5-methoxy-N,N-dimethyltryptamine (5-MEO-DMT) for treating depression

Abstract

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

Description

[Technical Field]

[0001] The present invention provides a therapeutically effective amount of 5-methoxy-N,N-dimethyltriglyceride to patients who require it. Mental disorders, particularly major depressive disorder, including the administration of ptamine (5-MeO-DMT). Persistent depressive disorder, anxiety disorder, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, This report focuses on improved methods for treating eating disorders and psychoactive substance abuse. [Background technology]

[0002] Hallucinogens are chemical substances, some naturally occurring and some synthetic, that, after ingestion, affect hearing and vision. The ability to induce changes in these things, as well as sensory distortions such as mood and cognitive distortions, in humans. The term hallucinogen is defined as a combination of psychoactive molecules with different modes of action. It encompasses a broad range of conditions. Some mental disorders are, in principle, unresponsive to treatment with psychoactive molecules. It has been suggested that there is. [Overview of the Initiative]

[0003] The present invention provides a therapeutically effective amount of 5-methoxy-N,N-dimethyltriglyceride to patients who require it. Mental disorders, particularly major depressive disorder, including the administration of ptamine (5-MeO-DMT). Persistent depressive disorder, anxiety disorder, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, 5-methoxy-N,N-dimethyl for use in the treatment of eating disorders and psychoactive substance abuse This relates to tiltryptamine (5-MeO-DMT) or pharmaceutically acceptable salts thereof.

[0004] In particular, this invention relates to major depressive disorder, which is treated by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltrip for use in the treatment of patients diagnosed with harm This relates to tamin (5-MeO-DMT) or its pharmaceutically acceptable salts. This disorder is caused by, According to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) published by the American Psychiatric Association A diagnosis may be made. For example, the patient may have 20 or more Montgomery-Asberg depression rating scales. (MADRS) score, or Hamilton Depression Rating Scale (HAM-D) score of 17 or higher. They may have moderate or severe major depressive disorder as indicated by the score. Those with a Montgomery-Asberg Depression Rating Scale (MADRS) score of 35 or higher, Or severe depression as indicated by a Hamilton Depression Rating Scale (HAM-D) score of 25 or higher. The patient may be diagnosed with major depressive disorder. It may be refused.

[0005] Furthermore, patients may experience suicidal ideation, particularly suicidal ideation accompanied by an intention to carry it out. In some cases, they may even be at imminent risk of suicide.

[0006] 5-MeO-DMT or its pharmaceutically acceptable salts are used to induce supreme psychedelic states in patients. It may be administered in a dose or dosage regimen that allows for an experience, approximately 4 mg to approximately 20 mg. A dose of 5-MeO-DMT or an equimolar amount of a pharmaceutically acceptable salt may be administered. Furthermore, the dosage is approximately 6 mg, 12 mg, or 18 mg of 5-MeO-D It may also be MT or an equimolar amount of a pharmaceutically acceptable salt.

[0007] 5-MeO-DMT or a pharmaceutically acceptable salt is administered in the first dose. It may be administered in 0 to 6 subsequent doses, each subsequent dose being given when the patient is at their best. Use a higher dosage than the previous administration unless a psychedelic experience has been experienced.

[0008] Furthermore, 5-MeO-DMT may be administered at a dosage of about 2 mg to about 8 mg for the first administration and thereafter the dosage may be increased to about 8 for the second administration unless the patient has already experienced a peak psychedelic experience mg to about 14 mg, and thereafter the dosage may be increased to about 14 mg to about 20 mg for the third administration unless the patient has already experienced the peak psychedelic experience , an equimolar amount of a pharmaceutically acceptable salt may be administered instead of 5-MeO-DMT . The first dosage of 5-MeO-DMT may be about 6 mg, and the second dosage of 5-MeO-DMT may be about 12 mg, the third dosage of 5-MeO-DMT may be about 1 8 mg, or an equimolar amount of a pharmaceutically acceptable salt may be administered instead of 5-MeO-DMT . .

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

[0010] The occurrence of a peak psychedelic experience can be identified by achieving at least 60% of the maximum possible score on each of the four subscales (Mystical, Positive Mood, Temporal-Spatial Transcendence, and Ineffability) of the 30-item Revised Mystical Experience Questionnaire (MEQ30), and can also be identified by achieving at least 60% of the maximum possible score on the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) Questionnaire, or preferably by achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ). , can be identified by achieving at least 60% of the maximum possible score on each of the four subscales (Mystical, Positive Mood, Temporal-Spatial Transcendence, and Ineffability), and also can be identified by achieving at least 60% of the maximum possible score on the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) Questionnaire, or preferably by achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ). , is identified by achieving 60%, or preferably by achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ). is identified by achieving the total score of the Peak Psychedelic Experience Questionnaire (PPEQ).

[0011] 5-MeO-DMT or a pharmaceutically acceptable salt thereof is preferably administered by inhalation . 5-MeO-DMT or a pharmaceutically acceptable salt thereof may in particular be administered in the form of an aerosol comprising (a) a pharmaceutically acceptable gas, (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DM T) or a pharmaceutically acceptable salt thereof, and the aerosol may have a mass density of aerosol particles of from about 0.5 mg / l to about 12.5 mg / l . The aerosol may be generated by a) exposing a thin layer of 5-MeO-DMT or a pharmaceutically acceptable salt thereof disposed on a solid support to thermal energy, and b) passing air through the thin layer to produce aerosol particles . The aerosol preferably contains 5-MeO-DMT in the form of the free base.

[0012] When administered by inhalation, the dosage of 5-MeO-DMT or a pharmaceutically acceptable salt thereof administered to a patient is preferably inhaled in a single breath.

[0013] The treatments indicated above with 5-MeO-DMT or a pharmaceutically acceptable salt thereof result in a clinical response. This response may be determined by a score of at least "marked improvement" on the Clinical Global Impressions - Improvement (CGI-I) scale or the Patient Global Impressions - Improvement (PGI-I) scale, and the improvement preferably occurs within about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[0014] The clinical response, as determined by a score of at least "marked improvement" on the CGI-I scale or the PGI-I scale, is preferably 5-MeO-DMT or a pharmaceutically acceptable ​​​​​​​At least 6 days after the last dose of the salt, more preferably at least 14 days after the last dose, especially less It will last for at least 28 days.

[0015] Clinical response was also compared to the respective scores before administration of 5-MeO-DMT, MAD This may be determined by an improvement of at least 50% in the RS or HAM-D score. The response is preferably observed after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. It occurs within approximately 2 hours. In addition, a MADRS score of 10 or less or a HAM score of 7 or less. Remission of depressive symptoms as determined by the D score is preferably achieved using 5-MeO-DMT or It occurs approximately two hours after the last pharmaceutically acceptable dose of the salt.

[0016] Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by a 50% improvement, is preferably met by 5-MeO-DMT or drug Until at least 6 days after the last dose of the scientifically acceptable salt, more preferably less It persists for up to 14 days, and especially for at least 28 days.

[0017] Preferably, the MADRS or HAM-D score is compared to the respective score before treatment. A clinical response determined by an improvement of at least 75% in A is 5-MeO-DMT or Seven days after the last administration of the pharmaceutically acceptable salt, more preferably fourteen days later, in particular Furthermore, it is present on day 28. More preferably, the patient is given 5-MeO-DMT or Pharmac. On the 7th day after the last dose of the salt which is generally acceptable, preferably on the 14th day, and especially on the 2nd day. On the 8th day, the diagnosis is made based on a MADRS score of 10 or less or a HAM-D score of 7 or less. The patient is in remission from the depressive symptoms.

[0018] Examples of the present invention include the following: [1] 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in the treatment of patients diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practice. [2] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] above, as the disorder is diagnosed in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) published by the American Psychiatric Association. [3] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] or [2] above, for patients suffering from moderate or severe major depressive disorder as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or more, or by a Hamilton Depression Rating Scale (HAM-D) score of 17 or more items. [4] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [3] above, in which the patient suffers from severe major depressive disorder as indicated by a MADRS score of 35 or higher, or a HAM-D score of 25 or higher. [5] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [4] above, for the patient diagnosed with treatment-resistant major depressive disorder. [6] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [5] above, if the patient also suffers from suicidal ideation. [7] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [6] above, for patients suffering from suicidal ideation accompanied by an intention to carry it out. [8] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [7] above, in cases where the patient is at imminent risk of suicide. [9] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [8] above, administered in a dose or dosage regimen that causes the patient to experience a supreme psychedelic experience.

[10] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [9] above, either administered in doses of approximately 4 mg to approximately 20 mg of 5-MeO-DMT, or administered in equimolar amounts of a pharmaceutically acceptable salt thereof instead of 5-MeO-DMT.

[11] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [9] above, administered in doses of approximately 6 mg, 12 mg, or 18 mg, or administered in equimolar amounts of a pharmaceutically acceptable salt instead of 5-MeO-DMT.

[12] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[10] above, wherein 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in a first dose in a first dose, and 5-MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being higher than the previous dose unless the patient experiences a supreme psychedelic experience.

[13] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[12] above, wherein 5-MeO-DMT is administered in a first dose of approximately 2 mg to approximately 8 mg, then increased to a second dose of approximately 8 mg to approximately 14 mg unless the patient has already experienced a supreme psychedelic experience, then increased to a third dose of approximately 14 mg to approximately 20 mg unless the patient has already experienced a supreme psychedelic experience, or an equimolar amount of a pharmaceutically acceptable salt thereof is administered instead of 5-MeO-DMT.

[14] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in

[13] above, wherein the first dose of 5-MeO-DMT is approximately 6 mg, the second dose of 5-MeO-DMT is approximately 12 mg, the third dose of 5-MeO-DMT is approximately 18 mg, or equimolar amounts of a pharmaceutically acceptable salt thereof are administered instead of 5-MeO-DMT.

[15] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in

[12] to

[14] above, wherein the interval between two doses is between 1 hour and 24 hours, for example, about 2 to 4 hours.

[16] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above in [9]–

[15] , the occurrence of a supreme psychedelic experience is identified by achieving at least 60% of the highest possible score on each of the four subscales of the 30-item Revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive mood, spacetime transcendence and inexpressibility), or by achieving at least 60% of the highest possible score on the Oceanic Feeling (OBN) aspect of the Altered States of Consciousness (ASC) Questionnaire, or by achieving at least the total score of the 75 Supreme Psychedelic Experiences Questionnaire (PPEQ).

[17] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in

[16] above, the occurrence of a supreme psychedelic experience is identified by achieving a total score of at least 75 supreme psychedelic experience questionnaires (PPEQ).

[18] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in any of [1] to

[17] above, administered by inhalation.

[19] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in

[18] above, wherein 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in the form of an aerosol containing (a) a pharmaceutically acceptable gas and (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, the aerosol having a mass density of aerosol particles of about 0.5 mg / l to about 12.5 mg / l.

[20] The aerosol is produced by a) exposing a thin layer of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, which is configured on a solid support, to thermal energy, and b) passing air over the thin layer to produce aerosol particles, wherein the aerosol is produced by a) exposing a thin layer of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, which is configured on a solid support, to thermal energy, and b) passing air over the thin layer to produce aerosol particles.

[21] 5-MeO-DMT for use as described in

[18] ~

[20] above, in the form of a free base.

[22] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in

[18] to

[21] above, wherein the dosage of 5-MeO-DMT or a pharmaceutically acceptable salt thereof administered to the patient is inhaled in a single breath.

[23] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[22] above, wherein a clinical response, as determined by a score of at least “marked improvement” on the Clinical Global Impression-Improvement (CGI-I) score or the Patient Global Impression-Improvement (PGI-I) score, occurs within approximately two hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[24] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[23] above, wherein the clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, persists until at least 6 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[25] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[24] above, wherein the clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, persists until at least 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[26] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[25] above, wherein the clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, persists until at least 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[27] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[26] above, wherein a clinical response is determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective score before treatment, occurring within approximately two hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[28] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[27] above, wherein remission of depressive symptoms, as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, occurs within approximately two hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[29] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[28] above, wherein the clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective score before treatment, persists until at least 6 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[30] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[29] above, wherein a clinical response is present on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores prior to treatment.

[31] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[30] above, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, on the seventh day after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[32] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[31] above, wherein the clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective score before treatment, persists until at least 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[33] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[32] above, wherein a clinical response is present 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores prior to treatment.

[34] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[33] above, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[35] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[34] above, wherein the clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective score before treatment, persists until at least 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[36] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[35] above, wherein a clinical response is present 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores prior to treatment.

[37] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[36] above, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Further aspects of the present invention are defined below in the section on embodiments. [Modes for carrying out the invention]

[0019] Examples of hallucinogenic drugs include tetrahedron, a cannabinoid that acts on cannabinoid receptors. Hydrocannabinol (THC), trace amine-related receptor 1 (TAAR1), and vesicles 3,4-methylenediol, an enteractogen that acts on noamine transporter 2 (VMAT2). Xymethamphetamine (MDMA, "ecstasy") and N-methyl-D-asphalt Ketamine, a dissociative anesthetic that acts as a laminate (NMDA) receptor antagonist, is one example. It can be done.

[0020] Further groups of hallucinogens include lysergic acid diethylamide (LSD), psilocybin, and N , 5-hydroxytryptamine (5-HT) such as N-dimethyltryptamine (DMT) Receptors or serotonin receptors (7 families and 14 types of 5-HT1~5-HT7) Examples include compounds that bind to (subtypes are described). The serotonin production of this latter group These drugs are often referred to as "classic hallucinogens" or "psychedelic drugs," and they induce euphoria. Sensations, trances, transcendence of space and time, spiritual experiences, the breakdown of self-boundaries, or even near-death experiences. This highlights their primary ability to induce qualitative alterations in the state of consciousness, such as sedation and coma. Alternatively, other effects such as overstimulation are minimal.

[0021] Chemically, serotonergic psychedelic drugs are phenylalkylamines or phenylalkylamines. It is one of the doleamines, and the indoleamine class is ergoline and tryptamine. It is divided into two subsets, the latter of which is given by the following formula:

[0022] [ka]

[0023] It is derived from tryptamine, which contains [a specific compound / component].

[0024] Various serotonergic psychedelic drugs affect various serotonin receptors, particularly 5-HT receptors. It has different binding affinity and activation ability for 1A, 5-HT2A, and 5-HT2C. Their activity also targets other targets such as monoamine transporters and trace amine-related receptors. It may be modulated by the interaction of these factors.

[0025] Tryptase found in the South American shrub Psychotria viridis DMT, a type of amine, or syrup, a tryptamine found in over 200 mushroom species. Cyvin, or phenylalanine found in the Uva cactus of the southwestern United States and northern Mexico Naturally occurring psychedelic drugs such as mescaline, a luquilamine, are used in indigenous cultures. It has been used for centuries in ritualistic or socio-cultural contexts, and in religious communion contexts. The use of naturally occurring psychedelic drugs in these environments is considered an unspecified "healing" "These have been considered to be due to their potential, but their potential therapeutic applications for established disease entities" More scientific investigations into this were first explored after the discovery of synthetic ergoline LSD in 1943. .

[0026] These early clinical experiences from the 1950s and 1960s were still relatively methodologically limited. Although the data was weak, promising data showed that, for example, patients who were given LSD along with psychotherapy showed cardiac Alcoholism treatment programs that showed higher rates of moderation or improvement than patients who received only physical therapy. Gram (Jensen SE, QJ Stud Alcohol. 1962; 23:315-20), or supplement to psychotherapy. By administering LSD as an adjunct, over 90% of patients showed "marked improvement" or "improvement." Observation of patients with personality trait confusion or anxiety who obtained the outcome of " (MacLean JR e (t al., QJ Stud Alcohol. 1961; 22:34-45), or approximately 3 minutes in patients treated with LSD. Treatment of patients with terminal cancer in which the following two conditions improved to varying degrees (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 This was reported in tton, New York / London 1969, pp.33-42.

