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).
The study hypothesizes that compared to the control group receiving a specific infusion plus psychotherapy, a single dose of DMT (plus psychotherapy) in individuals with AUD will be safe, well-tolerated, and will reduce alcohol consumption measured in the laboratory the day after and over the following 8 weeks.
Eligible participants, aged 21-65, must have a DSM-5 diagnosis of AUD and be medically healthy, capable of providing consent. Exclusion criteria include unstable medical conditions.
The trial will involve three groups: Group 1 receiving a bolus of 0.3mg/kg/min DMT infusion, Group 2 receiving a bolus of 0.2 mg/kg/min DMT infusion, and Group 3 receiving a placebo infusion. These infusions will be administered over specific timeframes.
Primary outcome measures include the safety and tolerability of DMT and its effects on alcohol consumption, while secondary outcomes include assessing the relationship between DMT effects and alcohol consumption, changes in personality traits, and the intensity of subjective psychedelic experience.
The study is expected to start on March 17, 2024, with an estimated completion date of September 30, 2025, and will be conducted at Connecticut Mental Health Center, New Haven, Connecticut, USA.
Trial Details
This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.NCT Number NCT06070649
Sponsors & Collaborators
Yale UniversityThe Yale Psychedelic Science Group was established in 2016.