Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans (DMT-Bolus)

This Phase I, randomised, placebo-controlled, triple-masked, crossover design trial (n=60) will investigate the safety, tolerability, electrophysiological effects, and efficacy of dimethyltryptamine (DMT) in individuals with major depressive disorder (MDD) and healthy controls. Participants will receive low and medium doses of DMT (10 mg bolus over five minutes followed by 0.01 mg/kg/min for 55 minutes; 14 mg bolus over five minutes followed by 0.015 mg/kg/min for 55 minutes) and tetrahydrocannabinol (THC) via intravenous administration.

Conducted by Yale University and led by Dr Deepak C. D’Souza, the study aims to assess DMT’s impact on depression, neuroplasticity, and mood using electroencephalographic (EEG) measures and psychometric assessments.

Participants will undergo two dosing sessions, separated by four weeks, to evaluate physiological and subjective effects. Safety will be monitored through vital signs, psychological assessments, and blood samples. The study is expected to begin in March 2025, with completion anticipated by December 2027.

Topic Depression Healthy Subjects Safety
Compound DMT Placebo
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 March 2025
End date 01 December 2027
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 60
Sex All
Age 21- 65
Therapy No

Trial Details

The goal of this phase 1 study is to investigate the safety and efficacy of dimethyltryptamine (DMT) in individuals with depression and healthy controls. We hypothesize that administration of DMT will result in decreases in depression, associated symptoms, and neuroplastic changes in depressed subjects. We expect that DMT will induce changes in neuroplasticity as indexed using electroencephalographic (EEG) measures and tasks in both depressed individuals and healthy volunteers, though to different degrees. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.

Trial Number NCT06671977

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

Data attribution

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