of 5-MeO-DMT is heated by heat energy via air passing over the thin layer. The heated air passing over the thin layer is heated to about 180°C. The air passing over the layer may have a temperature in the range of about 210° C. to about 260° C. The optical axis may have a degree.

[0111] Alternatively, a thin layer of 5-MeO-DMT can be exposed to thermal energy via a solid support, In this case, the air passing over the thin layer is not heated, but the solid support is heated. The support may have a temperature in the range of about 180°C to about 420°C.

[0112] Preferably, the 5-MeO-DMT used to form the thin layer on the solid support is highly pure. It is pure and has a purity of at least 99%, preferably at least 99.5%.

[0113] Preferably, the 5-MeO-DMT is contained in a thin layer of 5-MeO-DMT constructed on a solid support. The dosage of eO-DMT is about 1 mg to about 25 mg, preferably about 2 mg to about 20 mg, more preferably about 1 mg to about 25 mg. More preferably, it is about 4 mg to about 20 mg. Specific useful amounts are, for example, about 4 mg, about 6 mg, g, about 8 mg, about 10 mg, about 12 mg, about 14 mg, about 16 mg, about 18 mg, and about Preferred specific amounts are, for example, about 6 mg, about 12 mg, and about 18 mg. be.

[0114] The solid support on which 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is provided may be any of a variety of solid supports. Examples of such shapes include, but are not limited to, a 1.0 mm diameter Cylinders less than 1.0 mm thick, boxes less than 1.0 mm thick, and small (e.g. sizes less than 1.0 mm The solid support may be of any shape that is permeable by pores. has a large surface-to-volume ratio (e.g., greater than 100 per meter) and a large surface Provides a mass ratio (e.g., greater than 1 cm2 per gram).

[0115] A solid support of one form can also be converted into another form having different properties. For example, a 0.25 mm thick flat sheet has approximately 8,000 surface pairs per metre. By rolling the sheet into a hollow cylinder with a diameter of 1 cm, the height of the original sheet is reduced. It retains a high surface-to-mass ratio but has a lower surface-to-volume ratio (approximately 400 per meter). A support is prepared.

[0116] A number of different materials are used to construct solid supports. Materials include, without limitation, metals, inorganic materials, carbon materials and polymers. The following are examples of material classes: aluminum, silver, gold, stainless steel, copper and tin. silica, glass, silicon and alumina; graphite, porous carbon, carbur Bon yarn and carbon felt; polytetrafluoroethylene and polyethylene Recall. Combinations of materials and coated versions of materials are also used.

[0117] When aluminum is used as the solid support, aluminum foil is the preferred material. Examples of silica, alumina and silicon based materials include amorphous silica S-5631 (Sigma, St. Louis, MO), BCR171 (Aldrich, MO) St. Louis alumina with a specified surface area greater than 2 m2 / g) and the semiconductor industry Examples of carbon fibers include silicon wafers used in the manufacture of carbon fiber. Carbon yarn and carbon felt are Available from American Kynol, Inc., New York, NY be.

[0118] Preferably, the thickness of the thin layer of 5-MeO-DMT formed on the solid support is about 10 μm. The thin layer is in the range of about 0.1 μm to about 10 μm, particularly 0. It may have a thickness in the range of 0.3 μm to 7.5 μm.

[0119] Preferably, the total amount of air passing over the thin layer of 5-MeO-DMT is about 6 L / min. between about 8 liters per minute and about 40 liters per minute, preferably between about 8 liters per minute and about 40 liters per minute. and a total aerosol volume not exceeding about 3 liters; The duration of the air flow is preferably selected to be between about 2 liters and 3 liters. For example, at an air flow rate of about 6 liters per minute, the duration of the air flow is The specific air flow rate and duration useful should be less than about 30 seconds. 12 liters and about 15 seconds, which resulted in an aerosol volume of about 3 liters. Another useful specific air flow rate and duration is 10 liters per minute and Approximately 15 seconds, which results in an aerosol volume of approximately 2.5 liters. A useful specific air flow rate and duration is 8 liters per minute and approximately 15 seconds. This results in an aerosol volume of approximately 2 liters. Another useful specific air flow rate and duration is 10 liters per minute and approximately 12 seconds, which results in approximately 2 liters This results in an aerosol volume of 1000 torr.

[0120] The rate of aerosol formation is greater than 0.1 mg / sec.

[0121] The aerosol has a concentration of about 0.5 mg / l to about 12.5 mg / l, preferably about 1.3 mg / l. Aerosol particles having a mass density of about 2 mg / l to about 9 mg / l. do.

[0122] 5-MeO-DMT aerosol particles are less than 3 microns and greater than 0.1 microns. Preferably less than 2.5 microns and greater than 0.1 microns, most preferably 2 microns It is characterized by an aerodynamic mass median diameter of less than 0.1 microns and greater than 0.1 microns.

[0123] The 5-MeO-DMT aerosol particles contain less than 1 wt. % impurities, preferably less than 0.5 wt. % impurities. 5-MeO-DMT aerosol particles are characterized by less than 0.5 Less than 5-MeO-DMT degradation products by weight, preferably less than 0.2 wt% of 5-MeO- Characterized by DMT breakdown products.

[0124] A composition for delivery of a therapeutically effective amount of 5-MeO-DMT may comprise an aerosol, The aerosol was prepared by: a) forming a thin layer of 12 mg of the aerosol on a solid support, less than 5 microns thick; A dose of 5-MeO-DMT was applied to the thin layer of heated air for a duration of 15 seconds. The aerosol is formed by exposing it to a temperature of 210° C. by passing it through Characteristics: 1) Aerosol particles characterized by an aerodynamic mass median diameter of less than 3 microns. 2) less than 1% impurities and less than 0.5 wt% 5-MeO-DMT decomposition 3) aerosol particles characterized by a product that can be delivered to the patient via a single inhalation; can be delivered.

[0125] Those skilled in the art who are familiar with the characteristics of the aerosols and the aerosolization conditions defined in the present invention will be able to Identifying a suitable vaporization device or system that produces the required aerosol characteristics Examples of such suitable vaporization devices or systems include, for example, drip Volcano Medic Vapori with accompanying medication capsule with pad zation System (Storz & Bickel, Germany; see European Patent No. No. 933093 and European Patent No. 1884254 and Community Registered Design 0 03387299-0001) and the Staccato device (Ale xza Pharmaceuticals, Mountain View, USA; see e.g. U.S. Pat. Nos. 7,458,374, 9,370,629 and U.S. Pat. (disclosed in US Pat. No. 9,687,487).

[0126] The generated aerosols are collected in a balloon and inhaled by the patient. good.

[0127] Patients may also undergo psychotherapeutic intervention.

[0128] In a particular embodiment, the disease being treated is major depressive disorder. In some embodiments, the patient may suffer from treatment-resistant major depressive disorder. Patients may also suffer from suicidal thoughts with the intention to carry them out and may be at imminent risk of suicide. In this same particular embodiment, the patient may be considered to be in the depression category. The dosage of 5-MeO-DMT administered to a patient as defined herein is from about 4 mg to about 20 mg. In this particular embodiment, the 5-Me Useful specific amounts of O-DMT include, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about 12 mg, about 14 mg, about 16 mg, about 18 mg and about 20 mg. Patients also Patients may be treated with an equimolar dose of a pharma- ceutically acceptable salt of 5-MeO-DMT.

[0129] In a particular embodiment, the disease being treated is major depressive disorder. In some embodiments, the patient may suffer from treatment-resistant major depressive disorder. Patients may also suffer from suicidal thoughts with the intention to carry them out and may be at imminent risk of suicide. In this same particular embodiment, the patient may be considered to be in the depression category. The dosage of 5-MeO-DMT administered to a patient as defined herein is from about 4 mg to about 20 mg. In this particular embodiment, the 5-Me Useful specific amounts of O-DMT include, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about 12 mg, about 14 mg, about 16 mg, about 18 mg and about 20 mg. In an embodiment of the present invention, the MADR score is compared to the respective score before administration of 5-MeO-DMT. A clinical response as determined by at least a 50% improvement in S or HAM-D score; and was judged as at least a “marked improvement” in the CGI-I or PGI-I score. The clinical response observed occurs within approximately 2 hours after administration of 5-MeO-DMT.

[0130] In a particular embodiment, the disease being treated is major depressive disorder. In some embodiments, the patient may suffer from treatment-resistant major depressive disorder. Patients may also suffer from suicidal thoughts with the intention to carry them out and may be at imminent risk of suicide. In this same particular embodiment, the patient may be considered to be in the depression category. The dosage of 5-MeO-DMT administered to a patient as defined herein is from about 4 mg to about 20 mg. In this particular embodiment, the 5-Me Useful specific amounts of O-DMT include, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about 12 mg, about 14 mg, about 16 mg, about 18 mg and about 20 mg. In an embodiment, the diagnosis is made by a MADRS score of 10 or less or a HAM-D score of 7 or less. Measured remission of depressive symptoms occurs within approximately 2 hours after administration of 5-MeO-DMT.

[0131] In a particular embodiment, the disease being treated is major depressive disorder. In some embodiments, the patient may suffer from treatment-resistant major depressive disorder. Patients may also suffer from suicidal thoughts with the intention to carry them out and may be at imminent risk of suicide. In this same particular embodiment, the patient may be considered to be in the depression category. The dosage of 5-MeO-DMT administered to a patient as defined herein is from about 4 mg to about 20 mg. In this particular embodiment, the 5-Me Useful specific amounts of O-DMT include, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about 12 mg, about 14 mg, about 16 mg, about 18 mg and about 20 mg. In embodiments, the clinical response occurs within about 2 hours after administration of 5-MeO-DMT. MADRS or HAM-D scores compared with their respective scores before administration of 5-MeO-DMT Clinical response as determined by at least a 50% improvement in score or CGI-I or A clinical response, measured as at least a "marked improvement" PGI-I score, was 5. - Until at least about 6 days after the last dose of MeO-DMT, preferably 5-MeO-DM and at least about 14 days after the last dose of T, more preferably after the last dose of 5-MeO-DMT. The effect lasts for at least about 28 days following administration of

[0132] In a particular embodiment, the disease being treated is major depressive disorder. In this embodiment, the dosage of 5-MeO-DMT administered to an individual patient is The first dose is selected from about 2 mg to about 8 mg, and the patient then receives Unless you have already experienced a high psychedelic experience, or are aware of any side effects observed by a supervising physician, of the first treatment block unless it is determined that further dose escalation is inappropriate based on The second administration is at a dose selected from about 8 mg to about 14 mg, and the first treatment block is at a dose selected from about 8 mg to about 14 mg. The third dose of the drug is increased to a dose selected from about 14 mg to about 20 mg, and the first dose of the drug is increased to a dose selected from about 14 mg to about 20 mg. The maximum dose in a treatment block is the same as that in all subsequent treatment blocks and their is used as the dose for administration in the next treatment block. Useful specific amounts for the first, second and third administrations are, for example, about 6 mg, about 12 mg and about In this same particular embodiment, the interval between each administration in the first treatment block is 18 mg. In this same particular embodiment, 5-MeO-DMT is administered by inhalation for about 3 hours. In this same particular embodiment, the occurrence of a peak psychedelic experience is determined by a test of 30 items. The four subscales of the Revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive mood, time-space) At least 60% of the maximum possible score on each of the four dimensions (transcendence and ineffability) achievement (as described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90), and by achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. It is identified as such.

