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NCT06070649PHASE1Recruiting

The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)

Yale University

Start Date

8/4/2025

Completion Date

8/1/2026

Summary

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.

Detailed Description

This study is a placebo-controlled, randomized, double blind, clinical trial to investigate the safety, tolerability and efficacy of the psychedelic dimethyltryptamine (DMT), in addition to a short course of psychotherapy, on Alcohol Use Disorder (AUD). The investigators hypothesize that relative to control (0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion plus psychotherapy), a single psychedelic dose of DMT (plus psychotherapy) in individuals with AUD will 1) be safe and 2) well-tolerated, and 3) reduce alcohol consumption measured in the laboratory the day after, and over the following 8 weeks.

Eligibility Criteria

Age Range: 21 years to 65 years

Inclusion Criteria: * Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder * Medically healthy * Ability to provide consent Exclusion Criteria: * Unstable medical conditions

Interventions

DRUG

0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion

DRUG

0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion

DRUG

25 mg Diphenhydramine (5 min) + Normal Saline

Interested in This Trial?

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Conditions

Alcohol Use Disorder (AUD)Alcohol-Related DisordersAlcohol Use

Locations

Connecticut Mental Health Center

New Haven, Connecticut 06519

United States