Compositions comprising 5-methoxy-n,n-dimethyltryptamine (5-meo-DMT) for use in treating mental disorders

Abstract

To provide compositions for use in treating major depressive disorder.SOLUTION: Provided is 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, where the 5-MeO-DMT is administered via the intravenous, intramuscular or subcutaneous route.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] In the context of the present invention, 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered intravenously, It is administered by intramuscular or subcutaneous injection.

[0007] 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 drug may be administered at a dose or dosage regimen that provides a therapeutic effect. A molar amount of 5-MeO-DMT or an equimolar amount of a pharma- ceutically acceptable salt may be administered. .

[0008] 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.

[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 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.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] 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.

[0016] Further aspects of the present invention are defined below in the embodiments section. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] 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.

[0018] Further groups of hallucinogens include lysergic acid diethylamide (LSD), psilocybin and 5-Hydroxytryptamines (5-Hydroxytryptamines) such as N,N-dimethyltryptamine (DMT) T) receptors or serotonin receptors (seven families of 5-HT1 to 5-HT7 and 14 The latter group of compounds binds to serotonin receptors (serotonin receptor subtypes are described). Hallucinogens are often referred to as "classic hallucinogens" or "psychedelics", which Euphoria, trances, transcendence of time and space, spiritual experiences, collapse of self-boundaries or even near-death experiences This emphasizes their primary ability to induce qualitative alterations in states of consciousness such as sedation, Other effects such as coma or hyperstimulation are only minimal.

[0019] 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

[0020] [ka]

[0021] It is derived from tryptamine, which has the formula:

[0022] 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

[0023] 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. .

[0024] 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).

[0025] 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.

[0026] 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.

[0027] 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).

[0028] 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. 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 therapeutic methods as well as dosage regimens and routes of administration for such therapies. It is a further object of the present invention to provide a method for treating rheumatoid arthritis with a better safety profile than previously described treatments. Compounds for improved psychoactive therapy that have therapeutic potential and / or are well tolerated. and to provide dosage regimens and routes of administration for such therapy. Another object of the present invention is to provide compounds for more convenient and improved psychoactive therapies, as well as such Another object of the present invention is to provide a dosing regimen and route of administration for the therapy. With higher patient compliance rates than previously described therapies (including higher treatment initiation rates) Compounds for improved psychoactive therapy and dosage regimens for such therapy It is a further object of the present invention to provide such improved methods and routes of administration. Specific disease entities and specific subgroups of disease entities that would benefit from tailored psychoactive treatments The aim is to identify the

[0029] 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.

[0030] 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 tested so far based on drug regimen and route of administration were These effects persist for several hours after administration, which poses significant practical and convenience issues. The onset of a clinical response by The drug is sufficiently rapid to treat patients with active suicidal ideation, including those with Finally, some indications are essentially the same as those for these serotonergic psychedelics. Although it has been shown that certain disease entities and specific subtypes of disease entities are responsive to treatment with The subgroup has not yet been identified.

[0031] 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.

[0032] 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 mediate the full 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.

[0033] 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

[0034] 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 significantly different from those of the placebo-controlled drugs (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.

[0035] 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.

[0036] 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.

[0037] The inventors believe that the occurrence of peak experiences may be an important or minor mechanism for the therapeutic efficacy of psychedelic drugs. The inventors therefore recognized that the markers of oxidative stress are at least a surrogate behavioral marker of the underlying mechanisms. The authors compare peak experiences with previously tested psychedelics and their dosage regimens and administration route, more rapidly, in a higher percentage of patients, and with better individual patient relapse rates. Recognizing that achieving this with a high degree of accuracy results in a more favorable treatment profile I realized.

[0038] The inventors have demonstrated that 5-MeO-DMT (see formula below) is a potent antipsychotic that induces peak experiences. The trend is greater than that of serotonergic psychedelics previously investigated for the treatment of neurological disorders. The authors further identified 5-MeO-DMT as a potent serotonergic psychedelic drug. Peak experiences tend to involve the breakdown of ego boundaries and the experience of blissful states and / or oneness more frequently. The inventors have also recognized that 5-MeO-DMT may be useful for the treatment of neurological disorders. It is able to induce high experiences more rapidly than previously studied serotonergic psychedelics, The inventors have recognized that the duration of the psychedelic experience is shorter. These characteristics of MT are associated with an improved therapeutic profile and may lead to improved outcomes following 5-MeO-DMT treatment. We believe that this can be explained by specific changes in RSN activity based on the

[0039] [ka]

[0040] 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 found that these patients were responsive to treatment with T.

[0041] 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.

[0042] 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.

[0043] 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 Novel dosing regimen and route of administration of 5-MeO-DMT for use in the treatment of rheumatoid arthritis - Patents.com and achieving a peak experience in a high percentage of patients and with good reproducibility within the same patient. The new drug regimen and route of administration allow for high patient satisfaction and results. In addition to allowing for improved therapeutic outcomes with these novel dosing regimens and The dosing regimen also reduces the risk of overmedication, thereby improving the safety profile. Such improved dosing regimens may be increased with subsequent administrations on the same or following days. It depends on the dose of 5-MeO-DMT being administered to the same patient. The route of administration depends on the intravenous, intramuscular or subcutaneous administration of 5-MeO-DMT.

[0044] 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.

[0045] 5-MeO-DMT has a short duration of acute psychedelic effects (e.g., oral (5–20 min after intravenous injection compared with several hours for syphilis and oral LSD) The fact that it has an improved therapeutic effect is surprising, but in fact the short duration of this action and the absence of associated tolerance (i.e., reduced psychedelic effects after re-administration or The absence of loss (absence of loss) appears to increase the incidence of peak experiences and thereby increase therapeutic benefit. New medication regimens with frequent re-administration (e.g., more than once a day or daily) designed to Repeated administration within such a short period of time also reduces the risk of overdosing. Allows for intra-individual dose optimization to reduce the risk of otherwise causing serotonin syndrome, Physical side effects such as negative psychological reactions, such as flashbacks of the experience at a later time, or changes in Poor or non-existent memory of sexual status (so-called "whiteout"), This may result in a less intense psychedelic experience. Furthermore, starting with a lower dose may improve the patient's People are generally more accustomed to the psychedelic experience, and more intense symptoms occur at higher doses. This can have a positive impact on the experience of these higher doses. The prospect of being able to start treatment at a lower dose is a valuable insight into patient outcomes regarding this therapeutic approach. This will facilitate approval of new drugs and improve overall compliance rates at the patient population level.

[0046] 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 of psychedelic effects observed with their current dosing regimens and routes of administration and long duration and tolerability that may last for several days (i.e., no psychiatric benefit after rechallenge). for other psychedelics due to the rapid onset of psychedelic effects (decline or loss of psychedelic effect). This may not be possible with currently tested dosing regimens. The dosing regimens described so far for psychedelic drugs have consisted of only a single dose or several The study contemplated either repeated administration after 12 days or oral administration only. Therefore, with these currently used dosing regimens and routes of administration, best experience is not reliable. These regimens do not provide the additional benefits discussed above.

[0047] Intravenous, intramuscular or subcutaneous administration of 5-MeO-DMT results in high bioavailability. and low variability in bioavailability between patients and between re-administrations in the same patient. This allows for a high rate and reproducible supreme experience. Intramuscular or subcutaneous administration is preferred over inhalation or intranasal administration by at least some patients. It is considered simpler and better tolerated than Subcutaneous administration is preferred by at least some physicians due to ease of use. Intravenous, intramuscular or subcutaneous administration may be performed as directed by a physician or Avoid exposure of healthcare providers to 5-MeO-DMT.

[0048] 5-MeO-DMT acts as a 5-HT1A and 5-HT2A receptor agonist 5-M is a naturally occurring serotonergic psychedelic drug that acts as a tryptamine. eO-DMT was first identified in 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. It binds to the 5-HT2A receptor with much higher affinity than 5-MeO-DMT itself. do.

[0049] 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."

[0050] 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

[0051] 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 higher mean clinical response; c) faster onset of clinical response; d) more sustained clinical response; e) less Similar or better clinical response with no or different side effects, and therefore improvement improved compliance, and f) simpler treatment regimens involving fewer drug doses. The results showed that the same or better clinical response was achieved with In comparison with previously investigated psychedelic drugs, the present invention has the following advantages: g) a rapid increase in the Equivalent or better clinical response with shorter duration of psychoactive effects, resulting in improved h) improved ease of use and compliance; h) increased propensity to achieve peak psychedelic experiences; Greater and more reproducible achievement of the highest psychedelic experience while at the same time being unnecessary avoids the need for excessively high doses and associated side effects, is better tolerated and therefore It further provides improved dosing regimens and routes of administration with improved compliance. Moreover, the beneficial effects may be particularly pronounced in treatment-resistant patients as defined herein. It is noted that this is achieved.

[0052] 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 are typically used as well. An example of such a salt is the hydrochloride salt. The appropriate weight of the salt to be administered is calculated from the weight of the free base, assuming an equimolar amount is used. This may be done.

[0053] 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.

[0054] 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.