[0133] In a more particular embodiment, the disease to be treated is major depressive disorder. In embodiments, the dose of 5-MeO-DMT administered to an individual patient in each treatment block is The dosage is selected from about 2 mg to about 8 mg for the first administration, after which the patient is administered the treatment block. Unless the participant has already had a peak psychedelic experience within the facility or is being observed by a supervising physician, The second dose should be administered unless it is determined that further dose escalation is inappropriate based on side effects. the first dose is at a dose selected from about 8 mg to about 14 mg, and the second dose is at a dose selected from about 14 mg to about 20 mg to a dose selected from the first, second and third doses in the first treatment block. Useful specific amounts for the first and second administrations are, for example, about 6 mg, about 12 mg, and about 18 mg. In this same particular embodiment, the interval between each administration within each treatment block is about 3 hours. The interval between the end of one treatment block and the start of the next treatment block is approximately 6 days. In the same particular embodiment, the 5-MeO-DMT is administered by inhalation. In one embodiment, the occurrence of a peak psychedelic experience is assessed using the 30-item Revised Mystical Experiences Questionnaire ( The four subscales of the MEQ30 (mystical, positive mood, time-space transcendence, and ineffability) Achieving at least 60% of the highest possible score on each of the following criteria (Barrett FS, J Ps 2015;29(11):1182-90), or at least 75 of the highest This is identified by achieving a total score on the Psychedelic Experience Questionnaire (PPEQ).

[0134] In certain embodiments, the disease being treated is treatment-resistant major depressive disorder. In certain embodiments, the patient may suffer from suicidal thoughts with the intent to carry them out and may have suicidal thoughts. In this same particular embodiment, the individual patient may be considered to be at imminent risk. The dosage of 5-MeO-DMT administered is approximately 2 mg for the first administration of the first treatment block. ~8mg, and then the patient experiences a peak psychedelic experience within that treatment block. Further dose increases are not recommended unless already experienced or based on observed side effects by the supervising physician. The second dose of the first treatment block should contain approximately 8 mg of to about 14 mg for the third dose of the first treatment block, and The dose is increased to a dose selected from 4 mg to about 20 mg, and in the first treatment block The maximum dose is the total dose for all subsequent treatment blocks and the doses within those subsequent treatment blocks. The first, second and third doses in the first treatment block were used as the dose for Useful specific amounts for administration are, for example, about 6 mg, about 12 mg, and about 18 mg. In this particular embodiment, the interval between each administration within the first treatment block is about 3 hours. In the same particular embodiment, the 5-MeO-DMT is administered by inhalation. In one embodiment, the occurrence of a peak psychedelic experience is assessed using the 30-item Revised Mystical Experiences Questionnaire ( The four subscales of the MEQ30 (mystical, positive mood, time-space transcendence, and ineffability) Achievement of at least 60% of the highest possible score on each of the following criteria (Barrett FS, J Ps 2015;29(11):1182-90), or at least 75 of the highest This is identified by achieving a total score on the Psychedelic Experience Questionnaire (PPEQ).

[0135] In a more particular embodiment, the disease to be treated is treatment-resistant major depressive disorder. In the same particular embodiment, the 5-MeO- The dosage of the DMT is selected from about 2 mg to about 8 mg for the first administration, and thereafter the patient is administered Unless the participant has already had a peak psychedelic experience within the treatment block, or the supervising physician Unless it is determined that further dose escalation is inappropriate based on observed side effects, The second administration is at a dose selected from about 8 mg to about 14 mg, and the third administration is at a dose selected from about 1 The dose is increased to a dose selected from 4 mg to about 20 mg. Useful specific amounts for the first, second and third administrations are, for example, about 6 mg, about 12 mg and about 1 In this same particular embodiment, the interval between each administration within each treatment block is about 3 The time between the end of one treatment block and the start of the next was approximately 6 days. In this same particular embodiment, the 5-MeO-DMT is administered by inhalation. In the same particular embodiment, the occurrence of a peak psychedelic experience is determined by the 30-item revised mystical sutra. The four subscales of the Mystical Experience Questionnaire (MEQ30) (mystical, positive mood, time-space transcendence, and Achieving at least 60% of the maximum possible score on each of the Barrett t FS, J Psychopharmacol. 2015;29(11):1182-90), or at least Identified by achieving a Peak Psychedelic Experience Questionnaire (PPEQ) total score of 75. do.

[0136] Embodiment Specific embodiments of the present invention are listed below.

[0137] The present invention relates to the treatment of a patient in the embodiments and claims described herein. 5-Methoxy-N,N-dimethyltryptamine (5MeO-DMT) for use in ) or a pharma- ceutically acceptable salt thereof” to “5-methoxy-N,N-dimethyl Treatment of a patient by administration of 5MeO-DMT or a pharma- ceutical acceptable salt thereof. "method of treatment" is defined by replacing "method of treatment" with "method of treatment" Be recognized.

[0138] The clinical response a) occurs within a specific time point; b) persists until at least a specific time point; or c) "after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof." The embodiments and claims described as existing at a certain time are not to be construed as limiting the scope of other embodiments and claims. Throughout the genus, for example, a) the "last dose" is in fact 5-MeO-DMT or a pharmaceutical and b) the "last administration" is in fact the first administration of a salt thereof that is tolerated by the patient. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof that has been used to experience a peak psychedelic experience 5-MeO-DMT or a pharma- ceutical acceptable salt thereof, may be administered at a higher dose than the first administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. This administration may also be followed by administration of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. It is emphasized that the present invention includes all embodiments and claims.

[0139] Embodiments Relating to Treatment of Major Depressive Disorder 1. Have been diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine (5 -MeO-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. Patients have a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or greater. or a 17-item Hamilton Depression Scale (HAM-D) score of 17 or higher The use according to embodiment 1 or 2, in which the patient suffers from moderate or severe major depressive disorder as indicated by 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 4. Patients have a MADRS score of 35 or more or a HAM-D score of 25 or more. 5-MeO- for use according to embodiment 3, DMT or a pharma- ceutically acceptable salt thereof. 5. For the use according to embodiments 1 to 4, the patient is diagnosed with treatment-resistant major depressive disorder. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9. Administered in a dose or dosage regimen that allows the patient to experience a peak psychedelic experience 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiments 1 to 8. Salt. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical (b) exposing a thin layer of the acceptable salt to thermal energy; and (b) passing air over the thin layer. and producing aerosol particles, 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 27. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological The use of any one of embodiments 1 to 26, occurring within about 2 hours after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in Determined by a MADRS score of 28.10 or less or a HAM-D score of 7 or less Remission of depressive symptoms occurs after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT for use according to embodiments 1 to 27, which occurs within about 2 hours after or a pharma- ceutically acceptable salt thereof. 29. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological The method according to any one of embodiments 1 to 28, wherein the administration of the compound lasts for at least 6 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described above. 30. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 75% improvement in 5-MeO-DMT or pharmacological For the use according to embodiments 1 to 29, the present invention is effective to administer the medicament according to any one of claims 1 to 29 on the 7th day after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 31. The patient is within 7 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. In the eyes, as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less 5-MeO-DM for use according to embodiments 1 to 30 in remission of depressive symptoms T or a pharma- ceutically acceptable salt thereof. 32. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological According to any one of embodiments 1 to 31, the effect of administering the compound of the present invention lasts for at least 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described. 33. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 75% improvement in 5-MeO-DMT or pharmacological The use according to any one of embodiments 1 to 32, which is present 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 34. The patient has been refractory to 5-MeO-DMT or a pharmacologic salt thereof for 14 days after the last dose. On the day 1, the patient was assessed by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use according to embodiments 1 to 33, in a state of remission of depressive symptoms MT or a pharma- ceutically acceptable salt thereof. 35. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological According to any one of embodiments 1 to 34, the effect of administering the compound of the present invention lasts for at least 28 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described. 36. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 75% improvement in 5-MeO-DMT or pharmacological The use according to any one of the preceding embodiments, wherein the 28th day after the last administration of an acceptable salt thereof is present. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 37. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. On the day 1, the patient was assessed by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use according to embodiments 1 to 36, in a state of remission of depressive symptoms MT or a pharma- ceutically acceptable salt thereof. 38. For the use according to embodiments 1 to 37, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 39. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 38. salt. 40. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 38-39. means a pharma- ceutically acceptable salt thereof. 41. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 38 to 40, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 42. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 38 to 41, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 43. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 38 or 42, including administration and a commercially acceptable salt thereof. 44. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than previously administered, the occurrence of a peak psychedelic experience may be delayed by 30 minutes. The four subscales of the revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive mood, time At least 60% of the highest possible score on each of the three dimensions (spatial transcendence and ineffability) % achievement of the Altered States of Consciousness (ASC) Questionnaire (OBN) ) by achieving at least 60% of the highest possible score on the first treatment block. The interval between two doses in the dose group is at least about 1 hour and not more than about 24 hours, and the second and any subsequent doses Subsequent treatment blocks may be administered with 5-MeO-DMT or other drugs administered during the first treatment block. The subsequent treatment block comprises a single administration of the maximum dose of a physiologically acceptable salt thereof, For the use according to embodiments 1 to 37, the treatment block is administered at least about 6 days after the treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 45.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than previously administered, the occurrence of peak psychedelic experiences is reduced. Both were identified by achieving a Peak Psychedelic Experience Questionnaire (PPEQ) total score of 75. and the interval between two administrations in the first treatment block is not less than about 1 hour and not more than about 24 hours. The second and any subsequent treatment blocks are administered 5- A single dose of MeO-DMT or a pharma- ceutical acceptable salt thereof, followed by 1, in which a treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 37.

[0140] Embodiments Relating to Treatment of Persistent Depressive Disorder 1. Have been diagnosed with persistent depressive disorder by a qualified medical professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine for use in the treatment of patients with hemorrhagic fever (5-MeO-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. Patients have a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or greater. or a 17-item Hamilton Depression Scale (HAM-D) score of 17 or higher For the use according to embodiment 1 or 2, in patients suffering from moderate or severe depression as indicated by 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 4. Patients have a MADRS score of 35 or more or a HAM-D score of 25 or more. 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof. 5. The use according to embodiments 1 to 4, wherein the patient is diagnosed with treatment-resistant persistent depressive disorder. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9. Administered in a dose or dosage regimen that allows the patient to experience a peak psychedelic experience 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiments 1 to 8. Salt. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical (b) exposing a thin layer of the acceptable salt to thermal energy; and (b) passing air over the thin layer. and producing aerosol particles, 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 27. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological The use of any one of embodiments 1 to 26, occurring within about 2 hours after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in Determined by a MADRS score of 28.10 or less or a HAM-D score of 7 or less Remission of depressive symptoms occurs after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT for use according to embodiments 1 to 27, which occurs within about 2 hours after or a pharma- ceutically acceptable salt thereof. 29. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological The method according to any one of embodiments 1 to 28, wherein the administration of the compound lasts for at least 6 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described above. 30. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 75% improvement in 5-MeO-DMT or pharmacological For the use according to embodiments 1 to 29, the present invention is effective to administer the medicament according to any one of claims 1 to 29 on the 7th day after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 31. The patient is within 7 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. In the eyes, as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less 5-MeO-DM for use according to embodiments 1 to 30 in remission of depressive symptoms T or a pharma- ceutically acceptable salt thereof. 32. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological According to any one of embodiments 1 to 31, the effect of administering the compound of the present invention lasts for at least 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described. 33. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 75% improvement in 5-MeO-DMT or pharmacological The use according to any one of embodiments 1 to 32, which is present 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 34. The patient has been refractory to 5-MeO-DMT or a pharmacologic salt thereof for 14 days after the last dose. On the day 1, the patient was assessed by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use according to embodiments 1 to 33, in a state of remission of depressive symptoms MT or a pharma- ceutically acceptable salt thereof. 35. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological According to any one of embodiments 1 to 34, the effect of administering the compound of the present invention lasts for at least 28 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described. 36. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment A clinical response, as determined by at least a 75% improvement in 5-MeO-DMT or pharmacological The use according to any one of the preceding embodiments, wherein the 28th day after the last administration of an acceptable salt thereof is present. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 37. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. On the day 1, the patient was assessed by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use according to embodiments 1 to 36, in a state of remission of depressive symptoms MT or a pharma- ceutically acceptable salt thereof. 38. For the use according to embodiments 1 to 37, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 39. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 38. salt. 40. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 38-39. means a pharma- ceutically acceptable salt thereof. 41. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 38 to 40, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 42. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 38 to 41, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 43. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 38 or 42, including administration and a commercially acceptable salt thereof. 44. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 37, which is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 45.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 37. .

