Safety and Tolerability of DMT in Healthy Adults

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

Detailed Description
-----------------
This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled) and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours; the substance order will be randomized.

Official Title
-----------------
Inhaled N,N-Dimethyltryptamine: a Safety and Tolerability Study in Healthy Adults

Conditions
-----------------
Safety Issues, Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: N,N-Dimethyltryptamine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous experience with DMT be right-handed healthy volunteers Exclusion Criteria: heart failure liver failure kidney failure uncontrolled high blood pressure history of heart rhythm disorders history of valvular heart disease history of chronic obstructive pulmonary disease (COPD) active or in treatment for bronchial asthma severe obesity coagulation disorders clinical evidence or history of increased intracranial clinical evidence or history of cerebrospinal pressure history or reports of epilepsy severe neurological disease, pregnancy reported or clinically recognized thyroid disorders diagnosis or family suspicion of genetic monoamine deficiency oxidase previous adverse response to psychedelic substances symptoms or family members with a present or past psychotic disorder dissociative identity disorder bipolar affective disorder prodromal symptoms of schizophrenia problematic use or abuse of alcohol or other psychoactive substances (except tobacco) acute or subacute risk of suicide acute flu symptoms symptoms of airway infection contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled) and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours, the substance order will be randomized.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60mg of N,N-Dimethyltryptamine<br>One inhaled dose of 60mg of vaporized DMT. | Drug: N,N-Dimethyltryptamine<br>* DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.<br>* Other names: DMT;|
| Placebo Comparator: Placebo-like<br>One inhaled dose of 1mg of vaporized DMT. | Drug: Placebo<br>* DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | Assessed 7 times on each session | up to 2 hours | 
| Diastolic Blood Pressure | Assessed 7 times on each session | up to 2 hours | 
| Heart rate | Assessed 7 times on each session | up to 2 hours | 
| Respiratory rate | Assessed 7 times on each session | up to 2 hours | 
| Oxygen saturation | Assessed 7 times on each session | up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma level of glucose | Assessed 2 times on each session | up to 2 hours | 
| Plasma level of total cholesterol | Assessed 2 times on each session | up to 2 hours | 
| Plasma level of C-reactive protein (CRP) | Assessed 2 times on each session | up to 2 hours | 
| Plasma level of urea | Assessed 2 times on each session | up to 2 hours | 
| Plasma level of creatinine | Assessed 2 times on each session | up to 2 hours | 
| Plasma level of aspartate transaminase (AST) | Assessed 2 times on each session | up to 2 hours | 
| Plasma level of alanine transaminase (ALT) | Assessed 2 times on each session | up to 2 hours | 
| Plasma level of cortisol | Assessed 2 times on each session | up to 2 hours | 
| Plasma level of subjective effects of DMT | Assessed 2 times on each session | up to 2 hours | 
| Evaluate the subjective effects of DMT | Assessment of the acute subjective effects of DMT, compared to placebo, by 5D-ASC (5 Dimensions- Altered States of consciousness). Scores range from 0 to 94, where higher scores indicate more intense psychedelic subjective effects. | up to 2 hours | 
| Evaluate the subjective effects of DMT | Assessment of the acute subjective effects of DMT, compared to placebo, by HRS (Hallucinogen Rating Scale). Scores range from 0 to 400, where higher scores indicate more intense psychedelic subjective effects. | up to 2 hours | 
| Evaluate the subjective effects of DMT | Assessment of the acute subjective effects of DMT, compared to placebo, by MEQ (Questionnaire of Mystical Experiences). Scores range from 0 to 150, where higher scores indicate more intense psychedelic subjective effects. | up to 2 hours | 
| Evaluate acute effects on alpha waves using electroencephalography before, during and after the dosing | Assessment of the electrical cerebral activity in different bandwidth as alpha waves by EEG before, during and after each session. | up to 1 hours | 
| Evaluate acute effects on beta waves using electroencephalography before, during and after the dosing | Assessment of the electrical cerebral activity in different bandwidth as beta waves by EEG before, during and after each session. | up to 1 hours | 
| Evaluate acute effects on theta waves using electroencephalography before, during and after the dosing | Assessment of the electrical cerebral activity in different bandwidth as theta waves by EEG before, during and after each session. | up to 1 hours | 
| Evaluate the subacute effects of DMT, compared to placebo, on electroencephalography markers | Assessment of the subacute effects of DMT on EEG, including ERP (event-related potential ) generated from visual and auditory stimulation by applying a visual and auditory perception and imagination task. | up to 0.5 hours | 
| Evaluate the acute effects of DMT, compared to placebo, on electroencephalography markers | Assessment of the acute effects of DMT in ERP (event-related potential) generated from auditory stimulation in an oddball protocol. | up to 0.5 hours | 
| Evaluate the subacute effects of DMT on suggestibility | Assessment of the subacute effects of DMT on suggestibility by applying a suggestibility task named Creative Imagination Scale (CIS). Scores range from 0 to 40. Higher scores indicate more intense suggestibility. | up to 1 hours | 
| Evaluate the influence of expectations | Assessment of the influence of expectations variables on subjective experience | up to 0.5 hours | 
| Evaluate the influence of personality trait | Assessment of the influence of personality trait on suggestibility | up to 0.5 hours | 
| Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography | Evaluate changes in serum DMT concentration over time measured in baseline, 2 and 50 minutes after each session. | up to 50 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
N,N-DMT, N,N-Dimethyltryptamine, DMT, placebo, psychedelic