[0055] 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

[0056] 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

[0057] "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), 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 for bulimia nervosa and the frequency of binge eating episodes for binge eating disorder were frequency of attacks, duration of abstinence or reduction in substance use in psychoactive substance abuse, and Suicidality assessments such as the Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation Suicidal thoughts item of the standard scale or MADRS, or Clinical Global Impression-Suicidality Severity-Revised The revised (CGI-SS-R) scale (CGI-SS-R is derived from the CGI-S, with 0 = normal, 0 = completely normal) 1 = no suicidal tendencies, 1 = suspected suicidal tendencies, 2 = mild suicidal tendencies, 3 = moderate suicidal tendencies , 4=marked suicidality, 5=severe suicidality, and 6=extreme suicidality). Longer recall periods (e.g., typically 7 days for MADRS) Based on the endpoints developed for the early time point (e.g., 2 hours) after drug administration, ), reasonable modifications of such endpoints (e.g., MA The recall period of the DRS was changed to 2 hours, and the sleep items recorded at baseline before drug administration were included in the carryover) may be applied.

[0058] 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. This means that the active compound is introduced into the patient by intravenous administration or intramuscular administration. The drug is administered intravenously or subcutaneously.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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 suicidal ideation. This includes patients with major depressive disorder.

[0063] 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 10 mg. Specific amounts that are useful are, for example, about 1 mg, about 2 mg, or any range therein. , about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg, and about 1 0 mg. A pharma- ceutically acceptable salt of 5-MeO-DMT is preferably used in this embodiment. The appropriate weight of salt to be used and administered is the stated weight of the free base, assuming equimolar amounts are used. It is understood that the weight of the sample may be calculated from the weight of the sample.

[0064] In this specification, when a range such as "about 1 mg to about 10 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.

[0065] 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 the occurrence of a clinical response within about 2 hours after administration of 5-MeO-DMT.

[0066] In a preferred embodiment, these disorders are associated with suicidal ideation, such as treatment-resistant versions of these disorders. Mental disorders, especially major depressive disorder, persistent depressive disorder, anxiety disorder, post-traumatic stress disorder, etc. The present disclosure relates to individuals with autism, obsessive-compulsive disorder, eating disorder, and psychoactive substance abuse.

[0013] Improved methods for treating patients as defined herein with a therapeutically effective amount of 5-MeO-DMT reported that 5-MeO-DMT is a potent anti-inflammatory drug, with clinical responses occurring within approximately 2 hours after administration of 5-MeO-DMT. At least about 6 days after the last dose of DMT, preferably the last dose of 5-MeO-DMT and preferably at least about 14 days after the last administration of 5-MeO-DMT. This includes sustained clinical response for at least about 28 days.

[0067] In a preferred embodiment, the present invention relates to a method for treating these disorders, including treatment-resistant forms of these disorders and those associated with suicidal ideation. Mental disorders, including those related to depression, in particular major depressive disorder, persistent depressive disorder, anxiety disorders, post-traumatic stress disorder, 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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 10 mg to 150 mg.

[0072] 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 1 mg to about 2 mg, and then reaches 10 mg. or all doses in that treatment block are administered, whichever occurs first. with each subsequent administration within each treatment block, until

[0073] In an even more preferred embodiment, the dosage of 5-MeO-DMT administered to an individual patient The amount is selected from about 1 mg to about 2 mg for the first administration within each treatment block, followed by 10 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.

[0074] 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. Approximately 0.25 mg to approximately 3 mg, preferably approximately 0.5 mg to approximately 3 mg, and most preferably approximately 6 For example, the dosage of the first administration is 1 mg, and the dosage of If the dose increase is 3 mg, the second dose will be discontinued unless one of the discontinuation criteria above is met. The dosage of the administration is 4 mg. Preferably, the dosage of the third administration is 7 mg.

[0075] In a preferred embodiment, 5-MeO- is administered to individual patients in each treatment block. The dosage of the DMT is selected from about 1 mg to about 3 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 4 mg to about 6 mg, and the third administration is at a dose selected from about 7 mg to about 8 mg. The dosage is increased to a dose selected from about 10 mg to about 9 mg. Particular amounts are, for example, about 2 mg, about 5 mg, and about 8 mg.

[0076] In an even more preferred embodiment, the dosage of 5-MeO-DMT administered to an individual patient The amount is selected from about 1 mg to about 2 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 should be increased until the earlier of either the first or second dose escalation, or until a further dose escalation is determined to be inappropriate. The dose is increased with each subsequent dose within a treatment block, up to the maximum dose in that first treatment block. Dosages were calculated for all subsequent treatment blocks and for 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 it was 8mg because you experienced a peak psychedelic experience at that dose, all subsequent The dose for administration within the first and subsequent treatment blocks was 8 mg. do.

[0077] 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 1 mg to about 3 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, and for the second administration of the first treatment block, a dose selected from about 4 mg to about 6 mg. and for the third administration of the first treatment block, the dose is increased to a dose selected from about 7 mg to about 9 mg. The maximum dose in the first treatment block is added to all subsequent treatment blocks and and are used as the dose for administration in those subsequent treatment blocks. Useful specific amounts for the first, second and third administrations in a block are, for example, about 2 mg, about 5mg and about 8mg.

[0078] A pharma- ceutically acceptable salt of 5-MeO-DMT is used in all of the above dosing regimens. The appropriate weight of the salt preferably used and administered is, assuming equimolar amounts are used, It is understood that this may be calculated from the stated weight of the free base.

[0079] According to the present invention, 5-MeO-DMT is preferably not administered with an MAO inhibitor. stomach.

[0080] 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).

[0081] 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).

[0082] 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.

[0083] Therapeutically effective amounts of 5-MeO-DMT can be administered intravenously, intramuscularly, or Administration via these routes ensures rapid onset of action. The most preferred route of administration is via the intramuscular route, i.e., by intramuscular injection. It is given.

[0084] The 5-MeO-DMT is preferably in the form of a pharma- ceutically acceptable formulation for administration by injection. Examples of excipients and vehicles for such formulations include , are known in the art.

[0085] Patients may also undergo psychotherapeutic intervention.

[0086] 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 1 mg to about 10 mg. mg range and for dosing based on a pharma- ceutical acceptable salt of 5-MeO-DMT. and is administered intramuscularly in the form of a pharmaceutical formulation of 5-MeO-DMT. The weights of the salts are those of the free base of 5-MeO-DMT, assuming equimolar amounts are used. The useful weight of 5-MeO-DMT in this particular embodiment may be calculated from the weight of the Specific amounts include, for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg and about 10 mg.

[0087] 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 1 mg to about 10 mg. mg range and for dosing based on a pharma- ceutical acceptable salt of 5-MeO-DMT. and is administered intramuscularly in the form of a pharmaceutical formulation of 5-MeO-DMT. The weights of the salts are those of the free base of 5-MeO-DMT, assuming equimolar amounts are used. The useful weight of 5-MeO-DMT in this particular embodiment may be calculated from the weight of the Specific amounts include, for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about In this same particular embodiment, the - MADRS or HAM-D compared with the respective scores before administration of 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. -Occurs within approximately 2 hours after administration of MeO-DMT.

[0088] 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 1 mg to about 10 mg. mg range and for dosing based on a pharma- ceutical acceptable salt of 5-MeO-DMT. and is administered intramuscularly in the form of a pharmaceutical formulation of 5-MeO-DMT. The weights of the salts are those of the free base of 5-MeO-DMT, assuming equimolar amounts are used. The useful weight of 5-MeO-DMT in this particular embodiment may be calculated from the weight of the Specific amounts include, for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about In this same particular embodiment, the Depression as determined by a MADRS score of 0 or less or a HAM-D score of 7 or less Remission of the symptoms occurs within approximately 2 hours after administration of 5-MeO-DMT.

[0089] 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 1 mg to about 10 mg. mg range and for dosing based on a pharma- ceutical acceptable salt of 5-MeO-DMT. and is administered intramuscularly in the form of a pharmaceutical formulation of 5-MeO-DMT. The weights of the salts are those of the free base of 5-MeO-DMT, assuming equimolar amounts are used. The useful weight of 5-MeO-DMT in this particular embodiment may be calculated from the weight of the Specific amounts include, for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about In this same particular embodiment, the - 5-MeO-DMT, including clinical responses occurring within approximately 2 hours after administration of MeO-DMT At least one improvement in MADRS or HAM-D scores compared with the respective scores before administration of Clinical response as determined by 50% improvement or CGI-I or PGI-I score Clinical response, measured as a score of at least "marked improvement," was achieved with 5-MeO-DMT. At least about 6 days after the last dose, preferably at least 1 day after the last dose of 5-MeO-DMT. At least about 14 days after the last administration of 5-MeO-DMT, and more preferably at least It lasts for about 28 days.

[0090] 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 1 mg to about 3 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 dose is at a dose selected from about 4 to about 6 mg, and the first dose of the first treatment block is at a dose selected from about 4 to about 6 mg. The third dose is increased to a dose selected from about 7 mg to about 9 mg, and the first treatment block is The maximum dose in a treatment block is the same as that in all subsequent treatment blocks and their successors. The dose for administration within the first and second treatment blocks is used. and useful specific amounts for the third administration are, for example, about 2 mg, about 5 mg, and about 8 mg. In this same particular embodiment, the interval between each administration within the first treatment block is about 3 hours. In this same particular embodiment, 5-MeO-DMT is a 5-MeO-DMT pharmacologic It is administered intramuscularly in the form of a formulation for administration based on an acceptable salt, and is 5-Me The weight of the pharma- ceutically acceptable salt of O-DMT is calculated assuming equimolar amounts are used: 5-Me This may be calculated from the stated weight of the free base of O-DMT. 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). Achieving at least 60% of the maximum possible score on each (Barrett FS, J Psychopharma col. 2015;29(11):1182-90), or at least 75 other psychedelic drugs. This is identified by achieving a total score on the Personal Care Experience Questionnaire (PPEQ).