[0141] Embodiments Related to Treatment of Anxiety Disorders 1. Patients who have been diagnosed with an anxiety disorder by a qualified professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine (5-Me) for use in the treatment of O-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. Patients have a Beck Anxiety Index (BAI) score of 19 or greater or a Hamilton Anxiety Index (HAI) score of 15 or greater. In one embodiment, the patient suffers from moderate or severe anxiety as indicated by the HAM-A score. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to claim 2. 4. Patients have a history of cardiovascular disease as indicated by a BAI score of 30 or more or a HAM-A score of 24 or more. 5-MeO-DMT or a drug for use according to embodiment 3, A physiologically acceptable salt thereof. 5. For the use according to embodiments 1 to 4, wherein the patient is diagnosed with treatment-resistant anxiety disorder. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9.5-MeO-DMT or its salts are used to induce peak psychedelic experiences in patients 5-MeO for use according to embodiments 1 to 8, administered in an amount or dosage regimen - DMT or a pharma- ceutically acceptable salt thereof. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical exposing a thin layer of the acceptable salt to thermal energy; and b) passing air through the thin layer. For use according to embodiment 19, which is produced by creating aerosol particles. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 27. At least one decrease in BAI or HAM-A scores compared to the respective scores before treatment Clinical response, as determined by at least 50% improvement in 5-MeO-DMT or pharmacologic The use according to any one of embodiments 1 to 26, wherein the administration of the salt occurs within about 2 hours after the last administration of the salt. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. As determined by a BAI score of 28.9 or less or a HAM-A score of 7 or less The remission of anxiety symptoms observed after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof is 5-MeO-DM1 for use according to embodiments 1 to 27, which occurs within about 2 hours after administration of T or a pharma- ceutically acceptable salt thereof. 29. At least one improvement in BAI or HAM-A scores compared to the respective scores before treatment Clinical response, as determined by at least 50% improvement in 5-MeO-DMT or pharmacologic The method according to any one of the preceding claims, wherein the administration of the salt thereof lasts for at least 6 days after the last administration of the salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use. 30. At least an improvement in BAI or HAM-A scores compared to the respective scores before treatment Clinical response, as determined by at least 75% improvement in 5-MeO-DMT or pharmacologic 30. The method according to claim 1, wherein the administration of the salt of said compound is present 7 days after the last administration of said compound. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 31. The patient is within 7 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. Anxiety as determined by a BAI score of 9 or less or a HAM-A score of 7 or less 5-MeO-DMT or A pharma- ceutically acceptable salt thereof. 32. At least one improvement in BAI or HAM-A scores compared to the respective scores before treatment Clinical response, as determined by at least 50% improvement in 5-MeO-DMT or pharmacologic The method according to any one of the preceding claims, wherein the administration of the salt of the compound of the present invention lasts for at least 14 days after the last administration of the salt of the compound of the present invention. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 33. At least one improvement in BAI or HAM-A scores compared to the respective scores before treatment Clinical response, as determined by at least 75% improvement in 5-MeO-DMT or pharmacologic For the use according to any one of embodiments 1 to 32, the method is performed on the 14th day after the last administration of the salt thereof. or a pharma- ceutically acceptable salt thereof. 34. The patient has been refractory to 5-MeO-DMT or a pharmacologic salt thereof for 14 days after the last dose. On the day 1, anxiety as measured by a BAI score of 9 or less or a HAM-A score of 7 or less 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 35. At least one improvement in BAI or HAM-A scores compared to the respective scores before treatment Clinical response, as determined by at least 50% improvement in 5-MeO-DMT or pharmacologic The method according to any one of the preceding claims, wherein the administration of the salt of the compound of the present invention lasts for at least 28 days after the last administration of the salt of the compound of the present invention. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 36. At least one improvement in BAI or HAM-A scores compared to the respective scores before treatment Clinical response, as determined by at least 75% improvement in 5-MeO-DMT or pharmacologic For the use according to any one of embodiments 1 to 35, the method is performed 28 days after the last administration of the salt thereof. or a pharma- ceutically acceptable salt thereof. 37. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. On the day 1, anxiety as measured by a BAI score of 9 or less or a HAM-A score of 7 or less 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 38. For the use according to embodiments 1 to 37, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 39. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 38. salt. 40. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 38-39. means a pharma- ceutically acceptable salt thereof. 41. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 38 to 40, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 42. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 38 to 41, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 43. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 38 or 42, including administration and a commercially acceptable salt thereof. 44. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 37, which is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 45.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 37. .

[0142] Embodiments Related to Treatment of Post-Traumatic Stress Disorder 1. Have been diagnosed with Post-Traumatic Stress Disorder by a qualified professional in accordance with accepted medical practice. 5-Methoxy-N,N-dimethyltryptamine for use in the treatment of patients with hemorrhagic fever (5-MeO-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. The patient completed the Posttraumatic Stress Disorder Clinical Diagnostic Interview Scale for DSM-5 (CAPS-5). Moderate, severe, or extreme external stimuli as indicated by a total score of 23 or more across the 20 severity items. 5-MeO-DMT for use according to embodiment 1 or 2 in patients suffering from post-traumatic stress disorder or a pharma- ceutically acceptable salt thereof. 4. The patient has severe symptoms as indicated by a combined score of 35 or more across the 20 severity items of the CAPS-5. 5-MeO for use according to embodiment 3, in patients suffering from moderate or extreme post-traumatic stress disorder - DMT or a pharma- ceutically acceptable salt thereof. 5. The use according to embodiments 1 to 4, wherein the patient is diagnosed with treatment-resistant post-traumatic stress disorder. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9.5-MeO-DMT or its salts are used to induce peak psychedelic experiences in patients 5-MeO for use according to embodiments 1 to 8, administered in an amount or dosage regimen - DMT or a pharma- ceutically acceptable salt thereof. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical exposing a thin layer of the acceptable salt to thermal energy; and b) passing air through the thin layer. For use according to embodiment 19, which is produced by creating aerosol particles. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 27. A decrease in the total score of the 20 severity items of the CAPS-5 compared to the pretreatment score A clinical response, as determined by at least a 30% improvement, was observed with either 5-MeO-DMT or pharmacological The use according to any one of embodiments 1 to 26, occurring within about 7 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 28. CAPS-5 severity level score of 10 or less on the total score of the 20 severity items The remission of symptoms of post-traumatic stress disorder, which is thought to be caused by the administration of 5-MeO-DMT or a pharmacologic 5 for the uses described in embodiments 1 to 27 occurring within about 7 days after the last administration of the salt. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 29. A decrease in the total score of the 20 severity items of the CAPS-5 compared to the pretreatment score A clinical response, as determined by at least a 30% improvement, was observed with either 5-MeO-DMT or pharmacological According to any one of embodiments 1 to 28, the effect of administering the compound of the present invention lasts for at least 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described. 30. A decrease in the total score of the 20 severity items of the CAPS-5 compared to the score before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological For the use according to embodiments 1 to 29, the present invention is effective to administer the medicament according to any one of claims 1 to 29 on the 7th day after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 31. The patient is within 7 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. In the eyes, the severity of the symptoms is judged to be 10 or less on the total score of the 20 severity items of the CAPS-5. For the use according to embodiments 1 to 30, the patient is in a state of remission of symptoms of post-traumatic stress disorder. or a pharma- ceutically acceptable salt thereof. 32. A decrease in the total score of the 20 severity items of the CAPS-5 compared to the score before treatment A clinical response, as determined by at least a 30% improvement, was observed with either 5-MeO-DMT or pharmacological According to any one of embodiments 1 to 31, the effect of administering the compound of the present invention lasts for at least 21 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described. 33. A decrease in the total score of the 20 severity items of the CAPS-5 compared to the score before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological The use according to any one of embodiments 1 to 32, which is present 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 34. The patient has been refractory to 5-MeO-DMT or a pharmacologic salt thereof for 14 days after the last dose. On the day 1, the total score of the 20 severity items of the CAPS-5 was determined to be 10 or less. For the use according to embodiments 1 to 33, the patient is in a state of remission of symptoms of post-traumatic stress disorder. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 35. A decrease in the total score of the 20 severity items of the CAPS-5 compared with the score before treatment A clinical response, as determined by at least a 30% improvement, was observed with either 5-MeO-DMT or pharmacological According to any one of embodiments 1 to 34, the effect of administering the compound of the present invention lasts for at least 28 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described. 36. A decrease in the total score of the 20 severity items of the CAPS-5 compared with the score before treatment A clinical response, as determined by at least a 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological The use according to any one of the preceding embodiments, wherein the 28th day after the last administration of an acceptable salt thereof is present. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 37. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. On the day 1, the total score of the 20 severity items of the CAPS-5 was determined to be 10 or less. For the use according to embodiments 1 to 36, the patient is in a state of remission of symptoms of post-traumatic stress disorder. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 38. For the use according to embodiments 1 to 37, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 39. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 38. salt. 40. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 38-39. means a pharma- ceutically acceptable salt thereof. 41. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 38 to 40, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 42. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 38 to 41, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 43. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 38 or 42, including administration and a commercially acceptable salt thereof. 44. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 37, which is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 45.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 37. .

