This double-blind, randomized, placebo-controlled, parallel-group laboratory trial (n=63) conducted by Yale University aims to determine the effects of DMT (14-21mg/70kg/min) infusions, in conjunction with psychotherapy, on Alcohol Use Disorder (AUD).
Randomized, double-blind, placebo-controlled parallel-group laboratory study evaluating single-session intravenous DMT infusions plus a short course of psychotherapy in individuals with Alcohol Use Disorder.
Three arms compare a high-rate DMT bolus (0.3 mg/kg/min, 5 min) with a low-rate bolus plus maintenance (0.2 mg/kg/min bolus then 0.01 mg/kg/min maintenance) and an active placebo (25 mg diphenhydramine bolus); outcomes include safety, tolerability, and laboratory-measured alcohol consumption up to 8 weeks.
Psychotherapy is provided alongside dosing; primary aims are safety, tolerability, and reduction in alcohol consumption compared with active placebo.
Bolus 0.3 mg/kg/min (5 min) + saline infusion 60 min
Bolus 0.3 mg/kg/min for 5 min; saline infusion 60 min.
Bolus 0.2 mg/kg/min (5 min) then maintenance 0.01 mg/kg/min (60 min)
Bolus 0.2 mg/kg/min for 5 min then maintenance infusion 0.01 mg/kg/min for 60 min.
25 mg diphenhydramine bolus (5 min) + saline infusion (60 min) — active placebo
25 mg bolus (5 min) + saline infusion 60 min; used as active placebo (diphenhydramine).