[0091] 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 1 mg to about 3 mg for the first administration, and then the patient receives the treatment block. Unless the participant has already had a peak psychedelic experience within the facility or is under observation 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 from about 4 mg to about 6 mg, and the second dose is from about 7 mg to about 9 mg. g. The first, second and third doses in the first treatment block are increased to a dose selected from Useful specific amounts for administration of 3 are, for example, about 2 mg, about 5 mg, and about 8 mg. In this particular embodiment, the interval between each administration within each treatment block is about 3 hours, The interval between the end of the placement block and the start of the next treatment block is approximately 6 days. In embodiments, the 5-MeO-DMT is based on a pharma- ceutically acceptable salt of 5-MeO-DMT. The drug is administered intramuscularly in the form of a formulation for quick administration, and the pharmaceutical properties of 5-MeO-DMT are The weight of salt permitted for is the free salt of 5-MeO-DMT, assuming equimolar amounts are used. In this same particular embodiment, the amount of the supreme psychedelic The occurrence of mystical experiences was assessed using four subscales of the 30-item Revised Mystical Experiences Questionnaire (MEQ30). (Mysticism, positive mood, time-space transcendence and ineffability) Achieving at least 60% of the maximum score (Barrett FS, J Psychopharmacol. 2015;29(11):1 182-90), or at least 75 Peak Psychedelic Experiences Questionnaire (P It is identified by achieving a total score on the PEQ.

[0092] 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 1 mg for the first administration of the first treatment block. ~3mg, 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 4 mg of to about 6 mg in the third dose of the first treatment block, and 5. The dose of the first treatment block is increased to a dose selected from about 10 mg to about 9 mg. Dosages were calculated for all subsequent treatment blocks and for administration within those subsequent treatment blocks. The first, second and third doses in the first treatment block were used as the doses of Useful specific amounts are, for example, about 2 mg, about 5 mg, and about 8 mg. In an embodiment, the interval between each administration within the first treatment block is about 3 hours. In embodiments, the 5-MeO-DMT is based on a pharma- ceutically acceptable salt of 5-MeO-DMT. The drug is administered intramuscularly in the form of a formulation for quick administration, and the pharmaceutical properties of 5-MeO-DMT are The weight of salt permitted for is the free salt of 5-MeO-DMT, assuming equimolar amounts are used. In this same particular embodiment, the amount of the supreme psychedelic The occurrence of mystical experiences was assessed using four subscales of the 30-item Revised Mystical Experiences Questionnaire (MEQ30). (Mysticism, positive mood, time-space transcendence and ineffability) Achieving at least 60% of the maximum score (Barrett FS, J Psychopharmacol. 2015;29(11):1 182-90), or at least 75 Peak Psychedelic Experiences Questionnaire (P It is identified by achieving a total score on the PEQ.

[0093] 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 1 mg to about 3 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 4 mg to about 6 mg, and the third administration is at a dose selected from about 7 mg to about 8 mg. The first and second treatment blocks are increased to a dose selected from about 10 mg to about 9 mg. Useful specific amounts for the second and third administrations are, for example, about 2 mg, about 5 mg, and about 8 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 certain embodiments of the same, 5-MeO-DMT is a pharma- ceutically acceptable form of 5-MeO-DMT. 5-MeO-DM is administered intramuscularly in the form of a salt-based formulation for administration. The weight of the pharma- ceutically acceptable salt of T is 5-MeO-DMSO, assuming equimolar amounts are used. In this same particular embodiment, the amount of T that is The occurrence of high psychedelic experiences was assessed using four items of the 30-item Revised Mystical Experiences Questionnaire (MEQ30). In each of the subscales (mystical, positive mood, transcendence of time and space, and ineffability), Achieving at least 60% of the maximum possible score on the 5;29(11):1182-90), or at least 75 peak psychedelic experiences This is identified by the achievement of a total score on the questionnaire (PPEQ).

[0094] Embodiment Specific embodiments of the present invention are listed below.

[0095] 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.

[0096] 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.

[0097] 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 7 mg to about 9 mg, or 5-MeO- The method according to any one of embodiments 1 to 12, 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 as described above. 14. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 14. The use according to claim 13, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular administration. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 23. 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 The use of any one of embodiments 1 to 22, 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 24. Determined by a MADRS score of ≤10 or a HAM-D score of ≤7 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 23, which occurs within about 2 hours after or a pharma- ceutically acceptable salt thereof. 25. 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 The method according to any one of embodiments 1 to 24, 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. 26. 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 25, the present invention is effective 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. 27. 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 26 in remission of depressive symptoms T or a pharma- ceutically acceptable salt thereof. 28. 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 According to any one of embodiments 1 to 27, 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. 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 75% improvement in 5-MeO-DMT or pharmacological The use according to any one of embodiments 1 to 28, which is present 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 30. The patient has not received any of the following treatments within 14 days of the last dose 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-D for use according to embodiments 1 to 29, in a state of remission of depressive symptoms MT or a pharma- ceutically acceptable salt thereof. 31. 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 According to any one of embodiments 1 to 30, 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. 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 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. 33. The patient has been in the 5-MeO-DMT or pharmacologic 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 32 in patients in a state of remission of depressive symptoms MT or a pharma- ceutically acceptable salt thereof. 34. For the use according to embodiments 1 to 33, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 35. 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 34. salt. 36. The first treatment block is 5-MeO-DMT as defined in embodiments 9-18 or 5-MeO-DMT or its salts for use according to embodiments 34-35. means a pharma- ceutically acceptable salt thereof. 37. 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 34 to 36, 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. 38. 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 34 to 37, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 39. 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 34 or 38, including administration and a commercially acceptable salt thereof. 40.5-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 according to any one of embodiments 1 to 33, 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 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 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 33.

[0098] 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, 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 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 7 mg to about 9 mg, or 5-MeO- The method according to any one of embodiments 1 to 12, 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 as described above. 14. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 14. The use according to claim 13, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 23. 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 The use of any one of embodiments 1 to 22, 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 24. Determined by a MADRS score of ≤10 or a HAM-D score of ≤7 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 23, which occurs within about 2 hours after or a pharma- ceutically acceptable salt thereof. 25. 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 The method according to any one of embodiments 1 to 24, 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. 26. 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 25, the present invention is effective 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. 27. 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 26 in remission of depressive symptoms T or a pharma- ceutically acceptable salt thereof. 28. 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 As described in embodiment 27, which 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 in 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 75% improvement in 5-MeO-DMT or pharmacological The use according to any one of embodiments 1 to 28, which is present 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 30. The patient has not received any of the following treatments within 14 days of the last dose 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-D for use according to embodiments 1 to 29, in a state of remission of depressive symptoms MT or a pharma- ceutically acceptable salt thereof. 31. 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 According to any one of embodiments 1 to 30, 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. 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 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. 33. The patient has been in the 5-MeO-DMT or pharmacologic 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 32 in patients in a state of remission of depressive symptoms MT or a pharma- ceutically acceptable salt thereof. 34. For the use according to embodiments 1 to 33, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 35. 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 34. salt. 36. The first treatment block is 5-MeO-DMT as defined in embodiments 9-18 or 5-MeO-DMT or its salts for use according to embodiments 34-35. means a pharma- ceutically acceptable salt thereof. 37. 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 34 to 36, 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. 38. 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 34 to 37, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 39. 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 34 or 38, including administration and a commercially acceptable salt thereof. 40.5-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 according to any one of embodiments 1 to 33, 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 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. 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 33. .

[0099] 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 5-MeO-DMT) or a pharma- ceutical acceptable salt thereof, 5-MeO-DMT or a pharma- ceutical acceptable Rusono salt. 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 7 mg to about 9 mg, or 5-MeO- The method according to any one of embodiments 1 to 12, 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 as described above. 14. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 14. The use according to claim 13, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 23. At least an 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 use according to any one of embodiments 1 to 22, 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 24.9 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 23, which occurs within about 2 hours after administration of T or a pharma- ceutically acceptable salt thereof. 25. At least an 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 25. The method according to claim 1, wherein the administration of the salt of said compound lasts for at least 6 days after the last administration of said compound. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use. 26. 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 26. The method according to claim 1, wherein the medicament is administered on the 7th day after the last administration of the salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 27. 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. 28. 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 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 75% improvement in 5-MeO-DMT or pharmacologic For the use according to any one of embodiments 1 to 28, the method is performed 14 days after the last administration of the salt thereof. or a pharma- ceutically acceptable salt thereof. 30. The patient has not received any of the following treatments within 14 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof: 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 5-MeO-DMT for use according to embodiments 1 to 29 in a state of symptomatic remission means a pharma- ceutically acceptable salt thereof. 31. 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 claims 1 to 30, wherein the administration of the salt lasts for at least 28 days after the last administration of the salt. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use in 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 75% improvement in 5-MeO-DMT or pharmacologic For the use according to any one of embodiments 1 to 31, the method is performed 28 days after the last administration of the salt thereof. or a pharma- ceutically acceptable salt thereof. 33. The patient has been in the 5-MeO-DMT or pharmacologic 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 5-MeO-DMT for use according to embodiments 1 to 32 in a state of symptomatic remission means a pharma- ceutically acceptable salt thereof. 34. For the use according to embodiments 1 to 33, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 35. 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 34. salt. 36. The first treatment block is 5-MeO-DMT as defined in embodiments 9-18 or 5-MeO-DMT or its salts for use according to embodiments 34-35. means a pharma- ceutically acceptable salt thereof. 37. 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 34 to 36, 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. 38. 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 34 to 37, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 39. 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 34 or 38, including administration and a commercially acceptable salt thereof. 40.5-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 according to any one of embodiments 1 to 33, 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 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. 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 33. .