[0143] Embodiments Relating to Treatment of Body Dysmorphic Disorder 1. Have been diagnosed with body dysmorphic disorder by a qualified professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine (5- MeO-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. Patients completed the Yale-Brown Obsessive-Compulsive Disorder Scale (Modified for Body Dysmorphic Disorder). Moderate or severe body dysmorphia as indicated by a score of 31 or higher on the BDD-YBOCS 5-MeO-DMT or pharmaceutical agents for use according to embodiment 1 or 2, and its salts which are acceptable to. 4. The patient has severe body dysmorphic disorder as indicated by a score of 41 or greater on the BDD-YBOCS. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to embodiment 3, That salt. 5. For the use according to embodiments 1 to 4, wherein the patient is diagnosed with treatment-resistant body dysmorphic disorder. or a pharma- ceutically acceptable salt thereof. 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9.5-MeO-DMT or its salts are used to induce peak psychedelic experiences in patients 5-MeO for use according to embodiments 1 to 8, administered in an amount or dosage regimen - DMT or a pharma- ceutically acceptable salt thereof. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical exposing a thin layer of the acceptable salt to thermal energy; and b) passing air through the thin layer. For use according to embodiment 19, which is produced by creating aerosol particles. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 27. At least a 30% improvement in the BDD-YBOCS compared to pretreatment scores. The clinical response, as determined by the final 5-MeO-DM for use according to embodiments 1 to 26, occurring within about 7 days after administration T or a pharma- ceutically acceptable salt thereof. 28. Symptoms of body dysmorphic disorder as determined by a score of 16 or less on the BDD-YBOCS remission occurs within about 7 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or pharmacologic agents for use according to embodiments 1 to 27, Acceptable salts thereof. 29. At least a 30% improvement in the BDD-YBOCS compared to pretreatment scores. The clinical response, as determined by the final 5-M for use according to embodiments 1 to 28, which persists for at least 14 days after administration. eO-DMT or a pharma- ceutically acceptable salt thereof. 30. At least a 50% improvement in the BDD-YBOCS compared to pretreatment scores. The clinical response, as determined by the final 5-MeO-DMT or 5-MeO-DMT for use according to embodiments 1 to 29, present on the 7th day after administration or a pharma- ceutically acceptable salt thereof. 31. The patient is within 7 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. In particular, symptoms of body dysmorphic disorder as determined by a score of 16 or less on the BDD-YBOCS 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 30 in remission and a commercially acceptable salt thereof. 32. At least a 30% improvement in the BDD-YBOCS compared to the pretreatment score. The clinical response, as determined by the final 5-M for use according to embodiments 1 to 31, which persists for at least 21 days after administration. eO-DMT or a pharma- ceutically acceptable salt thereof. 33. At least 50% improvement in the BDD-YBOCS compared to pretreatment scores. The clinical response, as determined by the final 5-MeO-DMT for use according to embodiments 1 to 32, present on the 14th day after administration or a pharma- ceutically acceptable salt thereof. 34. The patient has been refractory to 5-MeO-DMT or a pharmacologic salt thereof for 14 days after the last dose. On the day 1, symptoms of body dysmorphic disorder as measured by a score of 16 or less on the BDD-YBOCS 5-MeO-DMT or a drug for use according to embodiments 1 to 33, in a state of remission of A physiologically acceptable salt thereof. 35. At least a 30% improvement in the BDD-YBOCS compared to the pretreatment score. The clinical response, as determined by the final 5-M for use according to embodiments 1 to 34, which persists for at least 28 days after administration. eO-DMT or a pharma- ceutically acceptable salt thereof. 36. At least a 50% improvement in the BDD-YBOCS compared to the pretreatment score. The clinical response, as determined by the final 5-MeO-DMT for use according to embodiments 1 to 35, present on the 28th day after administration or a pharma- ceutically acceptable salt thereof. 37. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. On the day 1, symptoms of body dysmorphic disorder as measured by a score of 16 or less on the BDD-YBOCS 5-MeO-DMT or a drug for use according to embodiments 1 to 36, in a state of remission of A physiologically acceptable salt thereof. 38. For the use according to embodiments 1 to 37, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 39. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 38. salt. 40. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 38-39. means a pharma- ceutically acceptable salt thereof. 41. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 38 to 40, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 42. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 38 to 41, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 43. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 38 or 42, including administration and a commercially acceptable salt thereof. 44. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 37, which is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 45.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 37. .

[0144] Embodiments Relating to Treatment of Obsessive-Compulsive Disorder 1. Have been diagnosed with obsessive-compulsive disorder by a qualified professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine (5-M) for use in treating patients eO-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. The patient has a score of 26 or higher on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The method according to embodiment 1 or 2, wherein the patient suffers from moderate or severe obsessive-compulsive disorder as indicated by the core 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use. 4. The patient suffers from severe obsessive-compulsive disorder as indicated by a total score of 35 or greater on the Y-BOCS. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 3. . 5. For the use according to embodiments 1 to 4, wherein the patient is diagnosed with treatment-resistant obsessive-compulsive disorder. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9.5-MeO-DMT or its salts are used to induce peak psychedelic experiences in patients 5-MeO for use according to embodiments 1 to 8, administered in an amount or dosage regimen - DMT or a pharma- ceutically acceptable salt thereof. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical exposing a thin layer of the acceptable salt to thermal energy; and b) passing air through the thin layer. For use according to embodiment 19, which is produced by creating aerosol particles. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 27. At least a 35% improvement in the YBOCS compared to pretreatment scores. The clinical response observed is approximately 1 hour after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or 5-MeO-DMT for use according to embodiments 1 to 26 occurring within 7 days A pharma- ceutically acceptable salt thereof. 28. Remission of obsessive-compulsive disorder symptoms as measured by a YBOCS score of 12 or less for 5 - Occurring within approximately 7 days after the last dose of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharma- ceutically acceptable That salt. 29. At least a 35% improvement in the YBOCS compared to pretreatment scores. The clinical response observed is at least 10 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-D for use according to embodiments 1 to 28, which lasts for at least 14 days. MT or a pharma- ceutically acceptable salt thereof. 30. At least 50% improvement in the YBOCS compared to pretreatment scores. The clinical response observed is within 7 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 29, and a commercially acceptable salt thereof. 31. The patient is within 7 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. In particular, patients were in remission of obsessive-compulsive disorder symptoms as determined by a score of 12 or less on the YBOCS. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of embodiments 1 to 30. The salt that can be used. 32. At least a 35% improvement in the YBOCS compared to pretreatment scores. The clinical response observed is at least 10 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-D for use according to embodiments 1 to 31, which lasts for at least 21 days. MT or a pharma- ceutically acceptable salt thereof. 33. At least 50% improvement in the YBOCS compared to pretreatment scores. The clinical response observed is 1 day after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or a drug for use according to embodiments 1 to 32 present on the fourth day A physiologically acceptable salt thereof. 34. The patient has been refractory to 5-MeO-DMT or a pharmacologic salt thereof for 14 days after the last dose. On the day 1, obsessive-compulsive disorder symptoms were in remission as measured by a score of 12 or less on the YBOCS. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to any one of embodiments 1 to 33. The salt that will be used. 35. At least a 35% improvement in the YBOCS compared to pretreatment scores. The clinical response observed is at least 10 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-D for use according to embodiments 1 to 34, which lasts for at least 28 days. MT or a pharma- ceutically acceptable salt thereof. 36. At least 50% improvement in the YBOCS compared to pretreatment scores. The clinical response observed is 2 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or a drug for use according to embodiments 1 to 35 present on day 8 A physiologically acceptable salt thereof. 37. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. On the day 1, obsessive-compulsive disorder symptoms were in remission as measured by a score of 12 or less on the YBOCS. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to any one of embodiments 1 to 36. The salt that will be used. 38. For the use according to embodiments 1 to 37, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 39. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 38. salt. 40. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 38-39. means a pharma- ceutically acceptable salt thereof. 41. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 38 to 40, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 42. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 38 to 41, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 43. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 38 or 42, including administration and a commercially acceptable salt thereof. 44. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 37, which is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 45.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 37. .

[0145] Embodiments Relating to Treatment of Anorexia Nervosa 1. Have anorexia nervosa diagnosed by a qualified professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine ( ... 5-MeO-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. The patient has a weight of 17 kg / m 2 Moderate, severe, or extreme obesity as indicated by a body mass index of less than 5-MeO-D for use according to embodiment 1 or 2 in patients suffering from anorexia nervosa of any severity MT or a pharma- ceutically acceptable salt thereof. 4. The patient has a weight of 16 kg / m 2Severe or extreme appetite nervosa as indicated by a body mass index of less than 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to embodiment 3, The salt that will be used. 5. The use of any one of embodiments 1 to 4, wherein the patient is diagnosed with treatment-resistant anorexia nervosa. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9.5-MeO-DMT or its salts are used to induce peak psychedelic experiences in patients 5-MeO for use according to embodiments 1 to 8, administered in an amount or dosage regimen - DMT or a pharma- ceutically acceptable salt thereof. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical exposing a thin layer of the acceptable salt to thermal energy; and b) passing air through the thin layer. For use according to embodiment 19, which is produced by creating aerosol particles. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. At least 1% decrease in body mass index compared to pre-treatment with 27.5-MeO-DMT kg / m 2 A clinical response, as determined by an increase in the The use according to any one of embodiments 1 to 26, occurring within about 28 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 28. At least 18.5kg / m 2 Anorexia nervosa as determined by body mass index remission occurs approximately 56 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 27, and a commercially acceptable salt thereof. At least 1% decrease in body mass index compared to pre-treatment with 29.5-MeO-DMT kg / m 2 A clinical response, as determined by an increase in the The method according to any one of embodiments 1 to 28, wherein the therapeutic effect lasts for at least 56 days after the last administration of the acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described above. At least 1% decrease in body mass index compared to pre-treatment with 30.5-MeO-DMT kg / m 2 A clinical response, as determined by an increase in the For the use according to embodiments 1 to 29, the present invention is effective on the 28th day after the last administration of a tolerable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 31. The patient has been in the 56-month period since the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof At least 18.5 kg / m on the day 2 Anorexia nervosa as determined by body mass index 5-MeO-DMT or A pharma- ceutically acceptable salt thereof. 32. For the use according to embodiments 1 to 31, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 33. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 32. salt. 34. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 32-33. means a pharma- ceutically acceptable salt thereof. 35. The first treatment block included 1 to 7 administrations of the dose at which the patient experienced a peak experience. The use according to any one of embodiments 32 to 34, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 36. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 32 to 35, the administration period being from about 1 hour to about 24 hours MT or a pharma- ceutically acceptable salt thereof. 37. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 32 or 36, and a commercially acceptable salt thereof. 38.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 31, administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 39.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 31. .

