Safety and Tolerability of DMT in Healthy Adults

This phase I, double-blind, randomized, placebo-controlled crossover trial (n=25) explores the acute and subacute effects of inhaled N,N-Dimethyltryptamine (DMT) in healthy adults.

Commencing on April 26, 2023, and concluding on July 17, 2023, the study involves two dosing sessions on the same day, administering either DMT (60 mg, inhaled) or a placebo (1 mg DMT, inhaled) to each participant. The sessions, lasting approximately two hours, will randomize the order of substance administration.

The trial primarily focuses on assessing safety and tolerability, measuring various physiological parameters such as blood pressure, heart rate, and respiratory rate, along with exploring the subjective effects of DMT using questionnaires and EEG measurements. The study is conducted at Hospital Universitário Onofre Lopes in Natal, RN, Brazil, with Draulio B. Araujo as the principal investigator.

Topic Healthy Subjects
Compound Placebo DMT
Country Brazil
Visit trial
Status Completed
Results Published No
Start date 26 April 2023
End date 17 July 2023
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 25
Sex All
Age 18- 60
Therapy No

Trial Details

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.

NCT Number NCT05901012

Sponsors & Collaborators

Universidade Federal do Rio Grande do Norte
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Data attribution

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