Safety and Tolerability of DMT in Healthy Adults

Universidade Federal do Rio Grande do Norte25 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Safety Issues Healthy Volunteers

Interventions

N,N-DimethyltryptamineDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, Brazil

Outcomes

Primary Outcomes

Systolic Blood Pressure

Assessed 7 times on each session

Time frame: up to 2 hours

Diastolic Blood Pressure

Assessed 7 times on each session

Time frame: up to 2 hours

Heart rate

Assessed 7 times on each session

Time frame: up to 2 hours

Respiratory rate

Assessed 7 times on each session

Time frame: up to 2 hours

Oxygen saturation

Assessed 7 times on each session

Time frame: up to 2 hours