[0100] 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, 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. 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 7 mg to about 9 mg, or 5-MeO- The method according to any one of embodiments 1 to 12, 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 as described above. 14. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 14. The use according to claim 13, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 23. 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 The use according to any one of embodiments 1 to 22, 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 24. 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 23 occurring within about 7 days after the last administration of the salt. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. 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 24, 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. 26. 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 For the use according to embodiments 1 to 25, the present invention is effective 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. 27. 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 26, the patient is in a state of remission of symptoms of post-traumatic stress disorder. or a pharma- ceutically acceptable salt thereof. 28. 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 27, 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. 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 50% improvement in schizophrenia, was observed with either 5-MeO-DMT or pharmacological The use according to any one of embodiments 1 to 28, which is present 14 days after the last administration of an acceptable salt thereof. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 30. The patient has not received any of the following treatments within 14 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof: 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 29, 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. 31. 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 30, 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. 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 50% improvement in 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. 33. The patient has been in the 5-MeO-DMT or pharmacologic 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 32, 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. 34. For the use according to embodiments 1 to 33, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 35. 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 34. salt. 36. The first treatment block is 5-MeO-DMT as defined in embodiments 9-18 or 5-MeO-DMT or its salts for use according to embodiments 34-35. means a pharma- ceutically acceptable salt thereof. 37. 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 34 to 36, 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. 38. 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 34 to 37, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 39. 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 34 or 38, including administration and a commercially acceptable salt thereof. 40.5-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 according to any one of embodiments 1 to 33, 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 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 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 33.

[0101] 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- ceutical acceptable salt thereof, 5-MeO-DMT or a pharma- ceutical acceptable salt thereof, administered by intravenous, intramuscular or subcutaneous routes. The salt that will be used. 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 7 mg to about 9 mg, or 5-MeO- The method according to any one of embodiments 1 to 12, 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 as described above. 14. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 14. The use according to claim 13, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 23. 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 22, occurring within about 7 days after administration T or a pharma- ceutically acceptable salt thereof. 24. 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 for use according to embodiments 1 to 23, Acceptable salts thereof. 25. 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 24, which persists for at least 14 days after administration. eO-DMT or a pharma- ceutically acceptable salt thereof. 26. At least 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 25, present on the 7th day after administration or a pharma- ceutically acceptable salt thereof. 27. 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 26 in remission and a commercially acceptable salt thereof. 28. 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 27, which persists for at least 21 days after administration. eO-DMT or a pharma- ceutically acceptable salt thereof. 29. At least a 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 28, present on the 14th day after administration or a pharma- ceutically acceptable salt thereof. 30. The patient has not received any of the following treatments within 14 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof: 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 29, in a state of remission of A physiologically acceptable salt thereof. 31. 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 30, which persists for at least 28 days after administration. eO-DMT or a pharma- ceutically acceptable salt thereof. 32. 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 31, present on the 28th day after administration or a pharma- ceutically acceptable salt thereof. 33. The patient has been in the 5-MeO-DMT or pharmacologic 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 32, in a state of remission of A physiologically acceptable salt thereof. 34. For the use according to embodiments 1 to 33, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 35. 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 34. salt. 36. The first treatment block is 5-MeO-DMT as defined in embodiments 9-18 or 5-MeO-DMT or its salts for use according to embodiments 34-35. means a pharma- ceutically acceptable salt thereof. 37. 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 34 to 36, 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. 38. 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 34 to 37, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 39. 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 34 or 38, including administration and a commercially acceptable salt thereof. 40.5-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 according to any one of embodiments 1 to 33, 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 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. 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 33. .

[0102] 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- ceutical acceptable salt thereof, 5-MeO-DMT or a pharma- ceutical acceptable salt thereof, administered by intramuscular or subcutaneous routes. The salt that can be used. 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 7 mg to about 9 mg, or 5-MeO- The method according to any one of embodiments 1 to 12, 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 as described above. 14. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 14. The use according to claim 13, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 23. 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 22 occurring within 7 days A pharma- ceutically acceptable salt thereof. 24. 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. 25. 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 24, which lasts for at least 14 days. MT or a pharma- ceutically acceptable salt thereof. 26. 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 25, and a commercially acceptable salt thereof. 27. 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 26. The salt that can be used. 28. 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 27, which lasts for at least 21 days. MT or a pharma- ceutically acceptable salt thereof. 29. At least 50% improvement in the YBOCS compared to pretreatment scores. The clinical response observed is within 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 28 present on day 4 A physiologically acceptable salt thereof. 30. The patient has not received any of the following treatments within 14 days of the last dose of 5-MeO-DMT or a pharma- ceutical acceptable salt thereof: 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 29. The salt that will be used. 31. 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 30, which lasts for at least 28 days. MT or a pharma- ceutically acceptable salt thereof. 32. 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 31 present on day 8 A physiologically acceptable salt thereof. 33. The patient has been in the 5-MeO-DMT or pharmacologic 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 32. The salt that will be used. 34. For the use according to embodiments 1 to 33, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 35. 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 34. salt. 36. The first treatment block is 5-MeO-DMT as defined in embodiments 9-18 or 5-MeO-DMT or its salts for use according to embodiments 34-35. means a pharma- ceutically acceptable salt thereof. 37. 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 34 to 36, 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. 38. 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 34 to 37, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 39. 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 34 or 38, including administration and a commercially acceptable salt thereof. 40.5-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 according to any one of embodiments 1 to 33, 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 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. 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 33. .

[0103] 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, 5-MeO-DMT or pharmaceuticals administered by intravenous, intramuscular or subcutaneous routes Acceptable salts 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 2 Severe 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 Use higher dosages than previously administered unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 10. . 13.5-MeO-DMT is administered in a first dose of about 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 17 mg to about 9 mg, or 5-MeO - In embodiments 1 to 12, 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 the uses described. 14. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 14. The use according to claim 13, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. A decrease in body mass index of at least 1% compared to pre-treatment with 23.5-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 22, 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 24. 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 23, and a commercially acceptable salt thereof. At least 1% decrease in body mass index compared to pre-treatment with 25.5-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 24, 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 26.5-MeO-DMT kg / m 2 A clinical response, as determined by an increase in the For the use according to embodiments 1 to 25, 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. 27. The patient has been in the 56-month follow-up 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. 28. For the use according to embodiments 1 to 27, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 29. 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 28. salt. 30. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 18 or 5-MeO-DMT or a salt thereof for use according to embodiments 28-29, including administration of means a pharma- ceutically acceptable salt thereof. 31. 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 28 to 30, 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. 32. 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 28 to 31, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 33. 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 28 or 32, including administration and a commercially acceptable salt thereof. 34.5-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 27, 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 35.5-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 27. .

[0104] 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- ceutical acceptable salt thereof, 5-MeO-DMT or a pharma- ceutical acceptable salt thereof, administered by intravenous, intramuscular or subcutaneous routes. The salt that will be used. 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 17 mg to about 9 mg, or 5-MeO - In embodiments 1 to 12, 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 the uses described. 14. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 14. The use according to claim 13, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 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 23.5-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 for use according to embodiments 1 to 22, Acceptable salts thereof. 24. 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 composition for use according to embodiments 1 to 23, and its salts which are acceptable to. Compared to the number of binge eating and vomiting episodes per week before administration of 25.5-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 24, 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 26.5-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 25. The salt that will be used. 27. 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 26, 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 28.5-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 27, 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 29.5-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 28. The salt is acceptable. 30. The patient has been in the 5-MeO-DMT or pharmacologic 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 29, 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 31.5-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 30, 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 32.5-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 31. The salt is acceptable. 33. The patient has been in the 5-MeO-DMT or pharmacologic 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 32, in a state of remission of A physiologically acceptable salt thereof. 34. For the use according to embodiments 1 to 33, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 35. 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 34. salt. 36. The first treatment block is 5-MeO-DMT as defined in embodiments 9-18 or 5-MeO-DMT or its salts for use according to embodiments 34-35. means a pharma- ceutically acceptable salt thereof. 37. 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 34 to 36, 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. 38. 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 34 to 37, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 39. 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 34 or 38, including administration and a commercially acceptable salt thereof. 40.5-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 according to any one of embodiments 1 to 33, 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 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. 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 33. .

[0105] 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- ceutical acceptable salt thereof, 5-MeO-DMT or a pharma- ceutical acceptable salt thereof, administered by intramuscular or subcutaneous routes. The salt that can be used. 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. 9.5-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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 Use higher dosages than previously administered unless the individual experiences a peak psychedelic experience. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use according to forms 1 to 10. . 13.5-MeO-DMT is administered in a first dose of about 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 17 mg to about 9 mg, or 5-MeO - In embodiments 1 to 12, 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 the uses described. 14. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 14. The use according to claim 13, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. The number of binge eating episodes per week after 23.5-MeO-DMT compared to the number of binge eating episodes per week before 23.5-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 22. Rusono salt. 24. 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 23. The salt that will be used. The number of binge eating episodes per week after 25.5-MeO-DMT compared to the number of binge eating episodes per week before 25.5-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 24, and its salts which are acceptable to. 26. The number of binge eating episodes per week after 5-MeO-DMT compared to the number of binge eating episodes per week before 5-MeO-DMT 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 25. Salt. 27. 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 26 in the Acceptable salts thereof. Compared to the number of binge eating episodes per week before administration of 28.5-MeO-DMT, A clinical response as determined by at least a 50% reduction in the number of binge eating episodes per day. At least 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 27, and its salts which are acceptable to. 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 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. 30. The patient has been in the 5-MeO-DMT or pharmacologic 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 29 in the Acceptable salts thereof. 31.5-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 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 30, and its salts which are acceptable to. 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 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. 33. The patient has been in the 5-MeO-DMT or pharmacologic 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 32 in the Acceptable salts thereof. 34. For the use according to embodiments 1 to 33, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 35. 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 34. salt. 36. The first treatment block is 5-MeO-DMT as defined in embodiments 9-18 or 5-MeO-DMT or its salts for use according to embodiments 34-35. means a pharma- ceutically acceptable salt thereof. 37. 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 34 to 36, 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. 38. 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 34 to 37, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 39. 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 34 or 38, including administration and a commercially acceptable salt thereof. 40.5-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 according to any one of embodiments 1 to 33, 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 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. 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 33. .

