Clinical Study of DMT in Healthy Adults

Study Overview
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Brief Summary
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This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine in healthy individuals.

Detailed Description
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Participants will receive N, N-Dimethyltryptamine administered in two dosing sessions: an initial low-dose safety session and subsequent intermediate-dose treatment, in a fixed order and 2h apart.

Official Title
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Inhaled N, N-Dimethyltryptamine: a Phase I Study in Healthy Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: N,N-Dimethyltryptamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prior experience with N,N-Dimethyltryptamine (DMT) present proof of vaccination against COVID-19 (Coronavírus) Exclusion Criteria: heart failure liver failure kidney failure resistant hypertension arrhythmia valvular heart disease chronic obstructive pulmonary disease asthma severe obesity epilepsy pregnancy thyroid disorders family diagnosis or suspicion of genetic monoamine oxidase deficiency previous adverse response to psychedelic substances present or past symptoms or family members with a psychotic disorder dissociative identity disorder bipolar disorder prodromal symptoms of schizophrenia abuse of alcohol or other psychoactive substances, except tobacco acute or sub-acute risk of suicide flu-like symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - single ascending dose<br>Administration of up to 2 inhaled doses of DMT within a single day (5 mg, followed by 20 mg) with a 2-hour dose interval (5 subjects). | Drug: N,N-Dimethyltryptamine<br>* DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen<br>* Other names: BMND01;|
| Experimental: Group B - single ascending dose<br>Administration of up to 2 inhaled doses of DMT within a single day (7.5 mg, followed by 30 mg) with a 2-hour dose interval (5 subjects). | Drug: N,N-Dimethyltryptamine<br>* DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen<br>* Other names: BMND01;|
| Experimental: Group C - single ascending dose<br>Administration of up to 2 inhaled doses of DMT within a single day (10 mg, followed by 40 mg) with a 2-hour dose interval (5 subjects). | Drug: N,N-Dimethyltryptamine<br>* DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen<br>* Other names: BMND01;|
| Experimental: Group D - single ascending dose<br>Administration of up to 2 inhaled doses of DMT within a single day (12.5 mg, followed by 50 mg) with a 2-hour dose interval (5 subjects). | Drug: N,N-Dimethyltryptamine<br>* DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen<br>* Other names: BMND01;|
| Experimental: Group E - single ascending dose<br>Administration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 2-hour dose interval (5 subjects). | Drug: N,N-Dimethyltryptamine<br>* DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen<br>* Other names: BMND01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation | Evaluate clinical and psychiatry acute risks after DMT treatments assessed by qualitative medical evaluation after dosing. | up to 1 month after dosing | 
| Blood Pressure | Assessed 20 times on each dose via systolic and diastolic blood pressure | up to 2 hours after each dose | 
| Heart rate | Assessed 20 times on each dose | up to 2 hours after each dose | 
| Respiratory rate | Assessed 20 times on each dose | up to 2 hours after each dose | 
| Oxygen saturation | Assessed 20 times on each dose | up to 2 hours after each dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma level of glucose | Assessed 2 times on each dose | up to 2 hours after each dose | 
| Plasma level of total cholesterol | Assessed 2 times on each dose | up to 2 hours after each dose | 
| Plasma level of C-reactive protein (CRP) | Assessed 2 times on each dose | up to 2 hours after each dose | 
| Plasma level of urea | Assessed 2 times on each dose | up to 2 hours after each dose | 
| Plasma level of creatinine | Assessed 2 times on each dose | up to 2 hours after each dose | 
| Plasma level of aspartate transaminase (AST) | Assessed 2 times on each dose | up to 2 hours after each dose | 
| Plasma level of alanine transaminase (ALT) | Assessed 2 times on each dose | up to 2 hours after each dose | 
| Plasma level of cortisol | Assessed 2 times on each dose | up to 2 hours after each dose | 
| Evaluate the subjective effects of DMT | Assessment of the acute subjective effects of DMT by Hallucinogen Rating Scale (HRS) after each dosing. Higher scores indicate more intense psychedelic subjective effects. | up to 2 hours after each dose | 
| Evaluate acute effects on cerebral activity using electroencephalography before, during and after the dosing | Assessment of the electrical cerebral activity in different bandwidth as alpha, beta, theta waves by EEG before, during and after each dosing. | up to 2 hours after each dose | 
| Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography | Evaluate changes in serum DMT concentration over time measured in 2, 5, 10, 15 and 120 minutes after each dosing. | up to 2 hours after each dose | 
| Evaluate the impact of after DMT on satisfaction with life using scale | Assessment of satisfaction with life in different time points as baseline, 1, 2, 7, 14 and 28 days after dosing using the Satisfaction with Life Scale (SWL). Scores ranging from 5 to 35. Higher scores indicate greater satisfaction with life. | up to 1 month after dosing | 
| Evaluate the impact of DMT on trait and state of anxiety using scale | Assessment of trait and state anxiety in different time points as baseline, 1, 2, 7, 14 and 28 days after dosing using the State-Trait Anxiety Inventory (STAI). Scores ranging from 0 to 63. Higher scores indicate more severe anxiety. | up to 1 month after dosing | 
| Evaluate the impact of DMT on quality of life using scale | Assessment of quality of life in different time points as baseline, 14 and 28 days after dosing using the questionnaires World Health Organization Quality of Life Assessment Instrument (WHOQOL-BREF). Scores ranging from 0 to 100. Higher scores indicate better quality of life. | up to 1 month after dosing | 
| Evaluate the impact of DMT on spirituality, religiousness and personal beliefs | Assessment of spirituality, religiousness and personal beliefs in different time points as baseline, 14 and 28 days after dosing using the World Health Organization Quality of Life Assessment Instrument for Spirituality, Religiousness and Personal Beliefs (WHOQOL-SRPB). The scale is divided in 8 domains, scores ranging from 4 to 20 in each domain. Higher levels indicate higher level of spirituality, religiousness and personal beliefs. | up to 1 month after dosing | 
| Evaluate the impact of DMT on affect using scale | Assessment of affect in different time points as baseline, 1, 2, 7, 14 and 28 days after dosing using the questionnaire Positive and Negative Affect Schedule (PANAS). To score the positive affect items 1, 3, 5, 9, 10, 12, 14, 16, 17 and 19 are summed up. Scores ranging from 10 to 50. Higher scores indicate higher levels of positive affect. To score the negative affect items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20 are summed up. Scores ranging from 10 to 50. Higher scores indicate higher levels of negative affect | up to 1 month after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, N,N-DMT, DMT, N,N-Dimethyltryptamine