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.
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.Trial Number NCT05901012
Sponsors & Collaborators
Universidade Federal do Rio Grande do NorteThis company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Safety, tolerability and subjective effects of vaporized N,N-Dimethyltryptamine: A randomized double-blind clinical trialThis first RCT (n=25) of vaporised DMT (60mg) demonstrated that DMT significantly increased subjective experience measures while causing only transient, safe physiological changes and predominantly mild adverse events. This suggests that inhaled DMT is safe, well-tolerated, and effective at inducing profound altered states of consciousness. Significant correlations were observed between physiological responses and subjective experiences.