[0106] 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, 5-MeO-DMT or pharmaceuticals administered by intravenous, intramuscular or subcutaneous routes Acceptable salts 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, 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. 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 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 17 mg to about 9 mg, or 5-MeO - In embodiments 1 to 12, 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 the uses described. 14. The first dose of 5-MeO-DMT was approximately 2 and the second dose of 5-MeO-DMT was approximately 2. and the third dose of 5-MeO-DMT is about 8 mg; or Embodiment 13, in which 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 as described in claim 1. 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 for use according to any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharma- ceutically acceptable salt thereof. 19. 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 18, and a commercially acceptable salt thereof. 20. 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 19, wherein the administration of 5-MeO-DMT or a pharma- ceutically 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 lasts for at least 14 days after the last administration of 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 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 11 DSM-13 for substance use disorder compared to the number prior to administration of 23.5-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 22, and a commercially acceptable salt thereof. 24. There are 0 of the 11 DSM-5 diagnostic criteria for substance use disorders Remission from psychoactive substance abuse, as measured by 5-MeO-DMT or pharmacological The use of any one of embodiments 1 to 23, 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 25.5-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 24, 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 the number prior to administration of 26.5-MeO-DMT - 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 25, Acceptable salts thereof. 27. 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 26, 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 28.5-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 27, both of which last for up to 21 days. or a pharma- ceutically acceptable salt thereof. 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 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 28, which is present in the eye and its salts which are acceptable to. 30. The patient has been in the 5-MeO-DMT or pharmacologic 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 29, 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-124 for substance use disorder compared to 31.5-MeO-DMT pre-treatment count - 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 30, both of which last for up to 28 days. or a pharma- ceutically acceptable salt thereof. 11 DSM-13 for substance use disorder compared to 32.5-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 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 31, which is present in the eye and its salts which are acceptable to. 33. The patient has been in the 5-MeO-DMT or pharmacologic 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 32, 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 34. For the use according to embodiments 1 to 33, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 35. 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 34. salt. 36. The first treatment block is 5-MeO-DMT as defined in embodiments 9-18 or 5-MeO-DMT or its salts for use according to embodiments 34-35. means a pharma- ceutically acceptable salt thereof. 37. 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 34 to 36, 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. 38. 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 34 to 37, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 39. 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 34 or 38, including administration and a commercially acceptable salt thereof. 40.5-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 according to any one of embodiments 1 to 33, 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 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. 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 33. .

[0107] 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 a salt thereof which is acceptable for administration by intravenous, intramuscular or subcutaneous route. 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 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 1 mg to about 10 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 2 mg or about 5 mg or about 8 mg is administered, or 5-Me 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. 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 1 mg to about 3 mg; The second dose is then approximately 4 mg unless the patient has already experienced a peak psychedelic experience. ~6mg, after which the patient is already experiencing a peak psychedelic experience. Unless otherwise specified, the third dose is increased to about 17 mg to about 9 mg, or 5-MeO - The method according to any one of embodiments 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 as described above. 11. The first dose of 5-MeO-DMT was approximately 2 mg, and the second dose of 5-MeO-DMT was approximately 2 mg. a third dose of 5-MeO-DMT is about 8 mg; and In the embodiment, an equimolar amount of a pharma- ceutically acceptable salt is administered instead of 5-MeO-DMT. 11. The use according to claim 10, wherein the 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered in a manner similar to that described above. 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 for use according to any of the preceding embodiments, administered by intramuscular injection -MeO-DMT or a pharma- ceutically acceptable salt thereof. 16. 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 15, and a commercially acceptable salt thereof. 17. 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 16, the method of claim 1, wherein ... 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 18. 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 17, the method lasts for at least 14 days after the last administration of or a pharma- ceutically acceptable salt thereof. 19. 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 embodiments 1 to 18, the method lasts for at least 28 days after the last administration of or a pharma- ceutically acceptable salt thereof. 20. 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 19, which occurs within about 2 hours after or a pharma- ceutically acceptable salt thereof. 21. 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. 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 20, occurring within about 2 hours after the last administration of the salt. MeO-DMT or a pharma- ceutically acceptable salt thereof. 22. 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 21, which persists for at least 6 days after DMT or a pharma- ceutically acceptable salt thereof. 23. 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. 24. 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 23, in remission of depressive symptoms and suicidal thoughts -MeO-DMT or a pharma- ceutically acceptable salt thereof. 25. 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 24, which persists for at least 14 days after - DMT or a pharma- ceutically acceptable salt thereof. 26. 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. 27. 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 26, 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 28. 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 27, which persists for at least 28 days after - DMT or a pharma- ceutically acceptable salt thereof. 29. 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. 30. The patient has not received any of the following treatments within 28 days of 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 29, 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. 31. For the use according to embodiments 1 to 30, administered in one or more treatment blocks or a pharma- ceutically acceptable salt thereof. 32. 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 31. salt. 33. The first treatment block is 5-MeO-DMT as defined in embodiments 9 to 18 or 5-MeO-DMT or its salts for use according to embodiments 31-32. means a pharma- ceutically acceptable salt thereof. 34. 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 31 to 33, 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. 35. 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 31 to 34, the administration period being from about 1 hour to about 24 hours. MT or a pharma- ceutically acceptable salt thereof. 36. 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 31 or 35, and a commercially acceptable salt thereof. 37.5-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 30, 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 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. 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 30. . EXAMPLES

[0108] 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.

[0109] [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:

[0110] [Table 1]

[0111] 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.

[0112] Step 2: 200 μl of solution is placed into a dosing capsule (Storz & Bickel, Germany) and the dosing capsules are closed with caps.

[0113] Step 3: The dosage capsule filled with the 5-MeO-DMT ethanol solution is heated to 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.

[0114] 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) is filled. Attach it to the socket of the chamber, seal the filling chamber and immediately afterwards increase the air flow to about 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.

[0115] 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 the state.

[0116] 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.

[0117] [Example 1B] 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 %.

[0118] The table below shows the impurity profile of the isolated material.

[0119] [Table 2]

[0120] 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 Reduced to below the target of NMT 0.10%.

[0121] Solvent analysis of the sample revealed an MTB of 17 ppm, compared to the expected limit of NMT 5000 ppm. E levels were indicated.

[0122] [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.

[0123] 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 discontinued because the patient did not show adequate improvement following at least two adequate courses of physical therapy. was considered resistant.

[0124] [Table 3]

[0125] result: The patient completed all scheduled visits. The inhalation procedure was performed appropriately by the patient. The drug was well tolerated with no inhalation-related adverse events. psychedelic symptoms have occurred. The duration of the psychedelic experience as judged by an outside observer The duration was 16 minutes in patient 1 and 40 minutes in patient 2.

[0126] Transient, clinically irrelevant increases in heart rate and blood pressure immediately following administration of 5-MeO-DMT Except for the rise in blood pressure, no other notable changes occurred in vital parameters. hour), safety laboratory analysis (hours 3 and 7), CADSS (hours 3 and 1 day The evaluation of cognitive tests (PVT, DSST, days 1 and 7) was performed. The few reported adverse events were mild and short-lived and resolved spontaneously by the end of the study. It disappeared spontaneously (Example 2, Table 2).

[0127] [Table 4]

[0128] Regarding the intensity of the psychedelic experience, patient 1 scored highest on all three judgment scores. Patient 1 met the criteria for Ikedelic experience, whereas patient 2 met the criteria for MEQ30 and PPEQ. However, the criteria for ASC were not met (Example 2, Table 3).

[0129] [Table 5]

[0130] Surprisingly, the patient showed a significant improvement in the MADRS, P They reported major improvements in their depressive symptoms as assessed by the GI-S and PGI-I. The effect became more pronounced over time (Example 2, Table 4). The patient also At the time of assessment, MADRS response (at least 50% improvement from baseline) and MAD Met the standard criteria for RS remission (MADRS total score of 10 or less) and The PGI-I rated their depressive symptoms as “very severe” and the PGI-I rated their depressive symptoms as “normal” and “not sick at all.” The results were very surprising, with most participants reporting either "significantly improved" or "much improved" be.

[0131] Patients were assessed using the suicidal thoughts item of the MADRS and the suicidal ideation item of the C-SSRS. They also showed improvement in their assessment of suicidality after drug administration. Other common psychiatric symptoms assessed by the This also improved after drug administration.

[0132] Importantly, Patient 1 and Patient 2 displayed similar psychedelic effect intensities, which This observation suggests that the occurrence of peak experiences is related to the effects of 5-MeO -A key mechanism for the therapeutic efficacy of DMT, or at least a surrogate for the underlying mechanism It is supported that it is a marker.