[0146] Embodiments Relating to Treatment of Bulimia Nervosa 1. Have been diagnosed with bulimia nervosa by a qualified professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine (5- MeO-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. The patient has moderate or severe binge eating disorder as indicated by 4 or more binge eating episodes per week. 5-MeO-DMT for use according to embodiment 1 or 2 in patients suffering from bulimia nervosa or a pharma- ceutically acceptable salt thereof. 4. Severe bulimia nervosa as indicated by the patient having 8 or more binge eating and vomiting episodes per week 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to embodiment 3, Rusono salt. 5. For the use according to embodiments 1 to 4, wherein the patient is diagnosed with treatment-resistant bulimia nervosa. or a pharma- ceutically acceptable salt thereof. 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9.5-MeO-DMT or its salts are used to induce peak psychedelic experiences in patients 5-MeO for use according to embodiments 1 to 8, administered in an amount or dosage regimen - DMT or a pharma- ceutically acceptable salt thereof. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical exposing a thin layer of the acceptable salt to thermal energy; and b) passing air through the thin layer. For use according to embodiment 19, which is produced by creating aerosol particles. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. Compared to the number of binge eating and vomiting episodes per week before administration of 27.5-MeO-DMT, Clinical outcome as measured by at least a 50% reduction in the number of binge eating and vomiting episodes per week Response occurs within about 7 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmacologic agents for use according to embodiments 1 to 26, Acceptable salts thereof. 28. Symptoms of bulimia nervosa as measured by 0 binge eating and vomiting episodes per week Remission occurs within about 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical compositions for use according to embodiments 1 to 27, and its salts which are acceptable to. Compared to the number of binge eating and vomiting episodes per week before administration of 29.5-MeO-DMT, Clinical outcome as measured by at least a 50% reduction in the number of binge eating and vomiting episodes per week Response is at least 1 day after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or 5-MeO-DMT for use according to embodiments 1 to 28, lasting up to 14 days. means a pharma- ceutically acceptable salt thereof. Compared to the number of binge eating and vomiting episodes per week before administration of 30.5-MeO-DMT, Clinical outcome as determined by at least a 75% reduction in the number of binge eating and vomiting episodes per week The response is present 7 days after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to embodiments 1 to 29. The salt that will be used. 31. The patient has not received any of the following treatments within 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof: Symptoms of bulimia nervosa as measured by 0 binge eating and vomiting episodes per week on the day 5-MeO-DMT or a drug for use according to embodiments 1 to 30, in a state of remission of A physiologically acceptable salt thereof. Compared to the number of binge eating and vomiting episodes per week before administration of 32.5-MeO-DMT, Clinical outcome as measured by at least a 50% reduction in the number of binge eating and vomiting episodes per week Response is at least 1 day after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or 5-MeO-DMT for use according to embodiments 1 to 31, lasting up to 21 days means a pharma- ceutically acceptable salt thereof. Compared to the number of binge eating and vomiting episodes per week before administration of 33.5-MeO-DMT, Clinical outcome as determined by at least a 75% reduction in the number of binge eating and vomiting episodes per week Response is assessed 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to embodiments 1 to 32. The salt is acceptable. 34. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 21 days since the last dose. Symptoms of bulimia nervosa as measured by 0 binge eating and vomiting episodes per week on the day 5-MeO-DMT or a drug for use according to embodiments 1 to 33, in a state of remission of A physiologically acceptable salt thereof. Compared to the number of binge eating and vomiting episodes per week before administration of 35.5-MeO-DMT, Clinical outcome as measured by at least a 50% reduction in the number of binge eating and vomiting episodes per week Response is at least 1 day after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or 5-MeO-DMT for use according to embodiments 1 to 34, lasting up to 28 days. means a pharma- ceutically acceptable salt thereof. Compared to the number of binge eating and vomiting episodes per week before administration of 36.5-MeO-DMT, Clinical outcome as determined by at least a 75% reduction in the number of binge eating and vomiting episodes per week Response is assessed 28 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to embodiments 1 to 35. The salt is acceptable. 37. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. Symptoms of bulimia nervosa as measured by 0 binge eating and vomiting episodes per week on the day 5-MeO-DMT or a drug for use according to embodiments 1 to 36, in a state of remission of A physiologically acceptable salt thereof. 38. For the use according to embodiments 1 to 37, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 39. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 38. salt. 40. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 38-39. means a pharma- ceutically acceptable salt thereof. 41. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 38 to 40, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 42. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 38 to 41, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 43. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 38 or 42, including administration and a commercially acceptable salt thereof. 44. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 37, which is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 45.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 37. .

[0147] Embodiments Relating to Treatment of Binge Eating Disorder 1. Have been diagnosed with binge eating disorder by a qualified professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine (5-M) for use in treating patients eO-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. The patient has moderate or severe binge eating disorder as indicated by 4 or more binge eating episodes per week. 5-MeO-DMT or A pharma- ceutically acceptable salt thereof. 4. The patient suffers from a severe binge eating disorder as indicated by 8 or more binge eating episodes per week. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 3. salt. 5. For the use according to embodiments 1 to 4, wherein the patient is diagnosed with treatment-resistant binge eating disorder. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9. Administered in a dose or dosage regimen that allows the patient to experience a peak psychedelic experience 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiments 1 to 8. Salt. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical exposing a thin layer of the acceptable salt to thermal energy; and b) passing air through the thin layer. For use according to embodiment 19, which is produced by creating aerosol particles. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. The number of binge eating episodes per week after 27.5-MeO-DMT compared to the number of binge eating episodes per week before 27.5-MeO-DMT A clinical response as determined by at least a 50% reduction in the number of binge eating episodes per day. Occurs within approximately 7 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiments 1 to 26. Rusono salt. 28. Remission of binge eating disorder symptoms as measured by 0 binge eating episodes per week Within about 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to embodiments 1 to 27. The salt that will be used. The number of binge eating episodes per week after 29.5-MeO-DMT compared to the number of binge eating episodes per week before 29.5-MeO-DMT A clinical response as determined by at least a 50% reduction in the number of binge eating episodes per day. At least 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or pharmaceutical compositions for use according to embodiments 1 to 28, and its salts which are acceptable to. 30.5-MeO-DMT compared to the number of binge eating episodes per week before treatment A clinical response as determined by at least a 75% reduction in the number of binge eating episodes per day. present 7 days after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof, 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 1 to 29. Salt. 31. The patient has not received any of the following treatments within 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof: Remission of binge eating disorder symptoms as measured by 0 binge eating episodes per week on the day 5-MeO-DMT or pharmacologic agents for use according to embodiments 1 to 30 in the Acceptable salts thereof. 32.5-MeO-DMT compared to the number of binge eating episodes per week before treatment A clinical response as determined by at least a 50% reduction in the number of binge eating episodes per day. At least 21 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or pharmaceutical compositions for use according to embodiments 1 to 31, and its salts which are acceptable to. The number of binge eating episodes per week was reduced compared to the number of binge eating episodes per week before administration of 33.5-MeO-DMT. A clinical response as determined by at least a 75% reduction in the number of binge eating episodes per day. Present 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharma- ceutically acceptable That salt. 34. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 21 days since the last dose. Remission of binge eating disorder symptoms as measured by 0 binge eating episodes per week on the day 5-MeO-DMT or pharmacologic agents for use according to embodiments 1 to 33 in the Acceptable salts thereof. The number of binge eating episodes per week after 35.5-MeO-DMT compared to the number of binge eating episodes per week before 35.5-MeO-DMT A clinical response as determined by at least a 50% reduction in the number of binge eating episodes per day. At least 28 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or pharmaceutical compositions for use according to embodiments 1 to 34, and its salts which are acceptable to. 36.5-MeO-DMT compared to the number of binge eating episodes per week before treatment A clinical response as determined by at least a 75% reduction in the number of binge eating episodes per day. Present 28 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharma- ceutically acceptable That salt. 37. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. Remission of binge eating disorder symptoms as measured by 0 binge eating episodes per week on the day 5-MeO-DMT or pharmacologic agents for use according to embodiments 1 to 36 in the Acceptable salts thereof. 38. For the use according to embodiments 1 to 37, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 39. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 38. salt. 40. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 38-39. means a pharma- ceutically acceptable salt thereof. 41. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 38 to 40, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 42. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 38 to 41, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 43. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 38 or 42, including administration and a commercially acceptable salt thereof. 44. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 37, which is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 45.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 37. .

[0148] Embodiments Related to Treatment of Psychoactive Substance Abuse 1. Have been diagnosed with psychoactive substance abuse by a qualified professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine ( ... 5-MeO-DMT) or a pharma- ceutically acceptable salt thereof. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. The patient meets at least 4 of the 11 DSM-5 diagnostic criteria for substance use disorder. suffer from moderate or severe psychoactive substance abuse as indicated by the presence of refusal criteria; 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to form 1 or 2. salt. 4. The patient meets at least 6 of the 11 DSM-5 diagnostic criteria for substance use disorder. As described in embodiment 3, the patient suffers from severe psychoactive substance abuse as indicated by the presence of refusal criteria. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 5. The use of any one of embodiments 1 to 4, wherein the patient is diagnosed with treatment-resistant psychoactive substance abuse. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 6. 5-MeO-D for use according to embodiments 1 to 5, in which the patient further suffers from suicidal thoughts MT or a pharma- ceutically acceptable salt thereof. 7. 5-M for use as described in embodiment 6, in which the patient suffers from suicidal thoughts with the intention to carry them out. eO-DMT or a pharma- ceutically acceptable salt thereof. 8. 5-M for use according to embodiments 1 to 7, in which the patient is at imminent risk of suicide eO-DMT or a pharma- ceutically acceptable salt thereof. 9.5-MeO-DMT or its salts are used to induce peak psychedelic experiences in patients 5-MeO for use according to embodiments 1 to 8, administered in an amount or dosage regimen - DMT or a pharma- ceutically acceptable salt thereof. 10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5 - In embodiment 1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 9. 12. 5-MeO-DMT or a salt thereof is administered in a first dosage for a first administration, and -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable That salt. 13.5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-1, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to 2. 14. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 6 mg. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 13. 15. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable equivalent thereof for use according to embodiments 12 to 14. Salt. 16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 9 to 15, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 17. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 16, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 18. 5-Me for use according to any of the previous embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 19. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 18. salt. 20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical exposing a thin layer of the acceptable salt to thermal energy; and b) passing air through the thin layer. For use according to embodiment 19, which is produced by creating aerosol particles. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 21. 5-Me for use according to embodiments 18 to 20, used in the form of the free base O-DMT. 22. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 22, and a commercially acceptable salt thereof. 24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 23, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 24, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 25, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 11 DSM-124 for substance use disorder compared to the number prior to administration of 27.5-MeO-DMT - As determined by at least a 50% reduction in the number of diagnostic criteria present out of 5 diagnostic criteria A clinical response is observed within about 7 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 26, and a commercially acceptable salt thereof. 28. 0 of 11 DSM-5 diagnostic criteria for substance use disorders are present Remission from psychoactive substance abuse, as measured by 5-MeO-DMT or pharmacological The use of any one of embodiments 1 to 27, occurring within about 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 11 DSM-124 for substance use disorder compared to the number prior to administration of 29.5-MeO-DMT - As determined by at least a 50% reduction in the number of diagnostic criteria present out of 5 diagnostic criteria A clinical response is at least 1 day after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT for use according to embodiments 1 to 28, both of which last for up to 14 days. or a pharma- ceutically acceptable salt thereof. 11 DSM-124 for substance use disorder compared to 30.5-MeO-DMT pre-treatment count - As determined by at least a 75% reduction in the number of diagnostic criteria present out of 5 diagnostic criteria Clinical response is assessed 7 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmacopoeitic agent for use according to embodiments 1 to 29, Acceptable salts thereof. 31. The patient has not received any of the following treatments within 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof: On the day, 0 of the 11 DSM-5 diagnostic criteria for substance use disorders were present. The method according to any one of embodiments 1 to 30, wherein the patient is in remission from psychoactive substance abuse as determined by 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 11 DSM-13 for substance use disorder compared to 32.5-MeO-DMT pre-treatment counts - As determined by at least a 50% reduction in the number of diagnostic criteria present out of 5 diagnostic criteria A clinical response is at least 1 day after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT for use according to embodiments 1 to 31, both of which last for up to 21 days. or a pharma- ceutically acceptable salt thereof. 11 DSM-13 for substance use disorder compared to 33.5-MeO-DMT pre-treatment counts - As determined by at least a 75% reduction in the number of diagnostic criteria present out of 5 diagnostic criteria Clinical response is assessed 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical agent for use according to embodiments 1 to 32, which is present in the eye and its salts which are acceptable to. 34. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 21 days since the last dose. On the day, 0 of the 11 DSM-5 diagnostic criteria for substance use disorders were present. The method according to any one of embodiments 1 to 33, wherein the patient is in a state of remission from psychoactive substance abuse as determined by 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 11 DSM-13 for substance use disorder compared to the number prior to administration of 35.5-MeO-DMT - As determined by at least a 50% reduction in the number of diagnostic criteria present out of 5 diagnostic criteria A clinical response is at least 1 day after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT for use according to embodiments 1 to 34, both of which last for up to 28 days. or a pharma- ceutically acceptable salt thereof. 11 DSM-124 for substance use disorder compared to 36.5-MeO-DMT pre-treatment count - As determined by at least a 75% reduction in the number of diagnostic criteria present out of 5 diagnostic criteria Clinical response was assessed 28 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical agent for use according to embodiments 1 to 35, which is present in the eye and its salts which are acceptable to. 37. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. On the day, 0 of the 11 DSM-5 diagnostic criteria for substance use disorders were present. The method according to any one of embodiments 1 to 36, wherein the patient is in remission from psychoactive substance abuse as determined by 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 38. For the use according to embodiments 1 to 37, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 39. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 38. salt. 40. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 38-39. means a pharma- ceutically acceptable salt thereof. 41. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 38 to 40, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 42. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 38 to 41, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 43. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 38 or 42, including administration and a commercially acceptable salt thereof. 44. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 37, which is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 45.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 37. .

