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.
Details
Phase I randomised, triple-masked crossover in 60 participants (MDD and healthy controls) with two dosing sessions separated by 4 weeks to compare low and medium IV DMT, low and medium IV THC, and placebo.
Primary aims are safety, tolerability and electrophysiological/neuroplastic effects measured with EEG and task-based measures; clinical measures include depressive symptom scales (HAMD) and other psychometrics.
Dosing involves IV bolus over 5 minutes followed by ~55-minute infusion (DMT: 10 mg + 0.01 mg/kg/min or 14 mg + 0.015 mg/kg/min). Subjects receive preparation and debriefing around each session.