[0027] With the emergence of knowledge about the serotonin system and its role in brain function, researchers And more and more molecular activities of psychedelic drugs are being identified. However, that activity It remains somewhat unclear how this translates into the observed therapeutic effects in mental disorders. Two main concepts were proposed: the first concept was named "psycholistic therapy." Therefore, it is believed that psychedelic drugs administered at low doses promote the relaxation of psychological defense mechanisms, This, when combined with psychotherapy, leads to deep introspective insight and trauma recovery, and subsequently... It emphasized the ability to make the resulting catharsis possible. Therefore, psychology The basic mechanism considered in the combined psychotherapy approach is the activation and deepening of the combined psychotherapy process. Yes, and this required multiple drugs and treatment sessions. The second concept is "psychedelic This was named "derrick therapy," and it involves administering psychedelic drugs in high single doses. It emphasized the ability to induce a "supreme psychedelic experience." A supreme experience is the main It is characterized by the loss of judgment regarding space and time and the collapse of the boundaries of the self, and this is many In this case, a state of bliss, and the feeling of being a complete and harmonious being within the unity of the universe. This leads to experience. Therefore, the basic mechanism considered in the psychedelic approach is psychological. An intuitive perception of integrity and harmony, followed by self-improvement and increased joy of living. And it was meant to bring about a unique and overwhelming experience accompanied by a sense of inner peace.

[0028] Scientific research on the use of psychedelic drugs for the treatment of mental disorders began in the 1960s. Although it developed, the recreational use of these substances also spread rapidly, and psychedelic drugs quickly became mainstream. It was described in the media as an extremely dangerous drug to abuse. It was recognized as a threat to social order. As a result of this awareness, the U.S. Controlled Substances Act of 1970 was passed, and based on this, LSD and other psychedelic drugs Derrick drugs include the most controlled drugs, including those that have no medical use and are considered to have a high potential for abuse. It was classified into the limited category of Schedule 1. For the next 30 years, psychedelic Only very little progress has been made regarding the possible therapeutic use of derrick drugs.

[0029] In recent years, interest in the field of psychedelic therapy has finally begun to rise again. For example, anxiety In 51 cancer patients with and / or mood symptoms, very low levels of psilocybin In a randomized, double-blind, crossover trial comparing a single dose similar to sevofibrillator (SEVEN) with a high single dose, At high doses, clinical indicators and self-assessments of depression, anxiety, or mood disturbances were observed 5 weeks after treatment. This resulted in a significant decrease in the indicators and an increase in the quality of life indicators, and these effects lasted for 6 months. It persisted at that point (Griffiths RR et al., J Psychopharmacol. 2016; 30(12):1181- 1197). A single dose of silobicin and in 29 cancer patients with anxiety and depression In another randomized, double-blind, crossover trial of niacin as a comparator, silosibirs This has resulted in immediate and substantial improvement in anxiety and depression, as well as cancer-related morale loss. Loss and feelings of despair decreased, quality of life improved, and the effects were sustained at a 6.5-month follow-up. It was accompanied by fruit (Ross S et al., J Psychopharmacol. 2016; 30(12):1165-1180). Shirobishi Further positive experiences with treatment-resistant depression (defined in detail in the study) In an open-label study, 20 patients were administered low and high doses of silobicin with a 7-day interval between doses. This occurred in the Luarm feasibility study, and in this trial, at 1 week and 5 weeks after the procedure... 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 is used for obsessive-compulsive disorder (Moreno FA et al., J Clin Psyc hiatry. 2006; 67(11):1735-40) and alcohol dependence (Bogenschutz MP et al., JP Sychopharmacol. 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 It has also been shown to be promising in the treatment of 017; 43(1):55-60). Furthermore, serotonin Regarding the psychedelic drug LSD, 1 In a double-blind, randomized, active placebo-controlled pilot study involving two patients, the following two-month period was observed. Follow-up has been reported to have a significant effect on anxiety indicators (Gasser P et al., JN erv Ment Dis. 2014; 202(7):513-20). Also, monoamine oxidase (MAO) inhibitors Contains the psychoactive agent DMT in combination with certain harmine, harmanine, and tetrahydroharmine. Regarding the shamanistic tea ayahuasca, treatment-resistant major depression (defined in detail in the study) Randomized, double-blind, placebo-versus-all single-dose session in 35 patients with (presumably) In comparative trials, a rapid antidepressant effect was demonstrated compared to placebo (Palhano-Fontes F et al.). al., bioRxiv 103531. 2017; doi: https: / / doi.org / 10.1101 / 103531).

[0030] Based on these results, the inventors believe that the administration of certain serotonergic psychedelic drugs is We believe this has demonstrated that it could be a promising approach for treating various mental disorders. However, at present, no efficacy and safety studies that meet regulatory standards have been conducted, and Psychedelic drugs are not approved by any regulatory authority. Furthermore, currently According to available data, none of the tested drugs achieved remission in all patients. Furthermore, some patients may lose their response after achieving remission, and the drugs tested... It is clear that it still has the problem of associated side effects. Also, for therapeutic use The acute psychedelic effect after oral administration of currently proposed psychedelic drugs lasts for several hours. Furthermore, this is inconvenient for patients and providers and imposes significant limitations on their practical use. For example, treatment resistance published by Carhart-Harris et al. In a study of psilocybin in depression (defined in detail in the research), among 20 patients... Nine patients showed a response at 5 weeks, but three relapsed by 6 months, experiencing anxiety, headaches, and other symptoms. Psychological side effects are frequently reported, along with the acute psychedelic effect of psilocybin lasting approximately 5-6 hours. Based on the duration, monitoring for at least 7 hours after drug administration was required (Ca 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, currently available Compared to other treatments and currently studied psychedelic drugs, the duration of psychedelic effects is... It is beneficial not only for the duration of action to be shortened, but also for the clinical response to manifest more rapidly. It has been suggested that the mental disorders in this department are, in principle, responsive to treatment with psychedelic drugs. Specific disease entities and specific subgroups of disease entities have not yet been identified.

[0031] Therefore, the object of the present invention is to provide a treatment that is more effective than previously described treatments (i.e., (a) clinical a) A higher percentage of patients experience a bed response, b) A greater mean clinical response, c d) improved psychoactive therapy in which clinical response occurs earlier and clinical response is more sustained. The present invention provides compounds for the method and drug regimens for the said therapy. A further objective is to have a better safety profile than previously described treatments and / or compounds for improved psychoactive therapy with good tolerability and for the said therapy The objective of this invention is to provide a drug regimen. Another objective of this invention is to provide a simpler treatment than those previously described. To provide compounds for improved psychoactive therapy and drug regimens for said therapy. Another objective of the present invention is to provide a higher patient compliance rate than previously described treatments. Compounds for improved psychoactive therapy with a success rate (including a higher treatment initiation rate) and The present invention provides a drug regimen for the aforementioned therapy. Certain disease entities and specific disease entities that benefit from improved psychoactive therapies such as The goal is to identify subgroups.

[0032] Mental disorders, particularly major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorder. Currently available for body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse Treatment often involves a limited or insufficient treatment response, a delayed response, and prolonged drug administration. Side effects that limit administration, and in many cases, undesirable medications that limit patient compliance. It is insufficient for the regimen.

[0033] Some of these mental disorders are caused by LSD, psilocybin, and DMT (shamanistic tea ayawa). Recently published cases involving serotonergic psychedelic drugs such as suka Clinical studies suggest that these compounds may be alternatives to currently available treatments. This suggests that... However, even with these drugs, not all patients respond. However, some patients lose their response over time and experience certain side effects. Furthermore, until now The acute psychoactive effects of the tested compounds and drug regimens lasted for several hours after administration. This poses a significant issue of implementation and convenience. Furthermore, the manifestation of clinical responses by these compounds is For example, including patients with very severe symptoms or those at imminent risk of suicide, It is not sufficiently rapid to treat patients with active suicidal ideation accompanied by intent. Finally, some The indications are, in principle, those that respond to treatment with these serotonergic psychedelics. Although this has been shown, specific disease entities and specific subgroups of disease entities have not yet been identified. It hasn't been done.

[0034] Therefore, the technical problem solved by the present invention is that of patients with mental disorders in a broad sense. This proposes improved psychoactive therapy based on the application of serotonergic psychedelic drugs in [the field]. The technical problem is determining the responsiveness to treatment with such improved therapies. This further encompasses the identification of mental disorders and subgroups of mental disorders.

[0035] Most serotonergic psychedelic drugs work primarily through the 5-HT2A receptor. These are thought to mediate the psychoactive effects, but other receptors also play a role, and complete Pharmacology is somewhat complex. Moreover, the relationship between various mental states and specific 5-HT receptor systems is unclear. Since no correlation exists, which specific receptor affinity profile of psychedelic drugs is most... It is not easy to predict whether it will produce the desired therapeutic effect.

[0036] The inventors have discovered that the peak psychedelic state in the acute phase after administration of certain psychedelic drugs The occurrence of the trial is a surrogate behavioral marker for an unknown therapeutic mechanism that is causally or at least underlying. It was recognized that promoting the therapeutic benefits would be one of the following.

[0037] The inventors believe that the relationship between the type and intensity of psychedelic experiences is such that, for example, life-threatening cancer may be present. This is supported by research on depression and anxiety in patients, and in this trial According to Griffiths et al., the nerves immediately after the session following psilocybin administration... The confidential experience score showed a strong correlation with various treatment outcome measures after 5 weeks. This has been reported (Griffiths RR et al., J Psychopharmacol. 2016; 30(12):1181-1197). Furthermore, in cancer patients with anxiety and depression, as reported by Ross et al. Comparative studies have shown that the intensity of subjective mystical experiences during drug exposure is significantly related to clinical benefit. (For example, it was found that there was a causal relationship) (Ross S et al., J Psychopharmacol) . 2016; 30(12):1165-1180). Treatment-resistant depression (defined in detail in the study) In Rosibin's research, the Oceanic Feeling (OBN) (a mystical kind of experience, such as oneness and bliss) (Sharing the experience and characteristics of the state) but the more comprehensive visual and auditory effects of psilocybin However, it was found to have significantly higher predictive power in reducing depressive symptoms (Roseman L et al., Front Pharmacol. 2018; 8:974). Furthermore, according to Bogenschutz et al. In the study of psilocybin in alcohol dependence, the first psilocybin session The intensity of the effect was found to be highly predictive of changes in alcohol consumption during weeks 5-8. (Bogenschutz MP et al., J Psychopharmacol. 2015; 29(3):289-99). Also, John A study by Son et al. on tobacco addiction showed that those who did not smoke after 6 months Those who experienced a relapse showed a significantly higher score on the index of mystical experiences caused by psilocybin compared to those who did not. (Johnson MW et al., J Psychopharmacol. 2014; 28(11):983-92; Garcia- Romeu A, Curr Drug Abuse Rev. 2014;7(3):157-64). In early research on psychedelic drugs, Observations of this kind have already been made, and in this study, for example, alcoholics treated with LSD Among those with alcohol addiction, "50 percent showed a change [that is, they stopped drinking]." Or it improved significantly... In principle, no change was seen in those who had not had transcendent experiences. They continue to drink. However, a significant change is observed in the high percentage of those who have had transcendent experiences. This was reported (citation from Unger SM, Psychiatry. 1963; 26:111-25). In fact, these early This experience further developed the concept of "psychedelic therapy" discussed earlier.

[0038] The inventors have developed a method for long-term clinical improvement in such widespread mental states using acute psychedelia. The main role of the type and intensity of the learning experience is through the so-called resting-state network (RSN). This can be explained by recent observations of the functional connectivity (FC) of the human brain. These RSNs have been shown to be responsible for various aspects of complex cognitive functions, and These interconnected networks are associated with mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety disorders. Harm, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse Furthermore, these conditions may be disrupted in patients who have suicidal ideation, which can occur concurrently with these diseases. It has been discovered.

[0039] The inventors believe that the breakdown of the normal hierarchical structure of RSN is the ultimate common pathway for these diseases. This may explain why many of the diseases involved can occur simultaneously in the same patient. It is believed that there is a possibility. The inventors of the present invention a) psychedelic drugs such as psilocybin, LSD and DMT The administration of cytotoxic drugs can lead to a reduction in binding within specific RSNs (Carhartt-Harr). 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), b) This decrease in the bond correlates with the rating of the peak experience (Carhart-Harris RL et a 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 activities after a peak experience (or normal An increase in (chemical) may be observed (Carhart-Harris RL et al., Sci Rep. 2017; 7(1): 13187), this correlates with d) treatment response (Carhart-Harris RL et al., Sci Rep. 2017; Further instruction (7(1):13187) suggests that the type and intensity of the acute psychedelic experience may be therapeutic. This is thought to explain the observation that it correlates with Utcam.

[0040] The inventors believe that the occurrence of a peak experience is an important mechanism or minor mechanism of the therapeutic efficacy of psychedelic drugs. We recognized that it serves as a surrogate behavior marker for the underlying mechanism, even if it is not present. Therefore, this invention... Those who have had a peak experience compared to previously tested psychedelic drugs and drug regimens To achieve this rapidly, in a higher proportion of patients, and with better reproducibility in individual patients. We recognized that this resulted in a better treatment profile.

[0041] The inventors of this invention use 5-MeO-DMT (see formula below) to induce a supreme experience. The trend is that it is more effective than serotonergic psychedelics previously studied for the treatment of neurological disorders. It was identified as a major serotonergic psychedelic drug, and further based on 5-MeO-DMT. The ultimate experience is the breakdown of the boundaries of the ego and the experience of bliss and / or oneness. It was recognized that this frequently occurs. The inventors also found that 5-MeO-DMT is used in the treatment of neurological disorders. Therefore, it induces peak experiences more rapidly than previously studied serotonergic psychedelic drugs. The inventors recognized that the duration of the psychedelic experience was shorter. -These characteristics of DMT are associated with an improved treatment profile, and 5-MeO-DMT treatment We believe this can be explained by specific changes in RSN activity based on [the following criteria].

[0042] [ka]

[0043] In one embodiment, the present invention relates to mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety disorders. Harm, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse Regarding the use of therapeutically effective doses of 5-MeO-DMT in the treatment of such disorders. The use of therapeutically effective doses of 5-MeO-DMT in such cases is effective for treating disorders and suicidal ideation. This includes the use of therapeutically effective doses of 5-MeO-DMT in patients with suicidal ideation. Treatment in patients with such disorder, including use in patients with treatment-resistant disorder This includes the use of therapeutically effective doses of 5-MeO-DMT. All of these conditions disrupt the activity of the RSN. It is known that this is related to disturbances, and the inventors of this invention have found that this invention can eliminate these conditions using 5-MeO-DM It was recognized that the treatment by T would make the patient responsive.

[0044] In another embodiment, the present invention relates to mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety. Disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. The use of a therapeutically effective dose of 5-MeO-DMT in the treatment thereof, thereby achieving a clinical response This relates to the use that is rapidly achieved after administration of 5-MeO-DMT.

[0045] In another embodiment, the present invention relates to mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety. Disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. The use of a therapeutically effective dose of 5-MeO-DMT in the treatment thereof, thereby achieving a clinical response This concerns the long-term use of 5-MeO-DMT after administration.

[0046] In another embodiment, the present invention relates to mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety. Disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. A novel dosing regimen of 5-MeO-DMT for use in the treatment of patients A novel approach that enables the achievement of a supreme experience with a high percentage of cases and good reproducibility within the same patient. Regarding the medication regimen, it enables a high success rate and the resulting improvement in therapeutic efficacy. In addition to doing so, these new drug regimens also reduce the risk of overdose. , thereby improving the safety profile. Such improved drug regimens, Apply an increased dose of 5-MeO-DMT to the same patient in a subsequent administration on the same day or the following day. It depends on what you do.