[0149] Treatment of major depressive disorder with suicidal ideation or imminent risk of suicide Embodiments relating to the arrangement 1. Have been diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practice and diagnosed by a qualified professional in accordance with accepted medical practice. For use in treating patients with suicidal ideation or at imminent risk of suicide. 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or pharmaceutical and its salts which are acceptable to. 2. The disorder is classified as a disorder identified by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM) published by the American Psychiatric Association. -5) 5-MeO-DMT or a drug for use according to embodiment 1, A physiologically acceptable salt thereof. 3. Patients have a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or greater. or a 17-item Hamilton Depression Scale (HAM-D) score of 17 or higher Patients with moderate or severe major depressive disorder as indicated by the Clinical Global Impression Scale-Suicidality Severity Based on the Clinical Geriatrics and Neuropsychiatry - Revised (CGI-SS-R) scale, the following were assessed: moderate suicidality, marked suicidality, severe suicidality, For the use according to embodiment 1 or 2, the patient is considered to have moderate or extreme suicidal tendencies. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 4. Patients have a MADRS score of 35 or more or a HAM-D score of 25 or more. Patients with severe major depressive disorder as indicated by the Clinical Global Impression-Suicidality Severity-Revised ( marked suicidality, severe suicidality, or extreme suicidality based on the CGI-SS-R scale 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to embodiment 3, which is considered to be a therapeutic agent. The salt is acceptable. 5. For the use according to embodiments 1 to 4, the patient is diagnosed with treatment-resistant major depressive disorder. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 6.5-MeO-DMT or its salts are used to induce peak psychedelic experiences in patients 5-MeO for use according to embodiments 1 to 5, administered in an amount or dosage regimen - DMT or a pharma- ceutically acceptable salt thereof. 7. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or In embodiments 1 to 6, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of O-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described. 8. A dose of about 6 mg or about 12 mg or about 18 mg is administered, or 5- In embodiments 1 to 4, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of MeO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to claim 6. 9. 5-MeO-DMT or a salt thereof is administered in a first dosage for the first administration, and 5- MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being administered to the patient. Use a higher dosage than the previous dose unless you experience a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiments 1 to 7. salt. 10. 5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg; The second dose is then approximately 8 mg unless the patient has already experienced a peak psychedelic experience. ~The dose is increased to approximately 14mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 14 mg to about 20 mg, or 5-M In embodiments 1-9, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in claim 1. 11. The first dose of 5-MeO-DMT was approximately 6 mg, and the second dose of 5-MeO-DMT was approximately 1. and the third dose of 5-MeO-DMT is about 18 mg. Alternatively, an equimolar amount of a pharma- ceutically acceptable salt is administered in place of 5-MeO-DMT. 11. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to embodiment 10. 12. The interval between two doses is 1 hour or more and 24 hours or less, for example, about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiments 9 to 11. salt. 13. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30 ) of its four subscales (mystical, positive mood, transcendence of time and space, and ineffability). Identified by achieving at least 60% of the highest possible score in each, or A maximum possible score of at least 6 on the Ocean Feeling (OBN) aspect of the Altered States of Consciousness (ASC) questionnaire Identified by achieving 0% or at least 75 peak psychedelic experience questions Use according to embodiments 6 to 12, as determined by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for 14. The occurrence of a peak psychedelic experience is determined by completing at least 75 Peak Psychedelic Experience Questions. For the use according to embodiment 13, as identified by the achievement of a total score on the PPEQ. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis. 15. 5-Me for use according to any of the preceding embodiments, administered by inhalation O-DMT or a pharma- ceutically acceptable salt thereof. 16. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) pharma- ceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or or a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 15. salt. 17. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical exposing a thin layer of the acceptable salt to thermal energy; and b) passing air through the thin layer. For use according to embodiment 16, produced by creating aerosol particles. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 18. 5-Me for use according to embodiments 15 to 17, used in the form of the free base O-DMT. 19. The patient receives a single dose of 5-MeO-DMT or a pharma- ceutical acceptable salt. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 20. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement Clinical improvement as determined by a score of at least "marked improvement" on the Prostate Cancer Indicator-Improvement Indicator (PGI-I) score. The bed response occurs within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or pharmaceutical composition for use according to embodiments 1 to 19, and a commercially acceptable salt thereof. 21. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 20, the method of claim 1, wherein the method of claim 1, wherein the method of claim 2 ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 22. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 21, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 23. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response as determined by the method of claim 1 is determined by administering 5-MeO-DMT or a pharma- ceutical acceptable salt thereof to a subject. For the use according to any one of embodiments 1 to 22, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 24. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined is determined based on the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT for use according to embodiments 1 to 23, which occurs within about 2 hours after or a pharma- ceutically acceptable salt thereof. MADRS score of 25.10 or less or HAM-D score of 7 or less, and CGI-S This is determined by a score on the SR scale that indicates either no suicidal tendencies or possible suicidal tendencies. Remission of depressive symptoms and suicidal ideation was observed in patients receiving 5-MeO-DMT or a pharmacologic acceptable equivalent. 5- for the use according to embodiments 1 to 24, occurring within about 2 hours after the last administration of the salt. MeO-DMT or a pharma- ceutically acceptable salt thereof. 26. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined is determined based on the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO- for use according to embodiments 1 to 25, which persists for at least 6 days after DMT or a pharma- ceutically acceptable salt thereof. 27. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment ≥ 75% improvement and at least a 2-level reduction in the CGI-SS-R scale. The clinical response determined is determined based on the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or A pharma- ceutically acceptable salt thereof. 28. The patient is within 7 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. For the eyes, MADRS score of 10 or less or HAM-D score of 7 or less, and CGI-S This is determined by a score on the SR scale that indicates either no suicidal tendencies or possible suicidal tendencies. 5. For use according to embodiments 1 to 27, in a state of remission of depressive symptoms and suicidal thoughts -MeO-DMT or a pharma- ceutically acceptable salt thereof. 29. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined is determined based on the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO for use according to embodiments 1 to 28, which persists for at least 14 days after - DMT or a pharma- ceutically acceptable salt thereof. 30. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment ≥ 75% improvement and at least a 2-level reduction in the CGI-SS-R scale. The clinical response determined is determined based on the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 31. The patient has not received any of the following treatments within 14 days after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof: On the day 1, a MADRS score of 10 or less or a HAM-D score of 7 or less, and a CGI- As determined by a score on the SS-R scale indicating no or suspected suicidal tendencies, For the use according to embodiments 1 to 30, 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 32. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined is determined based on the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO for use according to embodiments 1 to 31, which persists for at least 28 days after - DMT or a pharma- ceutically acceptable salt thereof. 33. A decrease in MADRS or HAM-D scores compared to the respective scores before treatment ≥ 75% improvement and at least a 2-level reduction in the CGI-SS-R scale. The clinical response determined is determined based on the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or means a pharma- ceutically acceptable salt thereof. 34. The patient has been in the 5-MeO-DMT or pharma- ceutical acceptable salt form for 28 days since the last dose. On the day 1, a MADRS score of 10 or less or a HAM-D score of 7 or less, and a CGI- As determined by a score on the SS-R scale indicating no or suspected suicidal tendencies, For the use according to embodiments 1 to 33, 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 35. For the use according to embodiments 1 to 34, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 36. A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable form thereof for use according to embodiment 35. salt. 37. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 22 or 5-MeO-DMT or its salts for use according to embodiments 35-36. means a pharma- ceutically acceptable salt thereof. 38. The first treatment block included 1 to 7 doses of the dose at which the patient experienced the peak experience. The use according to any one of embodiments 35 to 37, wherein the interval between each administration is from about 1 hour to about 24 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 39. Each treatment block contains 1 to 7 administrations, with approximately 1 hour between each administration within each treatment block. 5-MeO-D for use according to embodiments 35 to 38, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 40. The second and any subsequent treatment blocks are administered during the first treatment block. -One or more doses of maximum doses of MeO-DMT or a pharma- ceutical acceptable salt thereof 5-MeO-DMT or a pharmaceutical composition for use according to embodiment 35 or 39, including administration and a commercially acceptable salt thereof. 41. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof was administered in two or more treatment blocks. In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. The 30-item Revised Mystical Experiences Questionnaire (MEQ30) included four subscales (mystical, positive mood, At least the highest possible score on each of the following dimensions (intelligibility, timelessness, and ineffability) Also, the altered states of consciousness (ASC) questionnaire is used to identify patients who have a high level of consciousness. Identified by achieving at least 60% of the highest possible score on the OBN (obstetrics and neuropsychiatric disorder) facet, the first treatment The interval between two doses in a block is at least about 1 hour and not more than about 24 hours, and the second and any Any subsequent treatment block may be administered using 5-MeO-DMT or or a pharma- ceutically acceptable salt thereof, with subsequent treatment blocks comprising The use of any one of embodiments 1 to 34, which is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 42.5-MeO-DMT or a pharma- ceutical acceptable salt thereof in two or more treatment blocks In the first treatment block, 5-MeO-DMT or a salt thereof is administered. The first dose is administered, and 5-MeO-DMT or a salt thereof is administered at 0.5 mg / kg in the first treatment block. Administered in ~6 subsequent doses, each subsequent dose increases the likelihood that the patient will experience a peak psychedelic experience. Unless a higher dosage is used than in the previous dose, the occurrence of a peak psychedelic experience may be delayed. By achieving a Peak Psychedelic Experiences Questionnaire (PPEQ) total score of at least 75. and the interval between two administrations in the first treatment block is greater than or equal to about 1 hour and greater than or equal to about 24 hours. and the second and any subsequent treatment blocks are administered during the first treatment block. a single administration of a maximum dose of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof, A subsequent treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 34. . EXAMPLES

[0150] The following examples are included to aid in the understanding of the present invention and are intended to provide a basis for the appended claims. It is not intended to, and should not be construed as, limiting the invention described in the accompanying claims in any manner whatsoever. It shouldn't be.

[0151] [Example 1] [Example 1A] Administration of 5-MeO-DMT via inhalation Volcano Medic Vaporization System Volcano Medic Vaporization System(Storz 5-MeO-DM was dissolved in water and the drug was evaporated using a 5-MeO-DMPO solution (Bickel, Germany). The device consisted of a hot air generator and a device from which the patient could blow the aerosol. The hot air generator can be adjusted between about 40℃ and about 210℃. The device can produce a temperature of up to 120°C and an air flow rate of approximately 12 liters per minute. The center part of the figure shows the dosing cap into which the appropriate dose of 5-MeO-DMT in ethanol solution is applied. The capsule is then applied to the filling chamber of the device, where it is heated by hot air. The dosing capsule is made of tightly packed stainless steel wire mesh (Drip The capsules contain small disks made of a drug substance (called capsule pads or liquid pads). The bottom and lid of the capsule have holes that allow airflow through the dosage capsule. The dosage capsules and drip pads were measured using the following formula based on measurements of 10 sample capsules: Features:

[0152] [Table 1]

[0153] 5-MeO-DMT aerosol generation and administration Step 1: A target dose of 5-Me is administered to volunteers or patients by inhalation. in 100% ethanol so that O-DMT free base is contained in a solution volume of 200 μl. A stock solution of 5-MeO-DMT free base is prepared in a volumetric flask. The recommended dose is 1 mg to 25 mg of 5-MeO-DMT. For the target dose of eO-DMT, 50 mg of 500 mg was added to give a final solution volume of 1 ml. Dissolve -MeO-DMT in 100% ethanol. Then aliquot the stock solution. may be stored in the vial until further use.