[0133] [Table 6]

[0134] Summary and conclusion: A. A single dose of 12 mg of 5-MeO-DMT administered by inhalation was well tolerated. This is a surprising and highly significant clinical finding in patients formally diagnosed with treatment-resistant major depressive disorder. Such striking clinical responses in treatment-resistant patients have demonstrated previously unmet medical needs. It is likely that treated patients will also experience a clinical response. B. Clinical responses occur rapidly within 2 hours after administration of 5-MeO-DMT. Tricyclic antidepressants are rarely rapid onset and generally take 4-6 weeks to show their effects. Drugs, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), serotonin The traditional class of anti-carcinoma drugs includes serotonin-norepinephrine reuptake inhibitors (SNRIs) This has not been observed with any drug. C. The patient experienced clinical remission within 2 hours after a single dose of 5-MeO-DMT. The study was conducted in a randomized controlled trial that compared the efficacy of other approved treatments for major depressive disorder with that of all previously tested treatments. It is highly superior to chedelic agents. D. Clinical response is seen when 5-MeO-DMT is administered once and is no longer absorbed by the body within this time frame. Despite the absence of any significant (See pharmacokinetic data in Example 3 below.) This observation supports the conclusion that 5-MeO-D The favorable clinical profile of MT supports it and allows for convenient dosing intervals. The traditional class of antidepressants was oral medication for daily administration over an extended period of time. E. In addition to the antidepressant effect, the endpoint of assessing suicidal ideation was positively affected and was followed up. Patients who are at immediate risk of suicide, such as those with active suicidal ideation accompanied by the intention to commit suicide This supports the use of 5-MeO-DMT in patients with suicidal ideation, such as: F. In addition to its antidepressant effect, it also reduces other psychiatric symptoms (such as hypochondria, anxiety, guilt, and tension). The endpoints assessed were also positively affected, with a 5-fold increase in patients with other psychiatric disorders. The use of MeO-DMT is supported. G. Intensity of acute psychedelic effects following 5-MeO-DMT administration and acute and long-term anti-angiogenic effects A correlation between the effectiveness of the treatment and the peak experience was observed, which allowed patients to experience peak experiences more rapidly and with greater The benefits of this approach include improved reproducibility in individual patients and improved treatment profile. Peak psychedelic experiences have been demonstrated in some patients at low doses of 5 -This can already occur with MeO-DMT (e.g., 6 mg, see Example 3 below), but other The observation that some patients require high doses (e.g., 18 mg, see Example 3 below). This supports the therapeutic efficacy of a wide range of 5-MeO-DMT doses and In patients who do not achieve a peak experience after the first dose of MT, any subsequent doses may be administered until the patient reaches the peak. Higher dosages should be used than previously administered until a high psychedelic experience is experienced. The concept is supported.

[0135] Each of the above aspects A)-G) is unexpected and highly medically relevant. 5-MeO-DMT, when used in accordance with the present invention, is effective in treating major depressive disorder. Compared to pharmacological treatments approved for the treatment of depression and all previously tested psychedelics The study shows that the drug has a significantly improved efficacy profile for acute psychedelic effects. These data, combined with the short duration and favorable safety profile, suggest that The present invention provides a method for treating a variety of conditions, including the development of a novel ... The identification of 5-MeO-DMT observed in this study Based on the effect of on psychiatric symptoms, the technical issues are persistent depressive disorder, anxiety disorder, , post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse. It is likely that this issue will also be resolved.

[0136] [Example 3] Clinical trials of 5-MeO-DMT administered by inhalation to healthy volunteers Research design: A clinical trial was conducted to evaluate the efficacy and safety of 5-MeO-DMT free base (purity ≥ 99%) at different dose levels. ) in healthy volunteers with a history of synthetic or naturally occurring psychedelic drug use. Volunteers were administered the drug by inhalation for one day (as described in Example 1). The study was reviewed and approved by the competent authorities and local pharmaceutical ethics committees in Japan. Part A consisted of 2 mg, 6 mg, 12 mg, and 18 mg of 5-M In Part B, a single dose of 6 mg of 5-MeO-DMT was administered. The first dose was administered, and then participants were asked to confirm that they had already experienced a peak psychedelic experience based on the PPEQ. Unless a patient is receiving a steroid or the supervising physician has determined that further dose increases are not necessary based on observed side effects, Unless determined appropriate, further subsequent dosages of 12 mg and 18 mg each will be administered. Participants in Part A received only one dose, with approximately 3 hours between doses. Higher doses were not permitted in later stages, and participation in Part B was not permitted. Participants were closely monitored for 3.5 hours after the last dose and 1 day after dosing and An additional follow-up visit was conducted 7 days later. Various safety-related endpoints (e.g., adverse events) were Elephant reports, safety laboratory analysis, vital signs, ECG, CADSS, PVT, DSS T, prospective memory task (PMT), and an index of the intensity of the psychedelic effect (MEQ30 , ASC, PPEQ, and subjective description of psychedelic experiences were recorded. Pharmacokinetic analysis of T and bufotenin plasma levels was performed 1 hour and 1 hour after drug administration in Part A. Part B was performed 3 hours after drug administration and 3 hours after drug administration in Part C.

[0137] Participant characteristics: Eighteen participants were recruited for Part A of the study, and four participants were recruited for Part B. Participants were women and 13 were men. The median age was 29 years ( In Part A, four participants were administered 2 mg of 5-MeO-DMT. Six participants were given 6 mg, four participants were given 12 mg, and four participants were given 12 mg. In Part B, one participant received 6 mg of 5-MeO-DMT. Two participants were given 6 mg and then 12 mg, and one participant was given 6 mg and then 12 mg. g, followed by 18 mg.

[0138] result: All participants completed all scheduled visits. In Part A, the inhalation procedure was It was performed properly by 8 of 14 participants, but 2 participants failed to perform the two consecutive inhalations. The entire inhalation volume was inhaled by the same procedure, whereas two participants only inhaled approximately 3 / 4 of the total inhalation volume. In Part B, the inhalation procedure was performed properly by 3 of 4 participants, but 1 Participants achieved adequate inhalation at the first dose level but did not achieve full inhalation at the second dose level. Only about three-quarters of the dose was inhaled. No inhalation-related adverse events were reported.

[0139] The first psychedelic symptoms occurred in all participants within seconds of inhalation. The duration of the psychedelic experience as judged by subjects ranged from 7 to 30 minutes, with a dose-related No association trends were evident.

[0140] Transient, clinically irrelevant increases in heart rate and blood pressure immediately following administration of 5-MeO-DMT No notable changes were observed in vital parameters, except for a rise in blood pressure. The evaluation of the room analysis, CADSS and cognitive tests (PVT, DSST, PMT) was unremarkable. Ta.

[0141] All reported adverse events were mild (except for one moderate event) and all survived to the end of the study. The drug spontaneously disappeared by the end of the study (see Example 3 for Part A, Table 1; see Example 4 for Part B). 3, Table 2). The overall tolerability profile of 5-MeO-DMT was very good. The 18 mg dose group in Part A had the highest number of adverse events, and The only reported symptoms of hallucinations and flashbacks were on days 1 and 7. In Part B, 5-MeO-DMT was administered up to three times daily. Only a few adverse events were reported despite the administration of 18 mg doses (6 mg and following the 12 mg dose), no adverse events were reported.

[0142] [Table 7]

[0143] [Table 8]

[0144] Regarding the intensity of the psychedelic experience as measured by the PPEQ in Part A, Individual questions, total PPEQ score and proportion of patients achieving a peak psychedelic experience Dose-related trends were observed at the 2 mg, 6 mg, and 12 mg dose levels. However, at the 18 mg dose level, this dose-related trend was not significant in response to questions about loss of control. Based on the participants' subjective descriptions, the 18 mg dose level was continued only at 1 mg / kg. The psychedelic experience in the lab produces an altered state of consciousness that occurs very quickly in some participants, but This may explain the observation, given that the memory is so brief ( (Consistent with the so-called "white-out" phenomenon). In Part B, participants were given additional subsequent doses of 12 mg and 18 mg. If participants did not achieve a peak psychedelic experience at the lower dose, all participants It was observed that the intensity of the psychedelic experience increased with increasing dosage. Additionally, one participant received 6 mg, two participants received 12 mg, and one participant received 18 mg. At their individual maximum dose levels of 100 mg, all participants achieved a peak psychedelic experience. At this individual maximum dose level, the individual questions of the PPEQ and the PP The scores for the EQ total score were higher than all dose groups in Part A (Example 3 (Table 3). Individual maximum dose levels required to achieve peak psychedelic experiences. No predictive factors were identified.

[0145] [Table 9]

[0146] Regarding plasma levels of 5-MeO-DMT, in Part A, plasma levels were measured at all doses. However, at 1 hour, the plasma levels of Part A and Part B were already very low. At the 3-hour time point, the lower limit of quantification (LLOQ) of the 5-MeO-DMT assay (0.014 ng / ml) (Example 3, Table 4). Regarding the plasma levels of bufotenin, bufotenin adenosine was administered at 1 hour in three participants. A minimal amount below the LLOQ (0.016 ng / ml) of the assay was observed, whereas bufotenin was undetectable in all other samples.

