Safety and Tolerability of DMT in Healthy Adults

Universidade Federal do Rio Grande do Norte

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Safety Issues

Treatments: Drug: N,N-Dimethyltryptamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05901012

DMTcog

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

60mg of N,N-Dimethyltryptamine

Experimental group

Description:

One inhaled dose of 60mg of vaporized DMT.

Treatment:

Drug: N,N-Dimethyltryptamine

Placebo-like

Placebo Comparator group

Description:

One inhaled dose of 1mg of vaporized DMT.

Treatment:

Drug: Placebo