[0047] Through each of these embodiments, and especially through combinations thereof, the present invention 1) Improved psychoactive therapy based on the application of psychedelic drugs to patients with mental disorders 1) Provide a method, and 2) certain psychiatric conditions that are responsive to treatment by such improved therapies. This solves the problem of identifying specific subgroups of psychiatric and mental disorders.

[0048] 5-MeO-DMT has a short duration of acute psychedelic effects (for example, oral syrup). Despite improvement (5-20 minutes after inhalation) compared to several hours with cyvin and oral LSD. The fact that it has such therapeutic effects is surprising, but in reality, the short duration of this effect and Absence of associated tolerability (i.e., reduced or lost psychedelic effect after readmission) (Non-existence) is designed to increase the occurrence rate of peak experiences, thereby increasing therapeutic benefits. New medication regimens involving frequent re-administration (more than once a day, or daily, etc.) This is the basis for making it possible. Such repeated administration within a short period of time also carries the risk of overdose. It allows for dose optimization within individuals to reduce serotonin syndrome, and later Physical side effects or degenerative symptoms such as negative psychological reactions including flashbacks of the experience at that time. The memory of the state is weak or nonexistent (so-called "whiteout"), and the meaning is less significant. It can produce a psychedelic experience. Furthermore, by starting with a low dose, patients can Generally, one becomes familiar with psychedelic experiences and prepares for stronger symptoms to occur at higher doses. This can be achieved, and this has a positive impact on experiences at these higher doses. Also, low The prospect of being able to start treatment with a given dose is a sign of patient acceptance of the treatment approach. To encourage recognition and improve overall compliance rates at the patient population level.

[0049] To increase the rate of peak experience and adjust the reproducibility of peak experience, as well as to improve therapeutic effects. Therefore, serotonin production is aimed at reducing side effects and improving compliance rates. Frequent readmission of oral psychedelic drugs was not intended in the prior art, and in practice, readmission has occurred. Delayed onset and long duration of psychedelic effects observed with these current drug regimens Therefore, and tolerability that can be sustained for several days (i.e., low psychedelic effect after re-administration) Due to the rapid onset of (or loss of) symptoms, other psychedelic drugs are currently being tested. This may not be possible with the current administration regimen. Psychedelic drugs used in the treatment situation The previously described drug regimens for this substance are either single doses only or repeated doses only after a few days. The intention is to administer either of the following. Therefore, in these currently applied drug regimens The ultimate experience is not reliably achieved, and those regimens offer the further benefits mentioned above. It brings no benefit.

[0050] 5-MeO-DMT acts as a 5-HT1A and 5-HT2A receptor agonist. It is tryptamine, a naturally occurring serotonergic psychedelic drug. 5-M eO-DMT was first discovered in Dictyoloma incanescens. Although isolated from tree bark, it is also found in other plants, including the Colorado River toad (Bufo alvar). It has been identified as the main active ingredient in the venom of *Ius toad*. Furthermore, 5-MeO-DMT It is synthesized in the human pineal gland and retina and is found in human bodily fluids, including urine, blood, and cerebrospinal fluid. It is released. 5-MeO-DMT is mainly mediated by monoamine oxidase A. It is inactivated by the amination pathway and the cytochrome P450 2D6 (CYP2D6) enzyme. It is O-demethylated by and produces the active metabolite bufotenin. Nin binds to the 5-HT2A receptor with a much higher affinity than 5-MeO-DMT itself. To combine.

[0051] A composition containing 5-MeO-DMT in addition to 5-MeO-DMT and other active components. It has previously only been used in ceremonial or recreational settings (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 In addition, usage patterns, intake motivations, and main factors related to the use of compositions containing 5-MeO-DMT. Recent internet studies aimed at examining the effects, potential benefits, and outcomes The survey revealed that self-reported conditions including anxiety, depression, substance use problems, and post-traumatic stress disorder were present. The majority of respondents with psychological conditions reported an improvement in symptoms related to these disorders. This was explained (Davis AK et al., J Psychopharmacol. 2018 Jul;32(7):779-792). However, As described by the authors, "This study is a cross-sectional study and does not verify psychological symptoms." It lacks established indicators and assessments of past psychological treatments, and includes many multi-substance users. Therefore, causal inference regarding the relationship between the use of 5-MeO-DMT and symptom improvement is limited. Therefore, the relevance of psychological benefits remains observational."

[0052] The application of 5-MeO-DMT in combination with MAO inhibitors enhances and prolongs the drug effect. It can bring about positive effects, but also potentially more toxicity. It is most commonly described in ritual or recreational settings. The administration route for 5-MeO-DMT is inhalation of smoke or vapor or intranasal infusion. However, other routes such as intravenous, rectal, or oral administration are also described, and via the latter route Absorption is likely due to a substantial first-pass effect resulting from the rapid action of MAO enzymes in the intestines and liver. It is restricted by.

[0053] Advantageous effects of the invention The beneficial effects of this invention compared to current standard treatments for each indication include: While not limited to these, a) a higher percentage of patients experiencing a clinical response, b) more a) higher average clinical response, c) earlier onset of clinical response, d) more sustained clinical response, e) more Equivalent or better clinical response with fewer or different side effects, resulting in improved Compliance, and f) simpler treatment regimens including fewer drug doses This includes equivalent or better clinical responses, resulting in improved compliance. Compared to previously studied psychedelic drugs, the present invention, for example, g) acute psychiatric effects after drug administration. Equivalent or better clinical response with a shorter duration of neuroactive effect, resulting in improvement. Convenience and compliance, h) a tendency to achieve the ultimate psychedelic experience Larger, and more reproducible, the ultimate psychedelic experience, while at the same time avoiding unnecessary high doses. Avoid the associated side effects and thereby improve compliance. Further drug regimens can be provided. Furthermore, advantageous effects are defined herein. It should be noted that this is particularly achievable in patients who are resistant to the treatments being performed.

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

[0055] When used in the context of the present invention, the “patient” being treated is the “accepted medical procedure.” The subjects are individuals diagnosed with major depressive disorder by a qualified professional. The diagnosis is, for example, In accordance with the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) published by the American Psychiatric Association i, mental disorders, especially major depressive disorder, persistent depressive disorder, anxiety disorders, post-traumatic stress disorder They may be said to suffer from harm, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder, or psychoactive substance abuse. The diagnosis is made by a physician or psychologist. The human subject themselves identifies one of the disorders. It is insufficient to consider them to be suffering from one of these conditions.

[0056] When used in the context of this invention, "suicidal ideation" means thinking, considering, or planning to commit suicide. This refers to the presence of suicidal ideation in a patient, which is an established professional tool for diagnosing suicidal tendencies. Diagnosis is made by a physician or psychologist using a protocol and method. The patient themselves... It is generally insufficient to consider someone as suffering from suicidal ideation. In some situations, experiencing suicidal ideation is... Patients who do this are considered to be at imminent risk of suicide or to have the "intention to do so". It will be done.

[0057] When used in the context of the present invention, unless otherwise stated, "to treat" and "to treat" The term "treatment" refers to the management of a patient aimed at combating a disease, condition, or disorder. Including care and / or relief of signs and / or symptoms, or disease, condition or disorder The present invention includes the administration and methods of compounds for eliminating the disease.

[0058] When used in the context of the present invention, unless otherwise stated, the term “therapeutic effective dose” refers to the same term. , including the alleviation of signs and / or symptoms of the disease, condition or disorder being treated, researchers , a biological or clinical response pursued by a medical doctor or other clinician in humans This refers to the amount of active compound or pharmaceutical ingredient that induces a reaction.

[0059] "Clinical response" is not limited to these, but also includes the Clinical Global Impression-Severity Scale (CGI-S ), Patient Global Impression-Severity Scale (PGI-S), Clinical Global Impression-Improvement Scale ( The rating scales include the CGI-I or the Patient Global Impression-Improvement Scale (PGI-I). This includes, but is not limited to, improvements in major depressive disorder and persistent depressive disorder. The Montgomery-Asberg Depression Rating Scale (MADRS) or the 17-item Hami Measured by the Luton Depression Rating Scale (HAM-D), for example, the Beck Anxiety Scale (BAI). Hamilton Anxiety Scale (HAM-A) or state-characteristics for anxiety symptoms and anxiety disorders. Anxiety assessment (STAI), post-traumatic stress disorder clinical diagnostic interview. The Capsule Action Scale (CAPS), modified for Body Dysmorphic Disorder (Ale-B) The Rowon College Obsessive-Compulsive Disorder Rating Scale (BDD-YBOCS), and a report on obsessive-compulsive disorder. Brown University Obsessive-Compulsive Disorder Rating Scale (Y-BOCS), weight gain in anorexia nervosa. In addition, the frequency of binge eating and vomiting episodes in bulimia nervosa, and the frequency of binge eating episodes in bulimia nervosa. The frequency of the drug, the duration of restraint or reduction in substance use in psychoactive substance abuse, and Regarding suicidal ideation, suicidal tendency rating scales such as the Columbia Suicide Severity Rating Scale (C-SSRS) are used. The degree or MADRS suicidal thought items, or clinically general impression score - suicidal tendency severity - revised ( CGI-SS-R scale (CGI-SS-R is derived from CGI-S, where 0 = normal, no suicide) No tendency, 1 = suspected suicidal tendencies, 2 = mild suicidal tendencies, 3 = moderate suicidal tendencies, 4 (The scores are as follows: 5 = significant suicidal tendency, 6 = severe suicidal tendency, etc.) Further includes endpoints such as a longer recall period (e.g., typically 7 days in MADRS). Based on endpoints developed for this purpose, at an early point in time after drug administration (e.g., 2 hours) When determining clinical response, reasonable modifications to such endpoints (e.g., MADR) The recall period for S was changed to 2 hours, and sleep items recorded at baseline before drug administration were repeated. The "exceeding" (or "over") may also apply.

[0060] When used in the context of the present invention, unless otherwise stated, "administration" (or "application") The term refers to the distribution of an active compound or pharmaceutical ingredient in any amount, which may be a predetermined quantity, through any pathway. This means introducing the active compound to the patient. Preferably, the active compound is administered nasally by inhalation. It is administered either buccally or sublingually.

[0061] When used in the context of the present invention, unless otherwise stated, "dose" and "administration amount" are used. The term "dosage" refers to the amount of the active compound or pharmaceutical ingredient administered to a patient in each individual dose. It means the amount. The term "dosage regimen" (or "medication regimen") means one or This refers to a predetermined sequence of multiple individual doses.

[0062] As used herein, "aerosol" refers to a gaseous medium (such as air or other pharmaceutically acceptable gases). A stable system consisting of a gas and finely suspended solid and / or liquid particles. It means.

[0063] The term "decomposition product" refers to 5-Me, which is produced as a result of chemical reactions during aerosol formation. This refers to compounds obtained from the chemical modification of O-DMT. Such reactions are not limited to: Oxidation is one example.

[0064] When the percentage of "degradation products" is described in the context of this invention, it refers to the 5 present in the sample. - The amount of MeO-DMT degradation products present in the sample is the amount of 5-MeO-DMT and 5-MeO- Divide by the amount of DMT degradation products added, and multiply by 100%, i.e. ( (Total amount of all 5-MeO-DMT degradation products present in the sample) / ((Presence of all 5-MeO-DMT degradation products in the sample) (Amount of 5-MeO-DMT present) + (Total amount of 5-MeO-DMT present in the sample) This refers to the sum of the amounts of the dissolution products multiplied by 100%.

[0065] As used herein, the term “impurity” refers to 5-MeO-DMT (or drug). This refers to an unwanted compound that contaminates a sample of a chemically acceptable salt. Impurities are aero It may be contained in the starting material before sol formation, or it may be a decomposition product.

[0066] The term "purity" includes all existing 5-MeO-DMT degradation products and all other The percentage of impurities subtracted from 100%, i.e., (100% - (all present) The sum of the amounts of 5-MeO-DMT decomposition products + the sum of all other impurities present (Total) / (Amount of existing 5-MeO-DMT + Total amount of existing 5-MeO-DMT decomposition) This refers to (total amount of product + total amount of all other impurities present) × 100%.

[0067] The term "aerodynamic median of mass" (MMAD) refers to the 50% of the particles present in an aerosol. 0% represents the diameter that is larger than this calculated diameter, and 50% represents the diameter that is smaller.

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

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

[0070] Embodiments of the present invention The present invention provides a therapeutically effective dose of 5-MeO-DMT or pharmaceutically effective dose to a patient as defined herein. This includes administering the salt that is tolerable to mental disorders, particularly major depressive disorder and persistent depression. Pathological disorders, anxiety disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and This concerns improved methods for treating psychoactive substance abuse. Treatment of these disorders is: This definition of having such disorders and suicidal ideation is not limited to those defined herein. This includes the use of 5-MeO-DMT or pharmaceutically acceptable salts thereof in patients. Treatment of the disorder is particularly important for patients as defined herein who have the treatment-resistant disorder mentioned. This includes the use of 5-MeO-DMT or a pharmaceutically acceptable salt thereof in the present invention. When used in relation to pulse, "treatment-resistant" is used in major depressive disorder and persistent depressive disorder. for at least two appropriate courses of pharmacological treatment in the current depressive episode Defined as lacking adequate improvement, anxiety disorders, post-traumatic stress disorder, body dysmorphic disorder and In obsessive-compulsive disorder, at least one appropriate course of pharmacological treatment and at least one psychotherapy session are necessary. It is also defined as a lack of appropriate improvement for a single appropriate process, as well as eating disorders and Psychoactive substance abuse requires at least one appropriate psychotherapy session, with or without pharmacological treatment. It is defined as the absence of appropriate improvement after a thorough process. Whether the improvement is appropriate depends on the clinical assessment. The answer is judged, and whether the treatment process is appropriate is determined by the regimen, dosage, duration, and Compliance is assessed. Appropriateness is determined by a set of predetermined criteria, and by the physician. This is determined and recorded by a psychologist, and the patient themselves may feel that their past treatment process was inappropriate. It is not sufficient to consider that one has not responded appropriately. Appropriateness is retrospective and It may be judged positively.

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

[0072] The disorders preferably treated by the present invention include major depressive disorders, including treatment-resistant types thereof. These include generalized anxiety disorder, obsessive-compulsive disorder, and anorexia nervosa. The present invention most preferably... The disorders that are treated include major depressive disorder, including treatment-resistant forms, and those with suicidal ideation. This includes patients with major depressive disorder.

[0073] In the embodiment, these disorders include treatment-resistant disorders, as well as these disorders accompanied by suicidal ideation. Mental disorders, particularly major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorder. This specification includes, but is not limited to, harm, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse. The dosage of 5-MeO-DMT administered to defined patients is in the range of approximately 1 mg to 25 mg. Any amount within or around the range, preferably about 2 mg to about 20 mg, more preferably about The dosage ranges from 4 mg to approximately 20 mg. Specific useful doses include, for example, approximately 4 mg, 6 mg, and 8 mg. These are approximately 10 mg, 12 mg, 14 mg, 16 mg, 18 mg, and 20 mg. The patient may be treated with an equimolar dose of a pharmaceutically acceptable salt of 5-MeO-DMT. In this specification, when a range such as "about 1 mg to about 25 mg" is described, the inventors of this invention Some of them will be mentioned in detail, but the intention is to consider all individual values ​​within that range, Please note that for the sake of brevity, not all of them will be mentioned.

[0074] In preferred embodiments, these disorders include treatment-resistant disorders and those accompanied by suicidal ideation. Mental disorders, including major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorders. Having stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder and psychoactive substance abuse, An improved method for treating patients as defined herein with a therapeutically effective dose of 5-MeO-DMT The method involves the occurrence of a clinical response within approximately two hours after administration of 5-MeO-DMT.

