Safety and Tolerability of DMT in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2023-07-17

Brief Summary

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

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Detailed Description

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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.

Conditions

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Safety Issues Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This study employs a double-blind design. The participant and investigator will all be blind to the order of substance administration during the dosing sessions. Each participant will undergo two dosing sessions on the same day, one with N,N-Dimethyltryptamine (DMT) at a dosage of 60 mg, and another with a placebo containing 1 mg of DMT. The order of substance administration (DMT or placebo) will be randomized and unknown to all parties involved in the study until data collection is complete to ensure unbiased results

Study Groups

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60mg of N,N-Dimethyltryptamine

One inhaled dose of 60mg of vaporized DMT.

Group Type EXPERIMENTAL

N,N-Dimethyltryptamine

Intervention Type DRUG

DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.

Placebo-like

One inhaled dose of 1mg of vaporized DMT.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.

Interventions

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N,N-Dimethyltryptamine

DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.

Intervention Type DRUG

Placebo

DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.

Intervention Type DRUG

Other Intervention Names

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DMT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes