NCT06070649

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder (AUD)
• Alcohol-Related Disorders
• Alcohol Use

Interventions

Type	Name	Description
DRUG	0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion	Infusion
DRUG	0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion	Infusion
DRUG	25 mg Diphenhydramine (5 min) + Normal Saline	Infusion

Timeline

• Start date: 2025-08-04
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-10-06
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study