[0075] In preferred embodiments, these disorders include treatment-resistant disorders and those associated with suicidal ideation. Mental disorders such as disabilities, especially major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorder. This person has Tress syndrome, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. Improved method for treating patients as defined in the specification with a therapeutically effective dose of 5-MeO-DMT The method involves 5-MeO-DMT, including clinical responses that occurred within approximately 2 hours after administration of 5-MeO-DMT. Until at least about 6 days after the last dose of O-DMT, preferably the last dose of 5-MeO-DMT. The last dose of 5-MeO-DMT is administered at least approximately 14 days after subsequent doses, more preferably within 14 days of the last dose. This includes sustained clinical response for at least approximately 28 days after the initial diagnosis.

[0076] In preferred embodiments, these disorders include treatment-resistant disorders and those associated with suicidal ideation. Mental disorders such as disabilities, especially major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorder. This person has Tress syndrome, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. Improved method for treating patients as defined in the specification with a therapeutically effective dose of 5-MeO-DMT The method involves administering doses greater than a single dose of 5-MeO-DMT.

[0077] In a preferred embodiment, a dose greater than a single dose of this 5-MeO-DMT is 1 or It is administered to the patient in multiple treatment blocks, each block consisting of 2 to 7 doses, and each treatment The interval between each administration within a block is approximately 1 hour to 24 hours, and the end of one treatment block. The interval between the completion of one treatment block and the start of the next treatment block is approximately 6 days or more.

[0078] In a more preferred embodiment, a larger dose of this 5-MeO-DMT than a single dose It is administered to the patient in one or more treatment blocks, each block consisting of 1 to 3 doses. The interval between each administration within each treatment block is approximately 24 hours, and the end of one treatment block is followed by the next. The interval between the start of the treatment block is approximately 6 days or more.

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

[0080] In the embodiment, each administration and each treatment block is administered to individual patients. The dosage of 5-MeO-DMT administered is constant for each individual patient, ranging from approximately 1 mg to approximately 25 mg, preferably about 2 mg to about 20 mg, more preferably about 4 mg to about 20 mg Select. Useful specific amounts are, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about The dosages are 12 mg, approximately 14 mg, approximately 16 mg, approximately 18 mg, and approximately 20 mg.

[0081] In a preferred embodiment, the dosage of 5-MeO-DMT administered to individual patients is determined by each patient. The first dose within the block is selected from approximately 2 mg to 8 mg, and then progresses to 20 mg. Either the earlier of the two, all doses within that treatment block are administered. It increases with each subsequent dose within each treatment block.

[0082] In a more preferred embodiment, the administration of 5-MeO-DMT to individual patients. The dosage is selected from approximately 2 mg to 8 mg for the first dose within each treatment block, followed by 20 The dose reaches mg, or all doses within that treatment block are administered, or the patient The individual may experience a supreme psychedelic experience, or the supervising physician may observe side effects. Each treatment until it is determined that further dose increases are inappropriate, whichever comes first. It increases with each subsequent dose within the block.

[0083] In embodiments where the dosage increases with subsequent administrations, the dosage of the next administration is equal to the dosage of the previous administration. Add approximately 2 mg to approximately 10 mg, preferably approximately 4 mg to approximately 8 mg, most preferably approximately 6 mg. It is determined by the amount. For example, if the dosage of the first administration is 6 mg, the dosage increases If the dose is 6 mg, the second dose will not be administered unless one of the aforementioned discontinuation criteria is met. The drug dose is 12 mg. Preferably, the dose for the third administration is 18 mg.

[0084] In a preferred embodiment, 5-MeO- is administered to individual patients in each treatment block. The dosage of DMT is selected from approximately 2 mg to 8 mg for the first dose, and then the patient's dosage... Unless you have already experienced a supreme psychedelic experience within the treatment block, or if the supervising physician Unless it is determined that further dose increases are inappropriate based on observed side effects, For the second dose, the dosage is selected from approximately 8 mg to approximately 14 mg, and for the third dose, approximately 1 The dosage is increased to a selection of 4 mg to approximately 20 mg. (First, second, and third doses) Useful specific doses include, for example, about 6 mg, about 12 mg, and about 18 mg.

[0085] In a more preferred embodiment, the administration of 5-MeO-DMT to individual patients. The dosage for the first dose of the first treatment block is selected from approximately 2 mg to approximately 8 mg, and then 2 The dose reaches 0 mg, or all doses in that treatment block are administered, or The patient experiences a peak psychedelic experience, or the supervising physician observes side effects. Up to the earlier of the two decisions that a further increase in dose is deemed inappropriate, the first The dose increases with each subsequent dose within the treatment block, up to the maximum dose in the first treatment block. The amount is for all subsequent treatment blocks and administration within those subsequent treatment blocks. It is used as a dosage. For example, the maximum dose in the first treatment block is the amount the patient receives. If the dose was 18mg because you experienced a supreme psychedelic experience at that dose, all subsequent The dose for administration within the treatment block and subsequent treatment blocks is 18 mg. be.

[0086] In the 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 approximately 2 mg to approximately 8 mg, and then the patient... Unless you have already experienced a supreme psychedelic experience within the treatment block, or under the supervision of a physician Unless it is determined that further dose increases are inappropriate based on the observed side effects, For the second dose of the first treatment block, the dosage is selected from approximately 8 mg to approximately 14 mg. For the third administration of the first treatment block, the dosage is selected from approximately 14 mg to approximately 20 mg. The dose is increased to the maximum dose in the first treatment block, and the maximum dose in all subsequent treatment blocks It is used as the dosage for administration within the block of treatments and their subsequent procedures. A useful specific dose for the first, second, and third doses in the treatment block is, for example, about 6 mg. These are approximately 12 mg and 18 mg.

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

[0088] According to the present invention, 5-MeO-DMT is preferably administered together with an MAO inhibitor. No.

[0089] The occurrence of a "peak psychedelic experience" in a patient is identified by achieving at least 60% of the maximum possible score on each of the four subscales of the 30-item Revised Mystical Experience Questionnaire (MEQ30) (mystical, positive mood, transcendence of time and space, and ineffability) , as described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90, with the score items shown in Example 4. This can be implemented, and the score items are as set forth in Example 4. The occurrence of a "peak psychedelic experience" in a patient may also be identified by achieving at least 60% of the maximum possible score on the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) questionnaire

[0090] The occurrence of a "peak psychedelic experience" in a patient may also be identified by achieving a score of at least 75 on the total Peak Psychedelic Experience Questionnaire (PPEQ) score , which is the average of the patient's 0-100 scored responses to the following three questions: 1. How powerful was the experience? 2. To what extent did you lose control? 3. How profound (i.e., deeply significant) was the experience? The occurrence of a "peak psychedelic experience" in a patient may also be identified by achieving a score of at least 75 on the total Peak Psychedelic Experience Questionnaire (PPEQ) score

[0091] The occurrence of a "peak psychedelic experience" in a patient may also be identified by achieving a score of at least 75 on the total Peak Psychedelic Experience Questionnaire (PPEQ) score , which is the average of the patient's 0-100 scored responses to the following three questions: 1. How powerful was the experience? 2. To what extent did you lose control? 3. How profound (i.e., deeply significant) was the experience? The occurrence of a "peak psychedelic experience" in a patient may also be identified by achieving a score of at least 75 on the total Peak Psychedelic Experience Questionnaire (PPEQ) score , which is the average of the patient's 0-100 scored responses to the following three questions: 1. How powerful was the experience? 2. To what extent did you lose control? 3. How profound (i.e., deeply significant) was the experience? , which is the average of the patient's 0-100 scored responses to the following three questions: 1. How powerful was the experience? 2. To what extent did you lose control? 3. How profound (i.e., deeply significant) was the experience?

[0092] A therapeutically effective amount of 5-MeO-DMT is administered by inhalation, by nasal administration, by buccal administration, or by sublingual administration. Administration via these routes can ensure a rapid onset of action. The most preferred administration route is administration by inhalation. Pre Administration via these routes can ensure a rapid onset of action. The most preferred administration route is administration by inhalation. Pre In other words, the therapeutically effective dose of 5-MeO-DMT is inhaled in a single breath.

[0093] For intranasal administration, 5-MeO-DMT is administered as a neat substance or in the form of a nasal administration formulation. It may also be used in this form, and these examples are well known in the art. For nasal administration, 5-Me O-DMT is available as a pharmaceutically acceptable salt or in the form of a pharmaceutically acceptable salt formulation. It may be used. Examples of suitable devices are known in the art.

[0094] For buccal or sublingual administration, 5-MeO-DMT is administered either by itself or in a formulation, for example. It is used in the form of tablets, films, sprays, and creams, and examples of these are known in the art. Furthermore, when administered buccally or sublingually, the pharmaceutically acceptable dosage of 5-MeO-DMT is... The salt can be used in itself or in formulations commonly known in the art, such as tablets, films, It may be used in the form of a spray or cream.

[0095] Administration is particularly by inhalation of aerosols. Such aerosols are (a) drugs Scientifically acceptable gases, (b) 5-methoxy-N,N-dimethyltryptamine (5-Me The aerosol particles contain O-DMT) or a pharmaceutically acceptable salt thereof, and the aerosol is approximately 0.5 mg / l to approximately 12.5 mg / l, preferably approximately 1.3 mg / l to approximately 10 mg / l. In particular, it has a mass density of aerosol particles of approximately 2 mg / l to approximately 9 mg / l. Pharmaceutically acceptable. The gas used is preferably air.

[0096] Aerosol particles preferably contain less than 1 wt% impurities, particularly less than 0.5 wt% impurities. It contains, and they are further preferably produced as a result of chemical reactions during aerosol formation. obtained by chemical modification of 5-MeO-DMT, contains less than 0.5 wt% of 5-MeO-D MT decomposition products, particularly less than 0.2 wt% of 5-MeO-DMT decomposition products.

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

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

[0099] The aerosol is preferably characterized by an aerodynamic mass median diameter of less than 3 microns and greater than 0.1 microns, particularly an aerodynamic mass median diameter of less than 2 microns and greater than 0.1 microns .

[0100] The aerosol may be formed by a) exposing a thin layer of 5-MeO-DMT or a pharmaceutically acceptable salt thereof disposed on a solid support to thermal energy, and b) passing air over the thin layer of 5-MeO-DMT to generate aerosol particles. The thin layer may be formed by passing air over the thin layer to produce aerosol particles. The thin layer may have a thickness of less than about 10 μm, particularly less than about 7.5 μm. The thin layer may have a thickness in the range of about 0.1 μm to about 10 μm, particularly in the range of about 0.3 μm to about 7.5 μm.

[0101] The thin layer of 5-MeO-DMT disposed on the solid support may be exposed to thermal energy via the air passing over the thin layer. Alternatively, the thin layer of 5-MeO-DMT disposed on the solid support may be exposed to thermal energy via the solid support. The thin layer of MT may be exposed to thermal energy through the solid support.

[0102] The air passing over the thin layer may have a temperature in the range of about 180°C to about 260°C. The air passing over the thin layer The air passing over may have a temperature of approximately 210°C and travels at a speed of approximately 12 L / min for approximately 15 seconds. It may pass through a thin layer over the duration in between.

[0103] Aerosol particles are contained in volumes of approximately 3 liters or less, particularly in volumes of approximately 2 to 3 liters. It may be used. Aerosols are especially intended for therapeutic use. Aerosols are Preferably, it is delivered to the patient in a single inhalation.

[0104] This invention relates to a form of 5-MeO-DMT or pharmaceutically acceptable 5-MeO-DMT suitable for inhalation in a medical setting. The present invention aims to provide a salt of which 5-Me is used in particular in aerosol form. We provide O-DMT and pharmaceutically acceptable salts thereof. These aerosols are therapeutically effective. Suitable for administering an effective dose of aerosol to a patient in a single inhalation. It has the mass density of aerosol particles.

[0105] Aerosols useful in this invention can be formed using thermal energy. When using energy to form aerosols of compounds, especially when the aerosols pass through the lungs of patients When used for whole-body delivery of the compound, what conditions are safe, efficient, and predictable air? Predicting suitability for rosolation is extremely difficult. In this context, the relevant variables are... Therefore, a) the dosage of the compound, and b) the morphology of the compound so that it can be used for aerosolization. c) the state (e.g., crystalline form or thin layer form), and the thermal energy to which the compound is exposed. The amount of ghee (defined by the temperature and duration of exposure) and d) the generation of aerosols The volume of air introduced for this purpose (defined by the airflow rate and duration) It can be listed.

[0106] This invention relates to the administration of 5-MeO-DMT or pharmaceutically acceptable salts thereof to patients by inhalation. The objective is to provide compositions and methods for safe, efficient, and predictable whole-body delivery. Yes. "Safe" means that the aerosol particles contain very few impurities and 5-MeO-DMT degradation products. It means that it should contain only a certain amount, and "efficient" means that the dosage is up to a predetermined level and is favorable. This means that the aerosol is almost completely or completely aerosolized, and that the aerosol is mainly in the alveoli. Systemic delivery of 5-MeO-DMT or its pharmaceutically acceptable salts via the lungs through absorption. It has desirable physical properties, and the aerosol is absorbed in a single inhalation (i.e., 1 (Within a few deep breaths) it means that it can be inhaled by the patient, and "predictable" means decomposition There is little to no variation in the quantity of the product, the degree of aerosolization, and the physical properties of the aerosol. It means that it should not happen.

[0107] A suitable aerosol is a) a therapeutically effective amount of 5-MeO-DMT as a thin layer on a solid support. a) a thin layer of 5-MeO-DMT for a short duration relative to controlled heating Intermittent exposure, and c) providing a controlled amount of air so that an aerosol is formed. It may be achieved by doing so.

[0108] The composition for delivering a therapeutically effective dose of 5-MeO-DMT may include an aerosol. a) The aerosol is heated by thermal energy by a) a thin layer of 5-MeO-DMT constructed on a solid support. by exposure to and by passing air over a thin layer of 5-MeO-DMT The aerosol is formed and has the following characteristics: 1) an aerodynamic mass median diameter of less than 3 microns Therefore, it contains aerosol particles characterized by 2) less than 1 wt% impurities and 0. Contains aerosol particles characterized by less than 5% 5-MeO-DMT degradation products. 3) Having one or more that can be delivered to the patient in a single inhalation.

[0109] The volume of aerosol that can be delivered to a patient in a single inhalation is 3 microns or less. Characterized by the full aerodynamic mass median diameter, with less than 1 wt% impurities and 0.5% The generation of aerosol particles having less than 5-MeO-DMT drug degradation products is due to a) 5-Me a) Dosage of 5-MeO-DMT contained in a thin layer of O-DMT, b) 5-MeO-DMT c) Thickness of the thin layer, the thermal energy to which the 5-MeO-DMT thin layer is exposed (exposure temperature and (defined by duration) and d) air passing over a thin layer of 5-MeO-DMT By defining the total amount (defined by the airflow rate and duration of the airflow) It will be achieved.

[0110] Preferably, the 5-MeO-DMT thin layer allows thermal energy to pass through the air passing over the thin layer. When exposed to this, the air is heated. The heated air passing over the thin layer reaches approximately 180°C. The temperature may be in the range of approximately 260°C. The air passing over the thin layer is particularly warm at approximately 210°C. It may have a degree.

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

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

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

[0114] Solid supports to which 5-MeO-DMT or a pharmaceutically acceptable salt thereof is provided vary It may have any shape. Examples of such shapes include, without limitation, a diameter of 1.0 mm. Cylinders smaller than 1.0 mm thick, boxes with a thickness of less than 1.0 mm, and small sizes (e.g., less than 1.0 mm in size) This includes substantially all shapes that can be permeated by the pores. Preferably, a solid support. This is due to a large surface-to-volume ratio (e.g., greater than 100 per meter) and large surface This results in a mass-to-weight ratio (for example, greater than 1 cm² per gram).