[0147] [Table 10]

[0148] Summary and conclusion: A. Part A: 5-MeO-DMT dose levels tested at 2 mg, 6 mg, and 12 mg Part B with individual dose escalation, with administration of 5-MeO-DMT up to three times daily The Grand Scheme was well tolerated by all participants, with only a small number of predominantly mild and brief adverse events. Only one adverse event occurred. B. In Part A, the first measurable psychedelic experience occurred at the 2 mg dose level. More pronounced psychedelic experiences and first peak psychedelic experiences were observed with 6 mg A more potent psychedelic experience occurred at the 12mg dose level. However, only two-quarters of participants achieved a peak psychedelic experience. A higher dose of 18 mg given to participants in the outgroup improved psychedelic experience scores and No further increase in the rate of peak psychedelic experiences was observed, which may be due in part to the high dose levels. This may be related to the “white-out” phenomenon in patients with The rate of adverse events when administered intravenously was highest in the 18 mg group in Part A. C. The individual dose escalation regimens applied in Part B shall be consistent with all individual dose levels in Part A. were better, had a higher mean rating of their psychedelic experience, and 4 / 4 of patients achieved their individual maximum One patient who was administered the maximum 18 mg dose in Part B achieved a peak psychedelic experience. Participants did not experience any adverse events, and again the individual dose escalations had a favorable treatment profile and no adverse events. Avoidance of the high doses required is advocated. D. Plasma levels of 5-MeO-DMT were already very low 1 hour after administration and 3 hours later The plasma levels of bufotenin, a metabolite of 5-MeO-DMT, were barely measurable. Levels were barely detectable at 1 hour and undetectable at 3 hours The pharmacokinetic data suggest that the psychedelic effects are short-lived following administration of 5-MeO-DMT. It coincides well with the time.

[0149] In conclusion, the studied dosages, between 2 mg and 18 mg administered by inhalation, It is capable of inducing a psychedelic experience and is available at 6mg, 12mg and 20mg doses administered by inhalation. and 18mg of 5-MeO-DMT produced a psychedelic effect in healthy participants. From Example 2, it was possible to induce a peak psychedelic experience in major depressive disorder. and because of its potential association with treatment benefit in patients diagnosed with other psychiatric disorders. , between 4 mg and 20 mg of 5-MeO-DMT administered by inhalation, especially between 6 mg and 1 Dosages between 1 mg and 8 mg are expected to be therapeutically effective. This individualized dose-escalation regimen may achieve a peak psychedelic experience with good tolerability. This increases the likelihood of treatment with cyclophosphamide, thus providing a superior therapeutic profile compared to administration of a single fixed dose. It will be said.

[0150] [Example 4] The 30-item revised Mystical Experiences Questionnaire (MEQ30) (Barrett FS, J Psychopharmacol. 2 015 Nov;29(11):1182-90) The following questionnaire quantifies the acute psychedelic experience following treatment with 5-MeO-DMT. At the end of the relevant treatment session, the form is given to the patient. and assess the current state of the session at any time using the scales listed below. Participants are then asked to rate the extent to which they have experienced any of the above phenomena. The occurrence of icadelic experiences will be assessed as described based on the scoring instructions.

[0151] Scale: 0 - None; None at all 1-Very slight and cannot be determined 2-Slight 3-moderate 4-Advanced (equivalent in degree to other advanced experiences) 5-Extreme (higher than any other time in life, higher than 4)

[0152] phenomenon: 1. Loss of normal time intervals. 2.Amazing experience. 3. A sense of being unable to adequately express an experience in words. 4. Gaining insightful knowledge experienced on an intuitive level. 5. Feeling of having experienced eternity or infinity. 6. An experience of identity or oneness with objects and / or people perceived in the surroundings. 7. Loss of normal sense of space. 8. Feelings of kindness and calmness. 9. The certainty that one has encountered ultimate reality (what is truly real at any given moment in one's experience) (in that one can "know" and "see" something). 10. The feeling that you cannot do justice to an experience by putting it into words. 11. Loss of normal awareness of where you have been. 12. Feelings of peace and tranquility. 13. A sense of being "outside" time, beyond the past and future. 14. Freedom from the constraints of the personal self and with something perceived as larger than the personal self. Feelings of oneness or union. 15. A sense of being on a spiritual level. 16. The experience of pure being and pure awareness (beyond the world of sense impressions). 17. Ecstatic experiences. 18. The experience of the insight that "all is one." 19. Existing in an area without spatial boundaries. 20. The experience of identity in relation to the inner "inner world." 21. A sense of reverence. 22. The experience of eternity. 23. When reflecting on the experience, did the patient or subject encounter ultimate reality (i.e., what To establish ("know" or "see") that the truth was real. 24. The feeling of having experienced something very sacred and virtuous. 25. Awareness of life or living presence in all things. 26. Experience of merging of the personal self into a larger whole. 27. A sense of being filled with awe or reverence. 28. Experience of oneness with ultimate reality. 29. Feeling that it is difficult to communicate one's experiences to others who have not had similar experiences. 30. Emotions of joy.

[0153] Scoring Instructions: Calculate the mean score (on a scale of 0 to 5) for the phenomena belonging to the subscales listed below. A score for each individual subscale is calculated from the above.

[0154] [Table 11]

[0155] The total score for the MEQ30 was calculated by taking the average response across all phenomena. A score of ≥ 60% of the maximum possible scores on each of the four subscales of the MEQ30 is A patient or subject who meets these criteria is considered to have experienced a "peak psychedelic experience."

[0156] [Example 5] Peak Psychedelic Experience Questionnaire (PPEQ) The Peak Psychedelic Experience Questionnaire (PPEQ) is a questionnaire that measures the psychedelic experience dimension of the ASC and the MEQ30. As an improved alternative, it allows for a more concise and rapid assessment of the intensity of psychedelic experiences. The PPEQ was developed by the inventor to achieve the following: Three questions scored from 0 to 100 by marking a subjective analog scale: 1. How powerful was the experience? 2: To what extent did you lose control? 3. How profound (i.e., deeply salient) was the experience? It consists of:

[0157] The PPEQ total score is the average of the scores for the three questions: "Peak psychedelic experience" " is identified by achieving a PPEQ total score of at least 75. As described in Example 3 In the dataset, the PPEQ total score and the oceanic aspect of the ASC, MEQ30, respectively, A statistically significant correlation between the total score was observed.

[0158] [Example 6] Efficacy of 5-MeO-DMT in major depressive disorder - A hypothetical example from a clinical trial The purpose of this study was to evaluate the efficacy of 5-Me aspirin compared to placebo in improving symptoms of major depressive disorder. The objective of this first study was to determine the efficacy of O-DMT in treating treatment-resistant major depressive disorder. This is being carried out in patients with major depressive disorder, but It is not to be understood that the treatment will have no effect on patients and cannot be used. Clean-in period, randomized double-blind placebo-controlled treatment period, evaluation period and optional open-label period It consists of a follow-up phase with retreatment.

[0159] Screening phase: Patients are selected for study based on a comprehensive set of inclusion and exclusion criteria. Eligibility will be screened by a psychiatrist. Patients will also be informed of the study procedures and medical The effects and potential side effects of the medicine, as well as other potential risks, are explained in detail. Patients confirm their willingness to participate in the study by signing a consent form. The key inclusion criteria were that participants 1) had no psychotic features and were not at increased risk for major depressive disorder; The diagnostic criteria for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) must be met. and 2) had an inadequate response to at least two antidepressants, of which at least One must be in a current depressive episode. ) the patient or a close relative currently or in the past has a DSM-5 diagnosis of a psychotic disorder, 2 ) patients with a history of substance abuse within the past year, 3) previous (recreational) use of 5-MeO-DMT 4) participation in previous clinical studies with other psychedelics; 5) 5-MeO-DMT or Known allergy or hypersensitivity to any of the excipients used in the investigational drug formulation any other contraindications, 6) isocarboxazid, phenelzine, selegiline or tranilo current treatment with a monoamine oxidase inhibitor, such as cypromine, and 7) a positive pregnancy test Sex, lack of adequate contraception.

[0160] Treatment Phase: The study was a double-blind, randomized, randomized, randomized study comparing administration of 5-MeO-DMT with administration of a placebo. This is a randomized, placebo-controlled study. Both compounds will be given by intramuscular injection. DMT is given in the form of its hydrochloride salt and an intramuscular formulation. The dosage of eO-DMT is based on the weight of the free base, whereas the dosage of the hydrochloride salt of 5-MeO-DMT is based on the weight of the free base. It is understood that amounts may be calculated assuming equimolar amounts are used. First, the subjects were admitted to the study site during the study period. reconfirms the patient's eligibility for the study. Second, the subjects were blinded to treatment group assignment. The primary endpoint (Montgomery-Asberg Depression Scale) was assessed by trained raters. baseline mean mean outcome (MADRS total score) and all relevant secondary endpoints Third, instruct the patient on how to administer the drug via intramuscular injection. Fourth, One dose of study drug (5-MeO-DMT or placebo) was administered by intramuscular injection. The starting dose applied in this study was 2 mg of 5-MeO-DMT or placebo. After the injection, the patient should lie down in a comfortable position in a safe environment (e.g., on a mattress on the floor). The onset of psychedelic symptoms was monitored by a research physician and a second trained observer. The effects are expected to occur within minutes of intramuscular administration of 5-MeO-DMT. The usual duration of acute psychedelic symptoms after ingestion is approximately 45-60 minutes. Subjective symptoms After sedation, subjects completed the 30-item Modified Mystical Experiences Questionnaire (MEQ30) and the Supreme Psychedelic Meditation Examination. The intensity of the subjective experience is determined by assessing responses to the Pregnancy and Postpartum Examination Questionnaire (PPEQ). Peak psychedelic experience (the highest possible score on each of the four subscales of the MEQ30) score or a PPEQ total score of at least 75). If this occurs, the patient may be discharged, but no earlier than 2 hours after the last dose. If the high psychedelic experience does not occur, follow the same procedure as for the first dose and repeat with 5-MeO - A higher dose of DMT or placebo, here 5 mg, given 3 hours after the first dose If the peak psychedelic experience is not achieved with any of the above doses and there are intolerable side effects If no effect occurred, a third dose, now 8 mg, was administered after a further interval of 3 hours. This is also fine.