[0154] Step 2: Place 200 μl of solution into a dosing capsule (Storz & Bickel, Germany) and the dosing capsules are closed with caps.

[0155] Step 3: The dosage capsule filled with the ethanolic solution of 5-MeO-DMT is heated at 55° C. The first Volcano Medic Vapor was preheated to a temperature set at The vaporizer airflow is then adjusted to a preset rate of approximately 12 L / min. Turn on the device at 35°C for 60 seconds. Heated air flows through the dosing capsule, discharging ethanol. The ethanol evaporates and the targeted dose of 5-MeO-DMT coats the stainless steel wire mesh. The correct preparation of the dosage capsules is based on the weight of the empty capsule. The final weight gain of the capsules compared was approximately equal to the target dose of 5-MeO-DMT. This can be confirmed by verifying the authenticity of the document.

[0156] Step 4: The prepared dosage capsule is removed from the filling chamber. The cells were then placed in a second Volcano Medi, which had been preheated to a temperature set at 210°C. c Transfer to the Vaporizer's charging chamber and turn on the airflow for at least 5 minutes. The valved suction balloon (Storz & Bickel, Germany) was filled. Attach it to the socket of the chamber, seal the filling chamber, and immediately afterwards increase the air flow to approximately 12 L / This turns the 5-MeO - The entire dose of DMT is aerosolized and dispersed in approximately 3 liters of air within the inhalation balloon. Accurate aerosolization of 5-MeO-DMT requires that the capsule weight is approximately its starting weight. This can be confirmed by demonstrating a return to normal levels.

[0157] Step 5: The valve then closes automatically by removing the balloon from the filling chamber. Once the balloon is fitted with a nozzle, the aerosol can be administered immediately to a volunteer or patient. This will result in a state where

[0158] Step 6: In preparation for administration, ask the patient to take one or two deep breaths and then exhale completely. Ask them to finish by exhaling deeply. Then, place the nozzle firmly against your lips and The entire volume is inhaled completely in one inhalation, the breath is held for 10 (± 2.5) seconds, and then exhaled naturally. After completing the inhalation procedure, instruct the patient to lie down.

[0159] [Example 1B] Loading of 5-MeO-DMT into Dosing Capsules and Determination of Aerosolized Dose 5-MeO-DMT samples stored in 200 μl aliquots in single-use vials A tock solution was used to administer the drug containing target doses of 2 mg and 18 mg of 5-MeO-DMT. Triplicates of drug capsules were prepared as described in steps 1-3 of Example 1A. To ensure that the correct dose of 5-MeO-DMT was loaded into the dosage capsule, Subtract the baseline weight of the empty capsule from the weight of the capsule after step 3 and measure the 5-MeO -Approximately 94% of the target dose of DMT was loaded into the capsules, with only minimal variability This was confirmed (Example 1B, Table 1). The fact that 100% of the target dose was not achieved , a vial used to store 5-MeO-DMT stock solution (approximately 2 μl volume remaining) loss of material during the transfer of the solution from the vial to the capsules, This could be explained by further losses in the pipette tip. This can be prevented by dispensing from a larger volume stock solution and optimizing the dispensing technique. It is possible.

[0160] Next, 5-M is extracted from the dosing capsule as described in steps 4 and 5 of Example 1A. eO-DMT was aerosolized. Accurate aerosolization of 5-MeO-DMT from a dosing capsule. To confirm the solubility, subtract the weight after step 4 from the weight after step 3 and calculate the loading weight. It was determined that 96%-100% of the dose was aerosolized (Example 1B, Table 1).

[0161] [Table 2]

[0162] The dosage capsules were weighed before and after the formation of the 5-MeO-DMT layer to determine the 5-MeO- Instead of determining the loading of a target dose of DMT into a dosing capsule, the loading can alternatively be determined by The amount may also be determined by extracting the drug from the capsule and measuring analytically.

[0163] The capsules were weighed before and after the formation of the 5-MeO-DMT layer and again after aerosolization. To determine the extent to which a target dose of 5-MeO-DMT can be aerosolized from a capsule, Alternatively, an aerosol containing 5-MeO-DMT was delivered to a closed chamber. Analyze the amount of 5-MeO-DMT collected in the chamber by measuring 5-MeO- The released dose of DMT can also be determined.

[0164] [Example 1C] 5-MeO-DMT layer thickness A layer of 5-MeO-DMT covering a stainless steel wire mesh after evaporation of the ethanol solvent. The thickness can be calculated as follows: 5-MeO-DMT layer thickness (μm)=5- Loading dose of MeO-DMT (mg) / [density of 5-MeO-DMT (mg / cm 3 )×Wa Ear surface area (cm 2 )] * 10000. The surface area of ​​the wire is the length of the wire (measured or can be calculated from the weight of the wire mesh) and the diameter of the wire (Can be measured) and can be calculated based on.

[0165] For the dosage capsule prepared in Example 1B, the following layer thicknesses were determined:

[0166] [Table 3]

[0167] At a target loading dose of 2 mg, 37.78 cm 2 Based on the average wire surface area of ​​5-MeO -The thickness of the DMT layer can be calculated to be 0.48 μm, and at a target loading dose of 20 mg, The thickness of the 5-MeO-DMT layer can be calculated to be 4.8 μm.

[0168] [Example 1D] Determination of the rate of formation of aerosol particles and the mass density of aerosol 5-MeO-DMT The rate of formation of aerosol particles can be calculated as follows: Aerosolization rate = aerosolized dose / aerosolization time. Data for aerosolized dose from Example 1B With this data and an aerosolization time of 15 seconds, the following rates of formation of aerosol particles were determined: Ta:

[0169] [Table 4]

[0170] At a target aerosolized dose of 2 mg and an aerosolization time of 15 seconds, the aerosolized particles The formation rate of 0.13 mg / sec can be calculated for a target aerosolized dose of 20 mg. and an aerosolization time of 15 seconds, the particle formation rate is calculated to be 1.33 mg / sec. This can be done.

[0171] The mass density of the aerosol 5-MeO-DMT can be calculated as follows: Mass density of aerosolized 5-MeO-DMT = aerosolized dose / aerosol volume. Example 1B With aerosolized dose data from and an aerosol volume of approximately 3 liters, the following air The mass density of the 5-MeO-DMT solution was determined:

[0172] [Table 5]

[0173] At a targeted aerosolized dose of 2 mg in 3 liters, the quality of aerosolized 5-MeO-DMT The mass density can be calculated to be 0.66 mg / l, giving a target aerosol concentration of 20 mg in 3 liters. For the 5-MeO-DMT aerosolized dose, the mass density of the aerosolized 5-MeO-DMT is calculated to be 6.66 mg / L. At a target aerosolized dose of 2 mg in 2 liters, aerosolized 5-MeO The mass density of DMT can be calculated to be 1 mg / l, giving 20 mg of target enzyme in 2 liters. For the aerosolized dose, the mass density of the aerosolized 5-MeO-DMT is calculated to be 10 mg / l. It is possible.

[0174] [Example 1E] HPLC assay for determination of purity of 5-MeO-DMT An HPLC assay was developed to allow for the determination of the purity of 5-MeO-DMT. The assay was tested for linearity and precision. Based on the results, the method was deemed fit for purpose. It was done.

[0175] The following method parameters were used:

[0176] [Table 6]

[0177] [Table 7]

[0178] Testing the Linearity of the HPLC Method: A stock solution of 5-MeO-DMT was prepared in methanol. Nominal concentrations were obtained.

[0179] [Table 8]

[0180] Linearity of the HPLC method The Y-intercept % of the nominal concentration was calculated to be 0.8%. The method is considered to be linear. Testing the precision of the HPLC method:

[0181] Six sample solutions were prepared at nominal concentrations (12–18 mg in 100 ml methanol). The results were as follows:

[0182] [Table 9]

[0183] The acceptance criteria for purity values ​​between the six samples was 1% RSD, with the actual reading being 0.07%. Therefore, the analytical method is considered to exhibit adequate precision.

[0184] [Example 1F] Assessment of 5-MeO-DMT aerosol purity and degradation products A stock solution of 180.7 mg of 5-MeO-DMT free base in 2 ml of ethanol ( 90.4mg / ml) was used, and 200μl of it was distributed to the drip pad inside the capsule. Separate 18 mg of 5-MeO-DMT as described in steps 1-3 of Example 1A. Duplicate dose capsules were prepared containing the target dose of 5- The purity of the MeO-DMT starting material was 99.605% with only minor proportions of three impurities. (Example 1F, Table 1).

[0185] [Table 10]

[0186] Next, except for using only one Volcano Medic Vaporizer, and dissolving the 5-MeO- in a dosing capsule as described in steps 4 and 5 of Example 1A. DMT was aerosolized (i.e., the vaporizer in step 3 and step 4 was the same). Preheating between capsule preparation and aerosol generation was performed according to the manufacturer's instructions. ).

[0187] For aerosol purity analysis, each of the replicate valve balloons containing aerosol was analyzed using S olid Phase Extraction (SPE) cartridges (Discove The balloon was then connected to a suction tube (DSC-18). A blank was applied. Four aliquots of 5 ml of methanol were added to the cartridge to obtain the extract. Extract 1 was further diluted to achieve a linear range response. The solution was further diluted (1ml to 10ml).

[0188] For Replicate 1, Extract 1 (Example 1F, Table 1), the purity of the aerosol was the same as that of the starting material. The concentration is higher than that of existing impurities (99.710% vs. 99.605%), 3 was undetectable, while the existing impurity 1 increased only minimally (0.206%v s.0.099%), and only minimal amounts of new 5-MeO-DMT degradation products were generated (min. Degradation product 1: 0.039%, Degradation product 2: 0.044%), 5-MeO-D in aerosol The total percentage of MT degradation products was 0.19% (including the additional amount of impurity 1). The results of other replicates were similar, and the results of other extracts would not have altered the conclusions. I didn't understand.

[0189] [Table 11]

[0190] In conclusion, based on the methods and compositions described herein, only minimal amounts of degradation products were observed. It is possible to generate a high purity aerosol containing

[0191] [Example 1G] Preparation of starting materials 5-MeO-DMT (2.0 g) in MTBE (4 mL, 2.0 vol) at 35-40 °C After stirring for 50 minutes at room temperature, crystallization was observed. The batch temperature was lowered to 7-12°C over 30 minutes. Stir at 7-12°C for 10 minutes. Upon stirring, crystallization occurred. The batch was then filtered following stirring for 1 hour at 7-12°C. After washing with MTBE (1 mL, 0.5 vol) at 7–12 °C, the batch was pumped under vacuum for 3.5 h. The solid was dried to give 1.02 g of a pale orange solid (50% recovery). It was therefore analyzed for purity, which was found to be 99.74 area %.

[0192] The table below shows the impurity profile of the isolated material.

[0193] [Table 12]

[0194] The results of the analysis showed an increase in the overall purity of the material, with RRT1.18 and RRT1.2 It was shown that the impurity of 4 was removed to less than 0.10%. The impurity of RRT2.38 was also The NMT was reduced to below the target of 0.10%.

[0195] Solvent analysis of the sample revealed an MTB of 17 ppm, compared to the expected limit of NMT 5000 ppm. E levels were indicated.