[0115] A solid support structure of one shape can also be transformed into another shape with different properties. For example, a flat sheet with a thickness of 0.25 mm has approximately 8,000 surface areas per meter. It has a volume ratio. By rolling the sheet into a hollow cylinder with a diameter of 1 cm, the height of the original sheet is It maintains a high surface-to-mass ratio, but has a lower surface-to-volume ratio (approximately 400 per meter). A support is fabricated.

[0116] Numerous different materials are used to construct a solid support structure. Examples of materials include, but are not limited to, metals, inorganic materials, carbon materials, and polymers. The following are examples of material classes: aluminum, silver, gold, stainless steel, copper, and tan. Gusten; silica, glass, silicon and alumina; graphite, porous carbon, carbide Bon yarn and carbon felt; polytetrafluoroethylene and polyethylene Recall. Combinations of materials and modified materials with coatings are also used.

[0117] When aluminum is used as a solid support, aluminum foil is a suitable material. As an example of silica, alumina, and silicon-based materials, amorphous silica S-5631 (Sigma, St. Louis, Missouri), BCR171 (Aldrich, Missouri) Alumina with a predefined surface area greater than 2 m² / g, manufactured in St. Louis, and for the semiconductor industry. Examples of silicon wafers used in this process include carbon yarn and carbon felt. Available from American Kynol, Inc., New York City, New York. be.

[0118] Preferably, the thickness of the thin layer of 5-MeO-DMT constructed on a solid support is about 10 μm. Less than approximately 7.5 μm. Thin layers are in the range of approximately 0.1 μm to approximately 10 μm, especially 0 It may have a thickness in the range of 0.3 μm to 7.5 μm.

[0119] Preferably, the total amount of air passing over the thin layer of 5-MeO-DMT is about 6 liters per minute. Tolls ~ between approximately 40 liters per minute, preferably approximately 8 liters per minute ~ The flow rate is approximately 16 liters, and the total volume of the aerosol does not exceed approximately 3 liters. The duration of the airflow is preferably selected to be between approximately 2 and 3 liters. This is how it is defined. For example, with an airflow rate of approximately 6 liters per minute, the duration of the airflow is It should be less than approximately 30 seconds. A useful specific airflow rate and duration is approximately per minute. 12 liters and approximately 15 seconds, which results in a volume of approximately 3 liters of aerosol. It is made. Another useful specific airflow rate and duration is 10 liters per minute and This takes about 15 seconds, which results in a volume of approximately 2.5 liters of aerosol. A useful specific airflow rate and duration are 8 liters per minute and approximately 15 seconds. This results in an aerosol volume of approximately 2 liters. Another useful specific airflow The duration is 10 liters per minute and about 12 seconds, which is about 2 liters The volume of the aerosol in Toll is obtained.

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

[0121] The aerosol concentration is approximately 0.5 mg / l to approximately 12.5 mg / l, preferably approximately 1.3 mg / l. It has a mass density of aerosol particles of approximately 10 mg / l, particularly between approximately 2 mg / l and 9 mg / l. ru.

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

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

[0124] The composition for delivering a therapeutically effective dose of 5-MeO-DMT may include an aerosol. a) 12 mg of aerosol configured as a thin layer less than 5 microns thick on a solid support. The dosage of 5-MeO-DMT is applied to a thin layer of heated air for a duration of 15 seconds. Formed by exposure to a temperature of 210°C through passage, the aerosol is as follows: Characteristics: 1) Aerosol particles characterized by an aerodynamic mass median diameter of less than 3 microns. 2) Contains less than 1% impurities and less than 0.5 wt% 5-MeO-DMT degradation. 3) Contains aerosol particles characterized by the product, which can be administered to a patient in a single inhalation. Having one or more that can be delivered.

[0125] Those skilled in the art, who are familiar with the characteristics and aerosolization conditions of the aerosols defined in this invention, must To identify a suitable vaporization device or system that delivers the desired aerosol characteristics. This can be done. Examples of such suitable vaporization devices or systems include, for example, drip. Volcano Medic Vapor with accompanying medication capsules with pads Zation System (Storz & Bickel, Germany; e.g., European Patent No. 0) Specification No. 933093 and European Patent No. 1884254 and Community Registered Design 0 (Disclosed in 03387299-0001) and Staccato devices (Ale XZA Pharmaceuticals, Mountain View, USA; for example, the United States U.S. Patent No. 7,458,374, U.S. Patent No. 9,370,629 and U.S. Examples include those disclosed in Specification No. 9,687,487.

[0126] The generated aerosol is collected in a balloon and inhaled by the patient through the balloon. good.

[0127] The patient may also receive psychotherapy intervention.

[0128] In certain embodiments, the disorder being treated is major depressive disorder. In this particular embodiment, the patient may suffer from treatment-resistant major depressive disorder. The patient may also suffer from suicidal ideation accompanied by the intention to carry it out, and the risk of suicide may be imminent. It may be considered to be in the same particular embodiment, having major depressive disorder, The dosage of 5-MeO-DMT administered to patients as defined herein is approximately 4 mg to approximately 20 mg. The dose is in the range of mg and administered by inhalation. In this particular embodiment, 5-Me Useful specific amounts of O-DMT include, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about The doses are 12 mg, approximately 14 mg, approximately 16 mg, approximately 18 mg, and approximately 20 mg. The patient also, The patient may be treated with an equimolar dose of a pharmaceutically acceptable salt of 5-MeO-DMT.

[0129] In certain embodiments, the disorder being treated is major depressive disorder. In this particular embodiment, the patient may suffer from treatment-resistant major depressive disorder. The patient may also suffer from suicidal ideation accompanied by the intention to carry it out, and the risk of suicide may be imminent. It may be considered to be in the same particular embodiment, having major depressive disorder, The dosage of 5-MeO-DMT administered to patients as defined herein is approximately 4 mg to approximately 20 mg. The dose is in the range of mg and administered by inhalation. In this particular embodiment, 5-Me Useful specific amounts of O-DMT include, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about These are 12 mg, approximately 14 mg, approximately 16 mg, approximately 18 mg, and approximately 20 mg. In this embodiment, MADR is compared to each score before administration of 5-MeO-DMT. Clinical response as determined by at least a 50% improvement in the S or HAM-D score, This is determined to be at least a "marked improvement" score in the CGI-I or PGI-I score. The clinical response observed occurs within approximately two hours after administration of 5-MeO-DMT.

[0130] In certain embodiments, the disorder being treated is major depressive disorder. In this particular embodiment, the patient may suffer from treatment-resistant major depressive disorder. The patient may also suffer from suicidal ideation accompanied by the intention to carry it out, and the risk of suicide may be imminent. It may be considered to be in the same particular embodiment, having major depressive disorder, The dosage of 5-MeO-DMT administered to patients as defined herein is approximately 4 mg to approximately 20 mg. The dose is in the range of mg and administered by inhalation. In this particular embodiment, 5-Me Useful specific amounts of O-DMT include, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about These are 12 mg, approximately 14 mg, approximately 16 mg, approximately 18 mg, and approximately 20 mg. In this embodiment, a MADRS score of 10 or less or a HAM-D score of 7 or less is used. Remission of depressive symptoms occurs approximately two hours after administration of 5-MeO-DMT.

[0131] In certain embodiments, the disorder being treated is major depressive disorder. In this particular embodiment, the patient may suffer from treatment-resistant major depressive disorder. The patient may also suffer from suicidal ideation accompanied by the intention to carry it out, and the risk of suicide may be imminent. It may be considered to be in the same particular embodiment, having major depressive disorder, The dosage of 5-MeO-DMT administered to patients as defined herein is approximately 4 mg to approximately 20 mg. The dose is in the range of mg and administered by inhalation. In this particular embodiment, 5-Me Useful specific amounts of O-DMT include, for example, about 4 mg, about 6 mg, about 8 mg, about 10 mg, about These are 12 mg, approximately 14 mg, approximately 16 mg, approximately 18 mg, and approximately 20 mg. In this embodiment, clinical responses such as those occurring within approximately 2 hours after administration of 5-MeO-DMT, Compare the respective scores of MADRS or HAM-D before administration of 5-MeO-DMT. Clinical response as determined by an improvement of at least 50% in the score, or CGI-I or A clinical response that is judged as at least a "marked improvement" score on the PGI-I score is 5 -MeO-DMT until at least about 6 days after the last dose, preferably 5-MeO-DM Until at least approximately 14 days after the last dose of T, more preferably until the last dose of 5-MeO-DMT. The effect lasts for at least approximately 28 days after administration.

[0132] In certain embodiments, the disorder being treated is major depressive disorder. In this state, the amount of 5-MeO-DMT administered to individual patients is the amount of the first treatment block. The first dose is selected from approximately 2 mg to 8 mg, and then the patient reaches the desired level within that treatment block. Unless you have already had a high-psychedelic experience, or if your supervising physician has observed any side effects Unless it is determined that further dose increases are inappropriate based on the first treatment block The second dose is selected from approximately 8 mg to approximately 14 mg, and the first treatment block For the third dose of the drug, the dosage is increased to a dose selected from approximately 14 mg to approximately 20 mg, and the first dose of the drug is increased to a dose selected from approximately 14 mg to approximately 20 mg. The maximum dose in the treatment block is for all subsequent treatment blocks and their subsequent It is used as the dosage for administration within the treatment block. Useful specific doses for the first, second, and third administrations are, for example, about 6 mg, about 12 mg, and about The dose is 18 mg. In this same particular embodiment, the interval between each dose in the first treatment block is The time is approximately 3 hours. In this particular embodiment, 5-MeO-DMT is administered by inhalation. In this particular embodiment, the occurrence of the supreme psychedelic experience is due to 30 items. The four subscales of the Revised Mystical Experiences Questionnaire (MEQ30): Mystical, Positive Mood, Spatiotemporal. At least 60% of the highest possible score in each of the transcendence and inexpressibility. Achieved (as described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90), and This requires achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ). That will identify them.

[0133] Furthermore, in certain embodiments, the disorder being treated is major depressive disorder. In the embodiment, the dosage of 5-MeO-DMT administered to individual patients in each treatment block The dosage is selected from approximately 2 mg to 8 mg for the first dose, and then the patient uses the treatment block. Unless you have already experienced a supreme psychedelic experience within the group, or under the supervision of a physician Unless it is determined that further dose increases are inappropriate based on side effects, a second dose is given. The dosage is selected from approximately 8 mg to approximately 14 mg, and the third dose is approximately 14 mg to approximately The dosage is increased from 20 mg to a selected dose. In the first treatment block, the first and second The useful specific doses for the third dose are, for example, about 6 mg, about 12 mg, and about 18 mg. In this particular embodiment, the interval between each administration within each treatment block is approximately 3 hours. The interval between the end of one treatment block and the start of the next treatment block is approximately 6 days. In the same specific embodiment, 5-MeO-DMT is administered by inhalation. In this embodiment, the occurrence of a supreme psychedelic experience is determined by a 30-item revised mystical experience questionnaire ( The four subscales of the MEQ30 (mystical, positive mood, transcendence of space and time, and inexpressibility) Achieving at least 60% of the highest possible score in each of the following (Barrett FS, J Ps) As described in ychopharmacol. 2015;29(11):1182-90, or at least 75 supreme Identified by achieving a total score on the Psychedelic Experience Questionnaire (PPEQ).

[0134] In certain embodiments, the disease being treated is treatment-resistant major depressive disorder. In a particular embodiment, the patient may suffer from suicidal ideation accompanied by the intention to carry it out, and the intention to commit suicide It may be considered to be at imminent risk. In this same particular embodiment, individual patients The dosage of 5-MeO-DMT administered is approximately 2 mg for the first dose of the first treatment block. Selected from approximately 8 mg, the patient then experiences a supreme psychedelic state within that treatment block. Unless already experienced, or based on the supervising physician's observation of side effects, further dose increases are not permitted. Unless it is determined that the addition is inappropriate, the second dose of the first treatment block should be approximately 8 mg. The dosage is selected from approximately 14 mg, and the third dose of the first treatment block is approximately 1 The dosage is increased to a selected dose from 4 mg to approximately 20 mg, in the first treatment block. The maximum dose is for all subsequent treatment blocks and the administration within those subsequent treatment blocks. It is used as the dosage for the first, second and third treatment blocks. Useful specific doses for administration are, for example, about 6 mg, about 12 mg, and about 18 mg. In this particular embodiment, the interval between each administration within the first treatment block is approximately 3 hours. In the same specific embodiment, 5-MeO-DMT is administered by inhalation. In this embodiment, the occurrence of a supreme psychedelic experience is determined by a 30-item revised mystical experience questionnaire ( The four subscales of the MEQ30 (mystical, positive mood, transcendence of space and time, and inexpressibility) Achieving at least 60% of the highest possible score in each of the following (Barrett FS, J Ps) As described in ychopharmacol. 2015;29(11):1182-90, or at least 75 supreme Identified by achieving a total score on the Psychedelic Experience Questionnaire (PPEQ).

[0135] Furthermore, in certain embodiments, the disease being treated is treatment-resistant major depressive disorder. In the same particular embodiment, 5-MeO- is administered to individual patients in each treatment block. The dosage of DMT is selected from approximately 2 mg to 8 mg for the first dose, and then the patient's dosage... Unless you have already experienced a supreme psychedelic experience within the treatment block, or if the supervising physician Unless it is determined that further dose increases are inappropriate based on observed side effects, For the second dose, the dosage is selected from approximately 8 mg to approximately 14 mg, and for the third dose, approximately 1 The dosage is increased to a selected dose from 4 mg to approximately 20 mg. 1. Useful specific doses for the second and third doses are, for example, about 6 mg, about 12 mg and about 1 The dose is 8 mg. In this particular embodiment, the interval between each dose within each treatment block is approximately 3 This is a time interval, and the time between the end of one treatment block and the start of the next treatment block is approximately 6 days. Yes. In this particular embodiment, 5-MeO-DMT is administered by inhalation. In the same specific embodiment, the occurrence of the supreme psychedelic experience is due to the 30 revised mystical scriptures. The four subscales of the MEQ30 questionnaire (mysticism, positive mood, transcendence of space and time, and Achieving at least 60% of the highest possible score in each of the (Barrett) categories. (As described in t FS, J Psychopharmacol. 2015;29(11):1182-90), or at least Identified by achieving a total score on the 75 Supreme Psychedelic Experience Questionnaires (PPEQ) ru.

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

[0137] The present invention, in the embodiments and claims described herein, means that "the patient is treated." 5-methoxy-N,N-dimethyltryptamine (5MeO-DMT) for use in Change phrases such as "5-methoxy-N,N-dimethyl" or "a pharmaceutically acceptable salt thereof" to "5-methoxy-N,N-dimethyl Treatment of patients with liptamine (5MeO-DMT) or a pharmaceutically acceptable salt thereof By replacing it with "method of placement", it further encompasses all treatment methods defined. It is recognized.

[0138] A clinical response occurs a) within a specific time period, b) lasts at least until a specific time period. or c) "After the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof" Embodiments and claims that are described as existing at a specific point in time are subject to the terms of other embodiments and claims. Through the substance, for example a) “last dose” is actually 5-MeO-DMT or pharmaceutical a) the first dose of the salt that is permissible for the patient, and b) the “last dose” is actually the patient Experience the ultimate psychedelic experience with 5-MeO-DMT or its pharmaceutically acceptable salt. The administration is the first dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. However, a higher dose than the first dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof may be used. This may also be a subsequent administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. It is emphasized that the embodiments and claims include the following.