[0161] Evaluation Period: Patients will have follow-up visits on days 7, 14, and 28 after the last dose of study medication. Efficacy and safety assessments will be performed at each of these visits. The endpoint was the change in MADRS total score from baseline to day 7. The key secondary endpoints were sustained response in the MADRS total score at day 28 (MADRS). 50% reduction from baseline in DRS total score) and at 7 and 28 days Changes in 16-item self-report brief depressive symptoms scale (QIDS-SR16) from baseline Further efficacy measures were defined as a MADRS total score of ≤10. Achievement of remission by the Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression-Severity Scale (CGI-S) and Patient Global Impression-Severity Scale (PGI-S), and General All endpoints were assessed in the treatment groups. Each time point will be assessed by an experienced rater blinded to allocation.

[0162] Follow-up period and optional open-label retreatment: After the 28-day visit, patients and physicians The subjects will be unblinded to the relationship of the treatment groups, but will also be assessed for efficacy and Monthly follow-up visits with safety assessments will be conducted. Patients who achieved at least a 50% reduction from baseline in RS total score were included in the blinded phase. Eligible for monthly retreatment for 3 months with 5-MeO-DMT using the maximum administered dose The first retreatment will occur on day 28.

[0163] Analysis: Treatments were compared with the placebo arm as defined by the statistical analysis plan of the study. For the 5-MeO-DMT arm, MADRS total score from baseline to day 7 A study is considered effective if it is possible to detect significant differences in the changes in Analysis of the data may provide further evidence of clinical efficacy.

[0164] [Example 7] Efficacy of 5-MeO-DMT in anxiety disorders - A hypothetical example from a clinical trial The purpose of this study was to evaluate the efficacy of 5-MeO-D compared with an active control in improving symptoms of anxiety disorders. The objective of this first study was to determine the efficacy of MT in patients with treatment-resistant anxiety disorders. This will demonstrate the efficacy of 5-MeO-DMT in treatment-naïve patients with anxiety disorders. This does not mean that the study will have no effect and cannot be used. A randomized controlled trial period, an evaluation period, crossover of participants to other study arms, and Active control treatment and evaluation periods, with optional open-label retreatment and follow-up It consists of the 'p' period.

[0165] Screening phase: Patients are selected for study based on a comprehensive set of inclusion and exclusion criteria. Eligibility will be screened by a psychiatrist. Patients will also be informed of the study procedures and medical The effects and potential side effects of the medicine, as well as other potential risks, are explained in detail. Patients confirm their willingness to participate in the study by signing a consent form. The key inclusion criteria were that participants 1) had social anxiety disorder, generalized anxiety disorder, and / or panic disorder; 1) must meet DSM-5 diagnostic criteria for harm and 2) have at least one appropriate Previous anti-anxiety medications (e.g., selective serotonin reuptake inhibitors), i.e. at least Achieve remission with at least 8 weeks on treatment medication, including 4 weeks of stable medication. have not been able to achieve remission with previous cognitive behavioral therapy or are currently The main exclusion criteria were: 1) patients had to decline cognitive behavioral therapy; 2) a current or past DSM-5 diagnosis of a psychotic disorder in the past 3) previous (recreational) use of 5-MeO-DMT; ) participation in past clinical studies using other hallucinogens, 5) 5-MeO-DMT or midazolam Known allergy or hypersensitivity to the drug or any of the excipients used in the investigational drug formulation sensitivities or other contraindications, 6) isocarboxazid, phenelzine, selegiline or trani current treatment with monoamine oxidase inhibitors such as lixipromine, and 7) pregnancy test Positive, lack of adequate contraception.

[0166] Treatment Phase: The study was a randomized controlled trial comparing administration of 5-MeO-DMT with administration of midazolam. This is a drug-controlled study. 5-MeO-DMT is given by intravenous injection. T is given in the form of its hydrochloride salt and an intravenous formulation. -DMT dosage is based on the weight of the free base, and the dosage of the hydrochloride salt of 5-MeO-DMT is based on the weight of the free base. It is understood that the calculations may be made assuming equimolar amounts are used. The treatment is given by intravenous infusion. Patients are admitted to the study facility in the morning. First, treatment group assignment is performed. A blinded investigator will review the patient's eligibility for the study. The primary endpoint (H1N1) was assessed by experienced assessors blinded to treatment group assignment. Baseline mean score for the HAM-A scale (Heart Anxiety Scale-Anxiety Assessment Measuring Scale-Anxiety Assessment Measuring An ... Third, the study drug is administered intravenously at a starting dose of 1 mg; Midazolam was administered by intravenous infusion over 40 minutes at a dose of 0.045 mg / kg midazolam. After administration of the study drug, the patient is placed in a comfortable position and in a safe environment (e.g., on a mat on the floor). Participants were placed in a lying position on a bed (on a desk) and supervised by the study physician and a second trained observer.

[0167] The onset of psychedelic symptoms in the 5-MeO-DMT group was due to the injection of 5-MeO-DMT. Acute psychiatric symptoms following injection of 5-MeO-DMT are expected to occur within seconds of administration. The usual duration of the derlic symptoms was 5-20 minutes. Subjective symptom relief in both groups Afterwards, participants completed the 30-item Revised Mystical Experiences Questionnaire (MEQ30) and the Peak Psychedelic Experiences Questionnaire. The intensity of the subjective experience is determined by evaluating the responses to the questionnaire (PPEQ). The 5-Me Zolam group may be discharged at this point, but no earlier than 2 hours after the last dose. The O-DMT group scored significantly higher on the peak psychedelic experience (MEQ30) in each of the four subscales. at least 60% of the highest possible score on the test, or a PPEQ total score of at least 75 Patients may be discharged if they experience any of the following symptoms: If no peak psychedelic experience occurs, follow the same procedure as for the first dose and repeat for the fifth dose. A higher dose of -MeO-DMT, here 2 mg, is administered 3 hours after the first dose. If the peak psychedelic experience is not achieved at any of the preceding doses and there are intolerable side effects If this does not occur, a third dose, now 3 mg, may be administered after a further 3 hour interval. stomach.

[0168] Evaluation Period: Patients were followed up on days 1, 7, 14, and 28 after the last dose of study medication. Efficacy and safety assessments will be performed at each of these visits. The endpoint was the change in HAM-A total score from baseline to day 28. The key secondary endpoints were clinical outcome from baseline to days 1, 7, 14, and 28. Patient Global Impression-Improvement (CGI-I) and Patient Global Impression-Improvement (PGI-I) All endpoints were measured in a well-controlled study blinded to treatment group assignment. The results are judged at each stage by a training evaluator.

[0169] Crossover and second evaluation period: Patients were crossed over to the other study arm on day 28. Patients will then receive the treatments of the other study arms and evaluations as described above....

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 or a pharma- ceutically acceptable salt thereof, wherein the 5-MeO-DMT is 5-MeO-DMT or a pharma- ceutical acceptable salt thereof administered by intravenous, intramuscular or subcutaneous routes. The salt is acceptable.

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 1 mg to about 10 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 dosage of about 2 mg, about 5 mg, or about 8 mg is administered, or 5-MeO - 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

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 1 mg to about 3 mg, The second dose is about 4 mg unless the patient has already experienced a peak psychedelic experience. to about 6 mg, after which the patient is already experiencing a peak psychedelic experience. For the third dose, the dose is increased to about 7 mg to about 9 mg unless 5-Me The present invention relates to a method for treating O-DMT comprising administering an equimolar amount of a pharma- ceutically acceptable salt thereof instead of O-DMT. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for the uses described.

14. The first dose of 5-MeO-DMT was about 2 mg and the second dose of 5-MeO-DMT was about 2 mg. and the third dose of 5-MeO-DMT is about 8 mg; or -MeO-DMT is replaced by an equimolar amount of a pharma- ceutically acceptable salt. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof for use as described in 1.

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. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof is administered by intramuscular injection. 5-MeO-DMT or pharma- ceuticals for use according to any one of claims 1 to 17. Acceptable salts thereof.

19. 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 18, The salt is acceptable.

20. 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.

20. The method according to claim 1, wherein the effect of administering the 5. -MeO-DMT or a pharma- ceutically acceptable salt thereof.

21. 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 20, wherein the effect lasts for at least 14 days after the last administration of 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 determined by the method is 5-MeO-DMT or a pharma- ceutically acceptable salt thereof. for the use according to claims 1 to 21, wherein the effect lasts for at least 28 days after the last administration of 5-MeO-DMT or a pharma- ceutically acceptable salt thereof.

23. 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 22, 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.

24. 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.

25. 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 25. 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

26. 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.

27. 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 26 in remission of depressive symptoms or a pharma- ceutically acceptable salt thereof.

28. 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 28. 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.

29. 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 29. The method according to claim 1 , wherein the administration of the salt of said compound is present 14 days after the last administration of said compound. 5-MeO-DMT or a pharma- ceutically acceptable salt thereof.

30. 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 29, in a state of remission of depressive symptoms T or a pharma- ceutically acceptable salt thereof.

31. 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 31. 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.

32. 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 32. The method according to claim 1, wherein the 28th day after the last administration of the salt thereof is 5-MeO-DMT or a pharma- ceutically acceptable salt thereof.

33. 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 32, in a state of remission of depressive symptoms T or a pharma- ceutically acceptable salt thereof.

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