[0196] [Example 2] 5-MeO-DMT administered by inhalation to patients with treatment-resistant major depressive disorder Clinical trials Research design: A clinical trial was conducted to evaluate the efficacy and safety of 5-MeO- The aim of the study was to determine the efficacy and safety of 5-MeO-DMT in patients with rheumatoid arthritis. Safety and tolerability of daily doses, dose-related psychedelic effects, and various measures of depression The study was conducted in accordance with the guidelines of the appropriate national competent authorities and local pharmaceutical authorities. The study was reviewed and approved by the Institutional Ethics Committee. Patients recruited for the study were single-episode or Recurrent major depressive disorder (DSM-5) 5) The diagnostic criteria must be met and the condition must be treatment-resistant. Both aspects must be evaluated by a psychiatrist or The participants were evaluated by a clinical psychologist. Patients who were taking such medications or substances should discontinue such medications or substances and discontinue them before administering 5-MeO-DMT. A single dose of 12 mg of 5-MeO-DMT was administered on the day of administration. The patient was administered a single inhalation as described in Example 1A. After administration, the patient was monitored for 3.5 hours. Patients were closely monitored with additional follow-up visits 1 and 7 days after dosing. Various safety-related indicators (e.g., adverse event reports, safety laboratory analyses, vital signs, Signs, electrocardiogram (ECG), Clinical Diagnostic Interview Dissociative Status Scale (CADSS), psychomotor vigilance test Psychedelic Effects Test (PVT, Digit Symbol Substitution Test (DSST)), and indices of the strength of the psychedelic effect (e.g. For example, the Peak Psychedelic Experiences Questionnaire (PPEQ), the Altered States of Consciousness Questionnaire (ASC), The Psychedelic Experience Questionnaire (MEQ30), a subjective description of psychedelic experiences, and depression severity Indicators (Montgomery-Asberg Depression Rating Scale (MADRS), Patient Global Impression - Patient Global Impression-Improvement Scale (PGI-S), Patient Global Impression-Improvement Scale (PGI-I)) and Additional psychological measures (e.g., Columbia-Suicide Severity Rating Scale (C-SSRS), Brief Self-Assessment Scale (SBAS) Patients were monitored by a psychologist throughout the study. and / or psychiatric support was available, but specific psychological therapies were not appropriate. No psychoactive medications were used and no additional psychoactive medications were provided.

[0197] Patient characteristics: Two patients were diagnosed with major depressive disorder by a psychiatrist according to the DSM-5 diagnostic criteria. Patients were recruited into the study (Example 2, Table 1). Patients were taking medication for their current depressive episode. Treatment was discont...

Claims

1. Have been diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practice 5-Methoxy-N,N-dimethyltryptamine (5-M) for use in treating patients eO-DMT) or a pharma- ceutically acceptable salt thereof.

2. The disorder is classified as a disorder identified in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSA), published by the American Psychiatric Association. 5-MeO-DMT or a drug for use according to claim 1, which is diagnosed according to A physiologically acceptable salt thereof.

3. The patient has a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or greater. or a 17-item Hamilton Rating Scale for Depression (HAM-D) score of 17 or higher 3. The use according to claim 1 or 2, in a patient suffering from moderate or severe major depressive disorder as indicated by 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for

4. The patient is characterized by a MADRS score of 35 or greater, or a HAM-D score of 25 or greater. 5-MeO for use according to claim 3, in a patient suffering from a severe major depressive disorder as indicated by - DMT or a pharma- ceutically acceptable salt thereof.

5. The method according to claims 1 to 4, wherein the patient is diagnosed with treatment-resistant major depressive disorder. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis.

6. 5-MeO-D for use according to claims 1 to 5, wherein the patient further suffers from suicidal thoughts. MT or a pharma- ceutically acceptable salt thereof.

7. 5-M for use according to claim 6, wherein the patient suffers from suicidal ideation with the intention to carry it out. eO-DMT or a pharma- ceutically acceptable salt thereof.

8. 5-M for use according to claims 1 to 7, wherein the patient is at imminent risk of suicide. eO-DMT or a pharma- ceutically acceptable salt thereof.

9. 5-MeO-DMT or a salt thereof causes the patient to experience a peak psychedelic experience. 5-MeO for use according to claims 1 to 8, administered in a dose or dosage regimen. - DMT or a pharma- ceutically acceptable salt thereof.

10. A dose of about 4 mg to about 20 mg of 5-MeO-DMT is administered, or - according to claims 1 to 9, wherein an equimolar amount of a pharma- ceutically acceptable salt is administered instead of DMT 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in

11. A dose of about 6 mg, about 12 mg, or about 18 mg is administered, or 5-M The method according to claims 1 to 9, wherein an equimolar amount of a pharma- ceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described.

12. 5-MeO-DMT or a salt thereof is administered in a first dosage for the first administration, and 5-MeO-DMT or a salt thereof is administered in a first dosage for the first administration. eO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being Use a higher dosage than the previous dose unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable derivative thereof for use according to claims 1 to 10. Salt.

13. 5-MeO-DMT is administered in a first dose of about 2 mg to about 8 mg, The second dose is about 8 mg unless the patient has already experienced a peak psychedelic experience. to about 14 mg, after which the patient is already experiencing a peak psychedelic experience. For the third dose, the dose is increased to about 14 mg to about 20 mg unless otherwise specified, or -MeO-DMT is replaced by an equimolar amount of a pharma- ceutically acceptable salt.

13. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to claim 12.

14. The first dose of 5-MeO-DMT was about 6 mg and the second dose of 5-MeO-DMT was about 10 mg. the third dose of 5-MeO-DMT is about 18 mg; and is administered in an equimolar amount of a pharma- ceutically acceptable salt instead of 5-MeO-DMT.

14. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to claim 13.

15. The interval between two administrations is from 1 hour to 24 hours, for example about 2 to 4 hours. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of 12 to 14.

16. The occurrence of peak psychedelic experiences was assessed using the 30-item revised Mystical Experiences Questionnaire (MEQ30). Each of the four subscales (mystical, positive mood, transcendence of time and space, and ineffability) or degeneration, as identified by the achievement of at least 60% of the highest possible score in At least 60% of the maximum possible score on the Oceanic Feeling (OBN) aspect of the ASC questionnaire or at least 75 percentiles on the Peak Psychedelic Experience Questionnaire ( For the use according to claims 9 to 15, characterized by the achievement of a total score of PPEQ. or a pharma- ceutically acceptable salt thereof.

17. The occurrence of peak psychedelic experiences was assessed using at least 75 Peak Psychedelic Experiences Questionnaire ( 5 for the use according to claim 16, as determined by the achievement of a total score of 50.0001 PPEQ. -MeO-DMT or a pharma- ceutically acceptable salt thereof.

18. The 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered by inhalation. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to any one of claims 1 to 17. The salt that can be used.

19. The 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is (a) a pharma- ceutically acceptable salt thereof (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or The drug is administered in the form of an aerosol containing aerosol particles of a pharma- ceutically acceptable salt thereof, The aerosol has a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to claim 18. 。

20. The aerosol comprises: a) 5-MeO-DMT or a pharmaceutical b) exposing a thin layer of the acceptable salt to thermal energy; and c) blowing air over the thin layer.

20. The method of claim 19, wherein the aerosol particles are generated by passing the aerosol through 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in treating or preventing the onset of inflammatory bowel disease.

21. Use according to claims 18 to 20, wherein 5-MeO-DMT is used in the form of the free base. 5-MeO-DMT for.

22. The dosage of 5-MeO-DMT or a pharma- ceutically acceptable salt administered to the patient is 5-MeO-DMT or 5-MeO-DMT for use according to claims 18 to 21, which is inhaled in one breath. or a pharma- ceutically acceptable salt thereof.

23. Clinical Global Impression-Improvement (CGI-I) score or Patient Global Impression-Improvement ( Clinical response as determined by a score of at least "marked improvement" on the PGI-I score The answer is within about 2 hours after the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or a pharma- ceutical acceptable salt thereof for use according to claims 1 to 22, The salt is acceptable.

24. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response determined by the method is 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 5 for the use according to claims 1 to 23, which lasts for at least 6 days after the last administration of -MeO-DMT or a pharma- ceutically acceptable salt thereof.

25. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response determined by the method is 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. for the use according to claims 1 to 24, wherein the effect lasts for at least 14 days after the last administration of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof.

26. At least a "marked improvement" score on the CGI-I or PGI-I score The clinical response determined by the method is 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. for the use according to claims 1 to 25, wherein the effect lasts for at least 28 days after the last administration of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof.

27. At least one decrease in MADRS or HAM-D score compared with the respective score before treatment A clinical response, as determined by at least a 50% improvement in the efficacy and safety of 5-MeO-DMT or a pharmacologic agent that is pharmacologic The method according to any one of claims 1 to 26, wherein the administration of the salt occurs within about 2 hours after the last administration of the salt. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the treatment of osteoarthritis.

28. Depression as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less Remission of symptoms occurs approximately 5 minutes after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. 5-MeO-DMT or A pharma- ceutically acceptable salt thereof.

29. At least one decrease in MADRS or HAM-D score compared with the respective score before treatment The clinical response, as determined by at least a 50% improvement in the clinical outcome, is determined by the administration of 5-MeO-DMT or a pharmacological 29. The method according to claim 1, wherein the effect lasts for at least 6 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in

30. At least one decrease in MADRS or HAM-D score compared with the respective score before treatment A clinical response, as determined by at least a 75% improvement in 5-MeO-DMT or pharmacologic 5. The method according to claim 1, wherein the 5-amino-2-phenyl-2-propanol is administered on the 7th day after the last administration of the salt thereof. -MeO-DMT or a pharma- ceutically acceptable salt thereof.

31. The patient is administered 5-MeO-DMT or a pharma- ceutical acceptable salt thereof 7 days after the last administration. In the eye, as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less 5-MeO-DMT for use according to claims 1 to 30 in remission of depressive symptoms or a pharma- ceutically acceptable salt thereof.

32. At least one decrease in MADRS or HAM-D score compared with the respective score before treatment The clinical response, as determined by at least a 50% improvement in the clinical outcome, is determined by the administration of 5-MeO-DMT or a pharmacological 32. The method according to claim 1, wherein the therapeutic effect lasts for at least 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described above.

33. At least one decrease in MADRS or HAM-D score compared with the respective score before treatment A clinical response, as determined by at least a 75% improvement in 5-MeO-DMT or pharmacologic 33. The method according to claim 1, wherein the administration of the salt thereof is performed 14 days after the last administration of the salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof.

34. The patient is 14 days after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. On the day 1, the patient was assessed by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-DM1 for use according to claims 1 to 33, in a state of remission of depressive symptoms T or a pharma- ceutically acceptable salt thereof.

35. At least one decrease in MADRS or HAM-D score compared with the respective score before treatment The clinical response, as determined by at least a 50% improvement in the clinical outcome, is determined by the administration of 5-MeO-DMT or a pharmacological 35. The method according to claim 1, wherein the therapeutic effect lasts for at least 28 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described above.

36. At least one decrease in MADRS or HAM-D score compared with the respective score before treatment A clinical response, as determined by at least a 75% improvement in 5-MeO-DMT or pharmacologic 36. The method according to claim 1, wherein the medicament is administered 28 days after the last administration of the salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof.

37. The patient is 28 days after the last administration of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof. On the day 1, the patient was assessed by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-DM1 for use according to claims 1 to 36, in a state of remission of depressive symptoms T or a pharma- ceutically acceptable salt thereof.

Images