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

Phase 1

Not yet recruiting

• Conditions: Alcohol Use Disorder (AUD); Alcohol Use; Alcohol-Related Disorders
• Interventions: Drug: 25 mg Diphenhydramine (5 min) + Normal Saline; Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion; Drug: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion

• Registration Number: NCT06070649
• Lead Sponsor: Yale University

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-10-01
• Study First Posted: 2023-10-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-15
• Study Start: 2025-07-25
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	25 mg Diphenhydramine (5 min) + Normal Saline	Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)
Group 1	0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion	Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)
Group 2	0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion	Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of DMT in women and men with AUD	Day 0 through Day 56	Systematic Assessment for Treatment Emergent Effects (SAFTEE) and MedDRA will be used weekly for 8 weeks to assess safety and tolerability of DMT in women and men with AUD.
The effects of DMT, plus psychotherapy, on alcohol consumption	Day 0 through Day 56	We will assess the desire of participants to drink alcohol in an experimental setting using the Alcohol Drinking Paradigm.

Secondary Outcome Measures

Name	Time	Method
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits	Day 0 through Day 56	Prosocial effects with be assessed using the Mindful Attention Awareness Scale (MAAS).
The relationship between acute psychedelic effects of DMT and alcohol consumption	Day 0 through Day 56	The Ego-Dissolution Inventory (EDI) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption.
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.	Day 0 through Day 56	Substance use disorder behaviors and risks with the Brief Addiction Monitor (BAM) will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption.
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma	Day 0 through Day 56	The Childhood Trauma Questionnaire (CTQ-SF) will be used to assess the relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma.

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States