[0139] Embodiments relating to the treatment of major depressive disorder 1. Diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine (5) for use in the treatment of patients -MeO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a score of 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS). By, or by the Hamilton Depression Rating Scale (HAM-D) score of 17 or more items. The use of Embodiment 1 or 2 in a person suffering from moderate or severe major depressive disorder as indicated below. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 4. The patient is diagnosed with a MADRS score of 35 or higher, or a HAM-D score of 25 or higher. For use in the person suffering from severe major depressive disorder as shown in Embodiment 3, 5-MeO- DMT or a pharmaceutically acceptable salt thereof. 5. When the patient is diagnosed with treatment-resistant major depressive disorder, the use described in Embodiments 1-4 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9. Administered in a dose or dosage regimen that induces the patient to experience a peak psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable so for use as described in Embodiments 1 to 8 Salt. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air over the thin layer and, by producing aerosol particles, the use described in Embodiment 19 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use described in Embodiments 1 to 26 occurs within approximately 2 hours after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Determined by a MADRS score of 28.10 or less or a HAM-D score of 7 or less. Remission of depressive symptoms with the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-27 occurs within approximately 2 hours thereafter. Or a pharmaceutically acceptable salt thereof. 29. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable duration of the salt persists for at least 6 days after the last dose, as described in Embodiments 1-28. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 30. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The salt present on the 7th day after the last dose of the acceptable salt, as described in Embodiments 1-29. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 31. If the patient has been 7 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof The condition is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-DM for use in embodiments 1-30 in a state of remission of depressive symptoms T or a pharmaceutically acceptable salt thereof. 32. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists for at least 14 days after the last dose, as in Embodiments 1-31. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 33. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1-32, present on the 14th day after the last dose of the salt, is acceptable. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 34. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the result is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use in embodiments 1 to 33, in a state of remission of depressive symptoms MT or its pharmaceutically acceptable salt. 35. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists for at least 28 days after the last dose, as in Embodiments 1-34. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 36. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1 to 35, present on the 28th day after the last dose of the salt that is permissible. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 37. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the result is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use in embodiments 1 to 36, in a state of remission of depressive symptoms MT or its pharmaceutically acceptable salt. For use as described in Embodiments 1 to 37, administered in 38.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 39. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 38 salt. 40. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 38-39, including administration of the salt This is the pharmaceutically acceptable salt. 41. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 38-40. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 42. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 38-41, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 43. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 38 or 42, including the Pharmacopoeia That salt is generally acceptable. 44,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur, item 30. The four subscales of the Revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive mood, time) At least 60 of the highest possible scores in each of the following categories: transcendence of space and inexpressibility. Identified by the achievement of % or by the Oceanic Perception (OBN) of the Altered States of Consciousness (ASC) Questionnaire. ) Identified by achieving at least 60% of the highest possible score on the surface, the first treatment block The interval between the two doses in the course is approximately 1 hour or more and approximately 24 hours or less, and the second and any subsequent doses The subsequent treatment block is administered during the first treatment block, and the drug is 5-MeO-DMT or other medication. A single dose of the maximum scientifically acceptable dose of the salt, followed by a block of subsequent treatments, is performed. The treatment block is administered at least about 6 days after the block, as described in Embodiments 1 to 37. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 45,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will be less likely. This is determined by achieving a total score on the 75 Supreme Psychedelic Experience Questionnaires (PPEQ). Furthermore, the interval between the two administrations during the first treatment block is approximately 1 hour or more and approximately 24 hours or less. And, a second and any subsequent treatment block is administered during the first treatment block, 5- A single dose comprising the maximum dose of MeO-DMT or a pharmaceutically acceptable salt thereof, followed by Embodiment 1: The treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~37.

[0140] Embodiments relating to the treatment of persistent depressive disorder 1. In accordance with accepted medical practices, a qualified professional will diagnose persistent depressive disorder. 5-methoxy-N,N-dimethyltryptamine for use in the treatment of diagnoses (5-MeO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a score of 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS). By, or by the Hamilton Depression Rating Scale (HAM-D) score of 17 or more items. For use according to Embodiment 1 or 2, for persons suffering from moderate or severe depression as indicated. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 4. The patient is diagnosed with a MADRS score of 35 or higher, or a HAM-D score of 25 or higher. For use in the person suffering from severe depression as shown in Embodiment 3, 5-MeO-DMT or its pharmaceutically acceptable salt. 5. Use according to Embodiments 1-4 in which the patient is diagnosed with treatment-resistant persistent depressive disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9. Administered in a dose or dosage regimen that induces the patient to experience a peak psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable so for use as described in Embodiments 1 to 8 Salt. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air over the thin layer and, by producing aerosol particles, the use described in Embodiment 19 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use described in Embodiments 1 to 26 occurs within approximately 2 hours after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Determined by a MADRS score of 28.10 or less or a HAM-D score of 7 or less. Remission of depressive symptoms with the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-27 occurs within approximately 2 hours thereafter. Or a pharmaceutically acceptable salt thereof. 29. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable duration of the salt persists for at least 6 days after the last dose, as described in Embodiments 1-28. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 30. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The salt present on the 7th day after the last dose of the acceptable salt, as described in Embodiments 1-29. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 31. If the patient has been 7 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof The condition is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-DM for use in embodiments 1-30 in a state of remission of depressive symptoms T or a pharmaceutically acceptable salt thereof. 32. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists for at least 14 days after the last dose, as in Embodiments 1-31. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 33. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1-32, present on the 14th day after the last dose of the salt, is acceptable. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 34. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the result is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use in embodiments 1 to 33, in a state of remission of depressive symptoms MT or its pharmaceutically acceptable salt. 35. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists for at least 28 days after the last dose, as in Embodiments 1-34. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 36. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1 to 35, present on the 28th day after the last dose of the salt that is permissible. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 37. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the result is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use in embodiments 1 to 36, in a state of remission of depressive symptoms MT or its pharmaceutically acceptable salt. For use as described in Embodiments 1 to 37, administered in 38.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 39. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 38 salt. 40. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 38-39, including administration of the salt This is the pharmaceutically acceptable salt. 41. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 38-40. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 42. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 38-41, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 43. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 38 or 42, including the Pharmacopoeia That salt is generally acceptable. 44,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 37 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 45,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-37 .

[0141] Implementations for the Treatment of Anxiety Disorders 1. Patients diagnosed with anxiety disorder by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine (5-Me) for use in the treatment of patients O-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a Beck Anxiety Scale (BAI) score of 19 or higher or a Hamilton Anxiety Scale score of 15 or higher. Embodiment 1: A person suffering from moderate or severe anxiety as indicated by the HAM-A anxiety scale score. Alternatively, 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. 4. The patient is indicated by a BAI score of 30 or higher, or a HAM-A score of 24 or higher. For those suffering from severe anxiety, 5-MeO-DMT or drug for use as described in Embodiment 3 That salt is scientifically acceptable. 5. Patient diagnosed with treatment-resistant anxiety disorder, 5 for use according to Embodiments 1-4 -MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air through the thin layer, Aerosol particles are produced by creating aerosol particles for use as described in Embodiment 19. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 50% improvement, is considered acceptable with 5-MeO-DMT or pharmaceutically acceptable. The use described in Embodiments 1 to 26 occurs within approximately 2 hours after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. Determined by a BAI score of 28.9 or less, or by a HAM-A score of 7 or less. Remission of anxiety symptoms is achieved with the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DM for use as described in Embodiments 1 to 27 occurs within approximately 2 hours after administration. T or a pharmaceutically acceptable salt thereof. 29. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 50% improvement, is considered acceptable with 5-MeO-DMT or pharmaceutically acceptable. The effects of the salt described in Embodiments 1 to 28 persist until at least 6 days after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 30. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 75% improvement, is met by 5-MeO-DMT or pharmaceutically acceptable The salt present on the 7th day after the last dose is used for the purposes described in Embodiments 1-29. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 31. If the patient has been 7 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof Anxiety disorders in the eyes, as determined by a BAI score of 9 or less or a HAM-A score of 7 or less. 5-MeO-DMT or for use according to Embodiments 1-30 in a state of remission of the condition That salt is pharmaceutically acceptable. 32. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 50% improvement, is considered acceptable with 5-MeO-DMT or pharmaceutically acceptable. The effects of the salt lasting for at least 14 days after the last dose, as described in Embodiments 1-31. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 33. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 75% improvement, is met by 5-MeO-DMT or pharmaceutically acceptable For the use described in Embodiments 1-32, the salt present on the 14th day after the last dose is used. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 34. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], anxiety is assessed by a BAI score of 9 or less or a HAM-A score of 7 or less. 5-MeO-DMT for use in the manner of Embodiments 1-33, in a state of symptom remission This is the pharmaceutically acceptable salt. 35. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 50% improvement, is considered acceptable with 5-MeO-DMT or pharmaceutically acceptable. The effects of the salt lasting for at least 28 days after the last dose, as described in Embodiments 1-34. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 36. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 75% improvement, is met by 5-MeO-DMT or pharmaceutically acceptable For the use described in Embodiments 1 to 35, the salt present on the 28th day after the last dose is used. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 37. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], anxiety is assessed by a BAI score of 9 or less or a HAM-A score of 7 or less. 5-MeO-DMT for use in the manner of Embodiments 1-36, in a state of symptom remission This is the pharmaceutically acceptable salt. For use as described in Embodiments 1 to 37, administered in 38.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 39. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 38 salt. 40. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 38-39, including administration of the salt This is the pharmaceutically acceptable salt. 41. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 38-40. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 42. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 38-41, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 43. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 38 or 42, including the Pharmacopoeia That salt is generally acceptable. 44,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 37 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 45,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-37 .

[0142] Embodiments relating to the treatment of post-traumatic stress disorder 1. In accordance with accepted medical practices, post-traumatic stress disorder is diagnosed by a qualified professional. 5-methoxy-N,N-dimethyltryptamine for use in the treatment of diagnoses (5-MeO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient took the Post-Traumatic Stress Disorder Clinical Diagnostic Interview Scale (CAPS-5) for DSM-5. The severity of the condition is indicated by a total score of 23 or more out of 20 severity items, resulting in moderate, severe, or extreme symptoms. 5-MeO-DMT for use in patients suffering from post-traumatic stress disorder, as described in Embodiment 1 or 2. Or a pharmaceutically acceptable salt thereof. 4. The patient's severity is indicated by a total score of 35 or higher across the 20 severity items of the CAPS-5. 5-MeO for use in patients suffering from severe or extreme post-traumatic stress disorder as described in Embodiment 3 - DMT or a pharmaceutically acceptable salt thereof. 5. Use of the embodiments described in Embodiments 1-4 when the patient is diagnosed with treatment-resistant post-traumatic stress disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air through the thin layer, Aerosol particles are produced by creating aerosol particles for use as described in Embodiment 19. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. Compared to the pre-treatment score, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 30% improvement, is determined by 5-MeO-DMT or pharmaceutically... Uses of the salt described in Embodiments 1-26, which occur within approximately 7 days after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 28. The severity is determined by a total score of 10 or less on the 20 severity items of CAPS-5. Remission of symptoms of post-traumatic stress disorder is achieved with 5-MeO-DMT or pharmaceutically acceptable drugs. 5 for use as described in Embodiments 1-27, which occurs within approximately 7 days after the last dose of the salt. -MeO-DMT or a pharmaceutically acceptable salt thereof. 29. Compared to the score before treatment, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 30% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists until at least 14 days after the last dose, as in Embodiments 1-28. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 30. Compared to the score before treatment, the total score of the 20 severity items of CAPS-5 is lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The salt present on the 7th day after the last dose of the acceptable salt, as described in Embodiments 1-29. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 31. If the patient has been 7 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof The severity of the eye is determined by a total score of 10 or less on the CAPS-5 severity scale, which comprises 20 severity items. For use in embodiments 1 to 30, in a state of remission of symptoms of post-traumatic stress disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 32. Compared to the score before treatment, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 30% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists until at least 21 days after the last dose, as in Embodiments 1-31. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 33. Compared to the pre-treatment score, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1-32, present on the 14th day after the last dose of the salt, is acceptable. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 34. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the severity is determined by a total score of 10 or less on the CAPS-5 scale, which comprises 20 severity items. For use in a state of remission of symptoms of post-traumatic stress disorder, as described in Embodiments 1 to 33 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. Compared to the score before treatment, the total score of the 20 severity items of CAPS-5 is lower. A clinical response, judged by at least a 30% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists for at least 28 days after the last dose, as in Embodiments 1-34. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 36. Compared to the pre-treatment score, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1 to 35, present on the 28th day after the last dose of the salt that is permissible. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 37. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the severity is determined by a total score of 10 or less on the CAPS-5 scale, which comprises 20 severity items. For use in a state of remission of post-traumatic stress disorder symptoms, as described in Embodiments 1 to 36 5-MeO-DMT or a pharmaceutically acceptable salt thereof. For use as described in Embodiments 1 to 37, administered in 38.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 39. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 38 salt. 40. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 38-39, including administration of the salt This is the pharmaceutically acceptable salt. 41. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 38-40. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 42. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 38-41, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 43. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 38 or 42, including the Pharmacopoeia That salt is generally acceptable. 44,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 37 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 45,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-37 .

[0143] Embodiments relating to the treatment of body dysmorphic disorder 1. Diagnosed with body dysmorphic disorder by a qualified professional in accordance with accepted medical procedures. 5-methoxy-N,N-dimethyltryptamine (5-) for use in the treatment of patients MeO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. Patients with body dysmorphic disorder completed the modified Yale-Brown University Obsessive-Compulsive Disorder Rating Scale. Moderate or severe body dysmorphic disorder as indicated by a score of 31 or higher on the (BDD-YBOCS) scale. For use in the embodiment 1 or 2, 5-MeO-DMT or pharmaceutical The salt that is permissible. 4. The patient has severe body dysmorphic disorder, as indicated by a BDD-YBOCS score of 41 or higher. For those suffering from the condition, 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiment 3 That salt. 5. For use as described in Embodiments 1-4, when the patient is diagnosed with treatment-resistant body dysmorphic disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air through the thin layer, Aerosol particles are produced by creating aerosol particles for use as described in Embodiment 19. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. An improvement of at least 30% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DM for use as described in Embodiments 1-26 occurs within approximately 7 days after administration. T or a pharmaceutically acceptable salt thereof. 28. Symptoms of body dysmorphic disorder as determined by a BDD-YBOCS score of 16 or less. Remission occurs within approximately 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically for use as described in Embodiments 1 to 27 occurs in 5-MeO-DMT or pharmaceutically The salt is acceptable. 29. An improvement of at least 30% in the BDD-YBOCS score compared to the pre-treatment score indicates The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-M for use according to Embodiments 1-28, which lasts for at least 14 days after administration. eO-DMT or a pharmaceutically acceptable salt thereof. 30. An improvement of at least 50% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-29, present on day 7 after administration or its pharmaceutically acceptable salt. 31. If the patient has been 7 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof The eyes show symptoms of body dysmorphic disorder, as determined by a BDD-YBOCS score of 16 or less. 5-MeO-DMT or pharmaceuticals for use in the manner of Embodiments 1-30 in a state of remission That salt is generally acceptable. 32. An improvement of at least 30% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-M for use according to embodiments 1-31, which lasts for at least 21 days after administration. eO-DMT or a pharmaceutically acceptable salt thereof. 33. An improvement of at least 50% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-32, present on day 14 after administration. Or a pharmaceutically acceptable salt thereof. 34. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], symptoms of body dysmorphic disorder are determined by a BDD-YBOCS score of 16 or less. 5-MeO-DMT or drug for use according to Embodiments 1-33 in a state of remission That salt is scientifically acceptable. 35. An improvement of at least 30% in the BDD-YBOCS score compared to the pre-treatment score indicates The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-M for use according to embodiments 1-34, which lasts for at least 28 days after administration. eO-DMT or a pharmaceutically acceptable salt thereof. 36. An improvement of at least 50% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-35, present on day 28 after administration. Or a pharmaceutically acceptable salt thereof. 37. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], symptoms of body dysmorphic disorder are determined by a BDD-YBOCS score of 16 or less. 5-MeO-DMT or drug for use according to Embodiments 1-36 in a state of remission That salt is scientifically acceptable. For use as described in Embodiments 1 to 37, administered in 38.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 39. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 38 salt. 40. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 38-39, including administration of the salt This is the pharmaceutically acceptable salt. 41. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 38-40. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 42. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 38-41, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 43. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 38 or 42, including the Pharmacopoeia That salt is generally acceptable. 44,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 37 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 45,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-37 .

[0144] Embodiments relating to the treatment of obsessive-compulsive disorder 1. Diagnosed with obsessive-compulsive disorder by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine (5-M) for use in patient treatment eO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a score of 26 or higher on the Yale-Brown University Obsessive-Compulsive Disorder Rating Scale (Y-BOCS). The patient suffers from moderate or severe obsessive-compulsive disorder as indicated by the core, as described in Embodiment 1 or 2. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 4. The patient suffers from severe obsessive-compulsive disorder, as indicated by a total score of 35 or higher on the Y-BOCS scale. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Embodiment 3. . 5. For use according to Embodiments 1-4, when the patient is diagnosed with treatment-resistant obsessive-compulsive disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air through the thin layer, Aerosol particles are produced by creating aerosol particles for use as described in Embodiment 19. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. Determined by an improvement of at least 35% in the YBOCS score compared to the score before treatment. The clinical response observed is approximately [number missing] after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or for use as described in Embodiments 1-26, occurring within 7 days That salt is pharmaceutically acceptable. 28. Remission of symptoms of obsessive-compulsive disorder, as determined by a YBOCS score of 12 or less, is 5 - Occurs within approximately 7 days after the last dose of MeO-DMT or a pharmaceutically acceptable salt thereof. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 27 That salt. 29. Determined by an improvement of at least 35% in the YBOCS score compared to the score before treatment. The clinical response observed is less severe after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-D for use as described in Embodiments 1-28, which lasts for at least 14 days. MT or its pharmaceutically acceptable salt. 30. Determined by an improvement of at least 50% in the YBOCS score compared to the score before treatment. A clinical response is observed 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals present on day 1 for use as described in Embodiments 1-29 That salt is generally acceptable. 31. If the patient has been 7 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof In the eyes, remission of obsessive-compulsive disorder symptoms, as determined by a YBOCS score of 12 or less. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 30 That salt. 32. Determined by an improvement of at least 35% in the YBOCS score compared to the score before treatment. The clinical response observed is less severe after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-D for use as described in Embodiments 1-31, which lasts for at least 21 days. MT or its pharmaceutically acceptable salt. 33. Determined by an improvement of at least 50% in the YBOCS score compared to the score before treatment. The clinical response observed is 1 dose after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day 4, 5-MeO-DMT or drug for use as described in Embodiments 1 to 32 is present. That salt is scientifically acceptable. 34. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of obsessive-compulsive disorder symptoms as determined by a YBOCS score of 12 or less. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 33 The salt that is used. 35. Determined by an improvement of at least 35% in the YBOCS score compared to the score before treatment. The clinical response observed is less severe after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-D for use as described in Embodiments 1-34, which lasts for at least 28 days. MT or its pharmaceutically acceptable salt. 36. Determined by an improvement of at least 50% in the YBOCS score compared to the score before treatment. The clinical response observed is 2 minutes after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or drug for use according to Embodiments 1-35, present on day 8. That salt is scientifically acceptable. 37. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of obsessive-compulsive disorder symptoms as determined by a YBOCS score of 12 or less. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 36 The salt that is used. For use as described in Embodiments 1 to 37, administered in 38.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 39. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 38 salt. 40. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 38-39, including administration of the salt This is the pharmaceutically acceptable salt. 41. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 38-40. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 42. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 38-41, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 43. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 38 or 42, including the Pharmacopoeia That salt is generally acceptable. 44,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 37 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 45,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-37 .

[0145] Embodiments relating to the treatment of anorexia nervosa 1. Diagnosed with anorexia nervosa by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine for use in the treatment of patients ( 5-MeO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient weighed 17 kg / m². 2 Moderate, severe, or extreme body mass index (BMI) is indicated by a BMI of less than a certain value. 5-MeO-D for use in the embodiment 1 or 2 for patients suffering from severe anorexia nervosa MT or its pharmaceutically acceptable salt. 4. The patient weighs 16 kg / m². 2Severe or extreme nervous appetite, indicated by a body mass index of less than a certain percentage. For use in patients suffering from anorexia, 5-MeO-DMT or pharmaceutically acceptable as described in Embodiment 3. The salt that is used. 5. The use of the embodiments described in Embodiments 1-4 in which the patient is diagnosed with treatment-resistant anorexia nervosa. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air through the thin layer, Aerosol particles are produced by creating aerosol particles for use as described in Embodiment 19. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Compared to the body mass index before administration of 27.5-MeO-DMT, the body mass index was at least 1 kg / m 2 The clinical response, as determined by an increase in 5-MeO-DMT or pharmaceutically acceptable Use according to embodiments 1 to 26, which occurs within approximately 28 days after the last dose of the salt to be tolerated. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 28. At least 18.5 kg / m³ 2 Anorexia nervosa, as determined by the body mass index. Remission occurred approximately 56 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-27, occurring within 24 hours That salt is generally acceptable. Compared to the body mass index before administration of 29.5-MeO-DMT, the body mass index was at least 1 kg / m 2 The clinical response, as determined by an increase in 5-MeO-DMT or pharmaceutically acceptable The effects of the salt being tolerated persist for at least 56 days after the last dose, as described in Embodiments 1-28. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Compared to the body mass index before administration of 30.5-MeO-DMT, the body mass index was at least 1 kg / m 2 The clinical response, as determined by an increase in 5-MeO-DMT or pharmaceutically acceptable The salt present on the 28th day after the last dose of the salt used in the embodiments described in Embodiments 1 to 29 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 31. The patient has 56 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day 1, at least 18.5 kg / m 2 Anorexia nervosa, determined by the body mass index. 5-MeO-DMT or for use according to Embodiments 1-30 in a state of remission of the disease That salt is pharmaceutically acceptable. For use as described in Embodiments 1 to 31, administered in 32.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 33. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 32 salt. 34. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 32-33, including administration of the salt This is the pharmaceutically acceptable salt. 35. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 32-34. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 36. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use according to embodiments 32-35, which is between 24 hours and more. MT or its pharmaceutically acceptable salt. 37. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 32 or 36, including the Pharmacopoeia That salt is generally acceptable. 38,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 31 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 39,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-31 .

[0146] Embodiments relating to the treatment of bulimia nervosa 1. Diagnosed with bulimia nervosa by a qualified professional in accordance with accepted medical procedures. 5-methoxy-N,N-dimethyltryptamine (5-) for use in the treatment of patients MeO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient exhibits moderate or severe bulimia nervosa, characterized by four or more episodes of binge eating and vomiting per week. For use in individuals suffering from bulimia nervosa, 5-MeO-DMT for use as described in Embodiment 1 or 2. Or a pharmaceutically acceptable salt thereof. 4. Severe bulimia nervosa, characterized by 8 or more episodes of binge eating and vomiting per week. For those suffering from the disease, 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiment 3. That salt. 5. For use as described in Embodiments 1-4, when the patient is diagnosed with treatment-resistant bulimia nervosa. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air through the thin layer, Aerosol particles are produced by creating aerosol particles for use as described in Embodiment 19. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Compared to the number of binge eating and vomiting episodes per week prior to administration of 27.5-MeO-DMT, Clinical assessment is made by a reduction of at least 50% in the number of binge eating and purging episodes per week. The response occurred within approximately 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically for use as described in Embodiments 1 to 26 The salt is acceptable. 28. Symptoms of bulimia nervosa are determined by 0 episodes of binge eating and vomiting per week. Remission occurs approximately 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 27, which occur within The salt that is permissible. Compared to the number of binge eating and vomiting episodes per week prior to administration of 29.5-MeO-DMT, Clinical assessment is made by a reduction of at least 50% in the number of binge eating and purging episodes per week. The response was at least the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-28, which lasts for up to 14 days. This is the pharmaceutically acceptable salt. Compared to the number of binge eating and vomiting episodes per week prior to administration of 30.5-MeO-DMT, Clinical assessment is made by a reduction of at least 75% in the number of binge eating and purging episodes per week. The response is present on day 7 after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 29. The salt that is used. 31. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Symptoms of bulimia nervosa are determined by zero episodes of binge eating and vomiting per week. 5-MeO-DMT or drug for use according to Embodiments 1-30 in a state of remission That salt is scientifically acceptable. Compared to the number of binge eating and vomiting episodes per week prior to administration of 32.5-MeO-DMT, Clinical assessment is made by a reduction of at least 50% in the number of binge eating and purging episodes per week. The response was at least the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-31, which lasts for up to 21 days. This is the pharmaceutically acceptable salt. Compared to the number of binge eating and vomiting episodes per week prior to administration of 33.5-MeO-DMT, Clinical assessment is made by a reduction of at least 75% in the number of binge eating and purging episodes per week. The response occurred 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Existing 5-MeO-DMT or pharmaceutically acceptable 5-MeO-DMT for use as described in Embodiments 1 to 32 The salt is tolerable. 34. The patient has 21 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Symptoms of bulimia nervosa are determined by zero episodes of binge eating and vomiting per week. 5-MeO-DMT or drug for use according to Embodiments 1-33 in a state of remission That salt is scientifically acceptable. Compared to the number of binge eating and vomiting episodes per week prior to administration of 35.5-MeO-DMT, Clinical assessment is made by a reduction of at least 50% in the number of binge eating and purging episodes per week. The response was at least the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-34, which lasts for up to 28 days. This is the pharmaceutically acceptable salt. Compared to the number of binge eating and vomiting episodes per week prior to administration of 36.5-MeO-DMT, Clinical assessment is made by a reduction of at least 75% in the number of binge eating and purging episodes per week. The response occurred 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Existing 5-MeO-DMT or pharmaceutically acceptable 5-MeO-DMT for use as described in Embodiments 1 to 35 The salt is tolerable. 37. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Symptoms of bulimia nervosa are determined by zero episodes of binge eating and vomiting per week. 5-MeO-DMT or drug for use according to Embodiments 1-36 in a state of remission That salt is scientifically acceptable. For use as described in Embodiments 1 to 37, administered in 38.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 39. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 38 salt. 40. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 38-39, including administration of the salt This is the pharmaceutically acceptable salt. 41. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 38-40. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 42. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 38-41, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 43. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 38 or 42, including the Pharmacopoeia That salt is generally acceptable. 44,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 37 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 45,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-37 .

[0147] Embodiments relating to the treatment of bulimia nervosa 1. Diagnosed with bulimia nervosa by a qualified professional in accordance with accepted medical procedures. 5-methoxy-N,N-dimethyltryptamine (5-M) for use in patient treatment eO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has moderate or severe episodes of overeating, as indicated by four or more episodes per week. For use in individuals suffering from bulimia, 5-MeO-DMT or as described in Embodiment 1 or 2 That salt is pharmaceutically acceptable. 4. The patient suffers from a severe bulimia disorder characterized by eight or more episodes of binge eating per week. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 3 salt. 5. For use according to Embodiments 1-4, when the patient is diagnosed with treatment-resistant bulimia nervosa. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9. Administered in a dose or dosage regimen that induces the patient to experience a peak psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable so for use as described in Embodiments 1 to 8 Salt. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air through the thin layer, Aerosol particles are produced by creating aerosol particles for use as described in Embodiment 19. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Compared to the number of binge eating episodes per week before administration of 27.5-MeO-DMT, A clinical response, as determined by a reduction of at least 50% in the number of overeating episodes per interval, Occurs within approximately 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 26 That salt. 28. Remission of symptoms of bulimia nervosa, as determined by 0 binge eating episodes per week. Within approximately 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 27. The salt that is used. Compared to the number of binge eating episodes per week before administration of 29.5-MeO-DMT, A clinical response, as determined by a reduction of at least 50% in the number of overeating episodes per interval, At least 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically effective for use as described in Embodiments 1-28, which lasts until [time]. The salt that is permissible. Compared to the number of binge eating episodes per week before administration of 30.5-MeO-DMT, A clinical response, as determined by a reduction of at least 75% in the number of overeating episodes per interval, 5-MeO-DMT or a pharmaceutically acceptable salt thereof is present 7 days after the last dose. 5-MeO-DMT or pharmaceutically acceptable so for use as described in Embodiments 1 to 29 Salt. 31. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of symptoms of bulimia nervosa, as determined by 0 binge eating episodes per week. 5-MeO-DMT or pharmaceutically available for use as described in Embodiments 1-30 The salt is acceptable. Compared to the number of binge eating episodes per week before administration of 32.5-MeO-DMT, A clinical response, as determined by a reduction of at least 50% in the number of overeating episodes per interval, At least 21 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically effective for use as described in Embodiments 1-31, which lasts until The salt that is permissible. Compared to the number of binge eating episodes per week before administration of 33.5-MeO-DMT, A clinical response, as determined by a reduction of at least 75% in the number of overeating episodes per interval, It is present 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 32 That salt. 34. The patient has 21 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of symptoms of bulimia nervosa, as determined by 0 binge eating episodes per week. 5-MeO-DMT or pharmaceutically available for use as described in Embodiments 1-33 The salt is acceptable. Compared to the number of binge eating episodes per week before administration of 35.5-MeO-DMT, A clinical response, as determined by a reduction of at least 50% in the number of overeating episodes per interval, At least 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically effective for use as described in Embodiments 1-34, which lasts until The salt that is permissible. Compared to the number of binge eating episodes per week before administration of 36.5-MeO-DMT, A clinical response, as determined by a reduction of at least 75% in the number of overeating episodes per interval, It is present 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 35 That salt. 37. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of symptoms of bulimia nervosa, as determined by 0 binge eating episodes per week. 5-MeO-DMT or pharmaceutically available for use as described in Embodiments 1-36 The salt is acceptable. For use as described in Embodiments 1 to 37, administered in 38.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 39. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 38 salt. 40. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 38-39, including administration of the salt This is the pharmaceutically acceptable salt. 41. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 38-40. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 42. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 38-41, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 43. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 38 or 42, including the Pharmacopoeia That salt is generally acceptable. 44,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 37 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 45,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-37 .

[0148] Embodiments relating to the treatment of psychoactive substance abuse 1. Diagnosis of psychoactive substance abuse by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine for use in the treatment of patients ( 5-MeO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has at least four of the 11 DSM-5 diagnostic criteria for substance use disorder. The existence of criteria indicates that the person is suffering from moderate or severe psychoactive substance abuse. 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Form 1 or 2 salt. 4. The patient has met at least six of the 11 DSM-5 diagnostic criteria for substance use disorder. The existence of a discriminatory standard indicates that the person suffers from severe psychoactive substance abuse, as described in Embodiment 3. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 5. The use described in Embodiments 1-4 in which the patient is diagnosed with treatment-resistant psychoactive substance abuse. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. 11. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5 Embodiment 1: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~9. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-1 in which an equimolar amount of pharmaceutically acceptable salt is administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. The first dose of 14.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 19,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 18 salt. 20. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air through the thin layer, Aerosol particles are produced by creating aerosol particles for use as described in Embodiment 19. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. 5-Me for use in the form of a free base, as described in Embodiments 18-20. O-DMT. 22. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use as described in Embodiments 18-21, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 23. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 23, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 25. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-24, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 26. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-25, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Compared to the number of 27.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 50% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response occurs approximately 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-26, occurring within 20 days That salt is generally acceptable. 28. Of the 11 DSM-5 diagnostic criteria for substance use disorder, 0 exist. Remission of psychoactive substance abuse, as determined by 5-MeO-DMT or pharmacy The use described in Embodiments 1-27 occurs within approximately 14 days after the last dose of the salt that is permissible. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Compared to the number of 29.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 50% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response is observed with less than one dose of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-28, which lasts for up to 14 days. Or a pharmaceutically acceptable salt thereof. Compared to the number of 30.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 75% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response is observed 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically available for use as described in Embodiments 1-29 The salt is acceptable. 31. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], there were 0 of the 11 DSM-5 diagnostic criteria for substance use disorder. The states described in Embodiments 1 to 30 are in a state of remission from psychoactive substance abuse, as determined by the following: 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Compared to the number of 32.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 50% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response is observed with less than one dose of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-31, which lasts for up to 21 days. Or a pharmaceutically acceptable salt thereof. Compared to the number of 33.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 75% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response within 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically acceptable substances present in the eye for use as described in Embodiments 1-32 The salt that is permissible. 34. The patient has 21 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], there were 0 of the 11 DSM-5 diagnostic criteria for substance use disorder. The states described in Embodiments 1 to 33 are in a state of remission from psychoactive substance abuse, as determined by the following: 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Compared to the number of 35.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 50% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response is observed with less than one dose of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-34, which lasts for up to 28 days. Or a pharmaceutically acceptable salt thereof. Compared to the number of 36.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 75% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response within 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically acceptable substances present in the eye for use as described in Embodiments 1-35 The salt that is permissible. 37. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], there were 0 of the 11 DSM-5 diagnostic criteria for substance use disorder. The states described in Embodiments 1 to 36 are in a state of remission from psychoactive substance abuse, as determined by the following: 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. For use as described in Embodiments 1 to 37, administered in 38.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 39. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 38 salt. 40. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to Embodiments 38-39, including administration of the salt This is the pharmaceutically acceptable salt. 41. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 38-40. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 42. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 38-41, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 43. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 38 or 42, including the Pharmacopoeia That salt is generally acceptable. 44,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 37 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 45,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-37 .

[0149] Treatment of major depressive disorder with suicidal ideation or imminent risk of suicide Embodiments relating to placement 1. Diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practices. Furthermore, it is diagnosed by a qualified professional in accordance with accepted medical practices, with consent. For use in the treatment of patients who have suicidal ideation or are at imminent risk of suicide. 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or pharmaceutical The salt that is permissible. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a score of 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS). By, or by the Hamilton Depression Rating Scale (HAM-D) score of 17 or more items. Patients suffering from moderate or severe major depressive disorder, and with a clinically balanced overall impression of suicidal tendencies. Based on the Critical Severity-Revised (CGI-SS-R) scale, moderate suicidal tendency, marked suicidal tendency, severe Suicidal tendencies, or what is considered to be extreme suicidal tendencies, are the use of the method described in Embodiment 1 or 2. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 4. The patient is diagnosed with a MADRS score of 35 or higher, or a HAM-D score of 25 or higher. Patients suffering from severe major depressive disorder, and also with a revised clinical overall impression score - suicidal tendency severity score ( Based on the CGI-SS-R scale, marked suicidal tendency, severe suicidal tendency, or extreme suicidal inclination 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiment 3 is considered appropriate. The salt is tolerable. 5. When the patient is diagnosed with treatment-resistant major depressive disorder, the use described in Embodiments 1-4 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-5, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 7. A dose of approximately 4 mg to 20 mg of 5-MeO-DMT is administered, or 5-MeO-DMT In embodiments 1-6, an equimolar amount of a pharmaceutically acceptable salt is administered instead of O-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 8. A dose of approximately 6 mg, 12 mg, or 18 mg is administered, or 5- Embodiment 1 - In which equimolar amounts of a pharmaceutically acceptable salt are administered instead of MeO-DMT 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 6. 9,5-MeO-DMT or its salt is administered in the first dose for the first administration, and 5- MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Unless they experience a supreme psychedelic experience, use a higher dose than the previous one. 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiments 1 to 7 salt. 10,5-MeO-DMT is administered in a dose of approximately 2 mg to 8 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 8 mg. The dosage was increased to approximately 14 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 14 mg to 20 mg, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [reference]. The first dose of 11.5-MeO-DMT is approximately 6 mg, and the second dose of 5-MeO-DMT is approximately 6 mg. The dosage of the first drug is approximately 12 mg, and the third dosage of 5-MeO-DMT is approximately 18 mg. Alternatively, an equimolar amount of a pharmaceutically acceptable salt is administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 10. 12. The interval between 12.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. 5-MeO-DMT or pharmaceutically acceptable substance for use as described in application forms 9-11 salt. 13. The occurrence of a supreme psychedelic experience is related to the completion of the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 6-12, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 14. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 13 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 15. 5-Me for use as described in any of the preceding embodiments, administered by inhalation. O-DMT or a pharmaceutically acceptable salt thereof. 16,5-MeO-DMT or a pharmaceutically acceptable salt thereof is (a) pharmaceutically acceptable (b) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Or it is administered in the form of an aerosol containing pharmaceutically acceptable aerosol particles of its salt, Allosols have a mass density of aerosol particles ranging from approximately 0.5 mg / l to approximately 12.5 mg / l. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 15 salt. 17. Aerosol a) composed of 5-MeO-DMT or pharmaceutically a) Exposing the permissible thin layer of salt to thermal energy, and b) passing air through the thin layer, Aerosol particles are produced by creating aerosol particles for use as described in Embodiment 16. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5-Me for use in the form of a free base, as described in Embodiments 15-17. O-DMT. 19. The amount of 5-MeO-DMT or pharmaceutically acceptable salt administered to the patient is a single dose. 5-MeO-DMT for use described in embodiments 15-18, which is inhaled by breathing. This is the pharmaceutically acceptable salt. 20. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-19, occurring within 19 That salt is generally acceptable. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1-20, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 23. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1 to 22, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 24. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by a 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO-DMT for use as described in Embodiments 1-23 occurs within approximately 2 hours thereafter. Or a pharmaceutically acceptable salt thereof. A MADRS score of 25.10 or lower, or a HAM-D score of 7 or lower, and CGI-S This is determined by the score on the SR scale, which indicates either no suicidal tendencies or suspected suicidal tendencies. Remission of depressive symptoms and suicidal ideation with 5-MeO-DMT or pharmaceutically acceptable 5- for use as described in Embodiments 1-24, occurring within approximately 2 hours after the last dose of salt. MeO-DMT or a pharmaceutically acceptable salt thereof. 26. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by a 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO- for use according to Embodiments 1-25, which lasts for at least 6 days thereafter. DMT or a pharmaceutically acceptable salt thereof. 27. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by an improvement of at least 75% and a reduction of at least two levels on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO-DMT or for use as described in Embodiments 1-26, present on the 7th day after the first use. That salt is pharmaceutically acceptable. 28. If the patient has had 5-MeO-DMT or a pharmaceutically acceptable salt thereof for 7 days since the last dose In the eyes, a MADRS score of 10 or less or a HAM-D score of 7 or less, and CGI-S This is determined by the score on the SR scale, which indicates either no suicidal tendencies or suspected suicidal tendencies. 5 for use according to Embodiments 1-27, in a state of remission of depressive symptoms and suicidal ideation -MeO-DMT or a pharmaceutically acceptable salt thereof. 29. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by a 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO for use according to Embodiments 1-28, which lasts for at least 14 days after the use described above. - DMT or a pharmaceutically acceptable salt thereof. 30. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by an improvement of at least 75% and a reduction of at least two levels on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO-DMT for use described in Embodiments 1-29, which is present on the 14th day after the previous day. This is the pharmaceutically acceptable salt. 31. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day 1, a MADRS score of 10 or less or a HAM-D score of 7 or less, and CGI- The determination is made based on the SS-R scale, which indicates either no suicidal tendencies or suspected suicidal tendencies. For use in embodiments 1 to 30, in a state of remission of depressive symptoms and suicidal ideation 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 32. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by a 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO for use according to Embodiments 1-31, which lasts for at least 28 days after the use described above. - DMT or a pharmaceutically acceptable salt thereof. 33. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by an improvement of at least 75% and a reduction of at least two levels on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO-DMT for use described in Embodiments 1-32, which is present on day 28. This is the pharmaceutically acceptable salt. 34. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day 1, a MADRS score of 10 or less or a HAM-D score of 7 or less, and CGI- The determination is made based on the SS-R scale, which indicates either no suicidal tendencies or suspected suicidal tendencies. For use in embodiments 1 to 33, in a state of remission of depressive symptoms and suicidal ideation 5-MeO-DMT or a pharmaceutically acceptable salt thereof. For use as described in Embodiments 1 to 34, administered in 35.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 36. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 35 salt. 37. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-22 5-MeO-DMT for use according to embodiments 35-36, including administration of the salt This is the pharmaceutically acceptable salt. 38. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 35-37. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 39. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 35-38, which is between 24 hours and more. MT or its pharmaceutically acceptable salt. 40. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 35 or 39, including the Pharmacopoeia That salt is generally acceptable. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 34 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 42,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, and a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-34 . [Examples]

[0150] The following examples are listed to aid in understanding the present invention and the claims that follow. This does not limit the invention as described in the box in any way, and is not construed as limiting it. It shouldn't be done.

[0151] [Example 1] [Example 1A] Administration of 5-MeO-DMT by inhalation Volcano Medic Vaporization System Volcano Medic Vaporization System(Storz By using & Bickel (Germany) to volatilize the drug, 5-MeO-DM T aerosol was generated. The device is a hot air generator and the patient receives the aerosol from it. It consists of a detachable valve balloon for suction. The hot air generator is regulated between approximately 40°C and 210°C. The device can generate the desired temperature, and the airflow rate is approximately 12 liters per minute. The central part is a medication cap to which an appropriate dose of 5-MeO-DMT in ethanol solution is applied. The cell, and the capsule, is then applied to the device's filling chamber, where it is heated by hot air. It is heated. The medication capsule is tightly packed with stainless steel wire mesh (drip). It contains a small disc made from a pad (also called a liquid pad). The bott...

Claims

1. A composition for use in the treatment of a patient diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practice, comprising 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered by inhalation, nasal administration, buccal administration or sublingual administration.

2. The composition according to claim 1, wherein the disorder is diagnosed in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) published by the American Psychiatric Association, or the disorder is diagnosed in accordance with other diagnostic criteria accepted in medical practice.

3. The composition according to claim 1 or 2, wherein the patient suffers from moderate or severe major depressive disorder as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or more prior to treatment, or by a Hamilton Depression Rating Scale (HAM-D) score of 17 or more items prior to treatment.

4. The composition according to claim 3, wherein the patient suffers from severe major depressive disorder as indicated by a pre-treatment MADRS score of 35 or higher, or a pre-treatment HAM-D score of 25 or higher.

5. The composition according to any one of claims 1 to 4, wherein the patient is diagnosed with treatment-resistant major depressive disorder.

6. The composition according to any one of claims 1 to 5, wherein the patient further suffers from suicidal ideation.

7. The composition according to any one of claims 1 to 6, wherein 5-MeO-DMT or a salt thereof is administered to the patient in a dose or dosage regimen that causes the patient to experience a supreme psychedelic experience.

8. The composition according to any one of claims 1 to 7, wherein a dose of 4 mg to 20 mg of 5-MeO-DMT is administered, or an equimolar amount of a pharmaceutically acceptable salt is administered.

9. The composition according to any one of claims 1 to 8, wherein a dose of 6 mg, 8 mg, 10 mg, 12 mg, 14 mg, 16 mg, or 18 mg of 5-MeO-DMT is administered, or an equimolar amount of a pharmaceutically acceptable salt is administered.

10. The composition according to any one of claims 1 to 9, wherein a dose of 6 mg, 8 mg, 12 mg, or 18 mg of 5-MeO-DMT is administered, or an equimolar amount of a pharmaceutically acceptable salt is administered.

11. The composition according to any one of claims 1 to 10, wherein 5-MeO-DMT or a salt thereof is administered in a first dose in a first dose, and 5-MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses.

12. The composition according to claim 11, wherein each subsequent dose is administered in a higher dose than the previous dose.

13. The composition according to claim 11, wherein 5-MeO-DMT or a salt thereof is administered in a first dose, and 5-MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses unless the patient experiences a supreme psychedelic experience.

14. 5-MeO-DMT is administered in a dose of 2 mg to 8 mg for the first dose, and thereafter, Unless the patient has already experienced a supreme psychedelic experience, Unless the supervising physician has determined that further dose increases are inappropriate based on observed side effects, The second dose was increased to 8 mg to 14 mg, and thereafter, Unless the patient has already experienced a supreme psychedelic experience, Unless the supervising physician has determined that further dose increases are inappropriate based on observed side effects, The composition according to any one of claims 1 to 13, wherein the third dose is increased to 14 mg to 20 mg, or an equimolar amount of a pharmaceutically acceptable salt is administered.

15. The composition according to claim 14, wherein a first dose of 5-MeO-DMT is 6 mg, a second dose of 5-MeO-DMT is 12 mg, a third dose of 5-MeO-DMT is 18 mg, or an equimolar amount of a pharmaceutically acceptable salt is administered.

16. The composition according to any one of claims 12 to 15, wherein the interval between two administrations is 1 hour or more and 24 hours or less.

17. The composition according to claim 16, wherein the interval between two doses is 1 to 4 hours.

18. The composition according to claim 17, wherein the interval between two doses is one hour.

19. The composition according to any one of claims 7 to 18, wherein the occurrence of a supreme psychedelic experience is identified by achieving at least 60% of the highest possible score on each of the four subscales (mystical, positive mood, spacetime transcendence and inexpressibility) of the 30-item Revised Mystical Experiences Questionnaire (MEQ30), or by achieving at least 60% of the highest possible score on the Oceanic Feeling (OBN) aspect of the Altered States of Consciousness (ASC) Questionnaire, or by achieving a total score of at least 75 Supreme Psychedelic Experiences Questionnaires (PPEQ).

20. The composition according to any one of claims 1 to 19, wherein 5-MeO-DMT is used in the form of a free base.

21. The composition according to any one of claims 1 to 20, wherein a clinical response, as determined by a score of at least “marked improvement” on the Clinical Global Impression-Improvement (CGI-I) score or the Patient's Global Impression-Improvement (PGI-I) score, occurs within two hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

22. The composition according to any one of claims 1 to 21, wherein a clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, is observed on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

23. The composition according to any one of claims 1 to 22, wherein a clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, is observed 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

24. The composition according to any one of claims 1 to 23, wherein a clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, is observed 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

25. The composition according to any one of claims 1 to 24, wherein a clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective scores before treatment, occurs within two hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

26. The composition according to any one of claims 1 to 25, wherein remission of depressive symptoms, as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, occurs within two hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

27. ​​The composition according to any one of claims 1 to 26, wherein a clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective scores before treatment, is observed on the 7th day after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

28. The composition according to any one of claims 1 to 27, wherein a clinical response, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores before treatment, is present on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

29. The composition according to any one of claims 1 to 28, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, seven days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

30. The composition according to any one of claims 1 to 29, wherein a clinical response, as determined by at least a 50% improvement in the MADRS or HAM-D score compared to the respective scores before treatment, is observed 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

31. The composition according to any one of claims 1 to 30, wherein a clinical response, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores before treatment, is present 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

32. The composition according to any one of claims 1 to 31, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

33. The composition according to any one of claims 1 to 32, wherein a clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective scores before treatment, is observed 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

34. The composition according to any one of claims 1 to 33, wherein a clinical response, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores before treatment, is present 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

35. The composition according to any one of claims 1 to 34, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

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