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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol-Related Disorders; Alcohol Use; Alcohol Use Disorder (AUD)
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Angelina Contreras; Phone Number: (203) 974-7525; Email: angelina.contreras@yale.edu
• Study Contact Backup: Name: Ardavan Mohammad Aghaei; Email: ardavan.mohammadaghaei@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Connecticut Mental Health Center
      • Principal Investigator: Anahita Bassir Nia, MD
      • Contact: Anahita Bassir Nia, MD; Email: anahita.bassirnia@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)	Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion; Infusion; Other Names: Moderate Dose DMT
Active Comparator: Group 2; Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)	Drug: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion; Infusion; Other Names: Low Dose DMT
Placebo Comparator: Group 3; Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)	Drug: 25 mg Diphenhydramine (5 min) + Normal Saline; Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of DMT in women and men with AUD	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.	Day 0 through Day 56
The effects of DMT, plus psychotherapy, on alcohol consumption	We will assess the desire of participants to drink alcohol in an experimental setting using the Alcohol Drinking Paradigm.	Day 0 through Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relationship between acute psychedelic effects of DMT and alcohol consumption	The Mystical Experience Questionnaire (MEQ) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption.	Day 0 through Day 56
The relationship between acute psychedelic effects of DMT and alcohol consumption	The Ego-Dissolution Inventory (EDI) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption.	Day 0 through Day 56
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.	The Timeline Followback (TLFB) approach will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption.	Day 0 through Day 56
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.	Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption.	Day 0 through Day 56
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.	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.	Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits	Prosocial effects with be assessed using the Prosocial Personality Battery (PSP). The scale consists of 56 total items and uses a Likert-type scale with 5 answer-choices.	Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits	Prosocial effects with be assessed using the Social Connectedness Scale - Revised (SCS-R).	Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits	Prosocial effects with be assessed using the Mindful Attention Awareness Scale (MAAS).	Day 0 through Day 56
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma	The Life Events Checklist (LEC) will be used to assess the relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma.	Day 0 through Day 56
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma	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.	Day 0 through Day 56

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Anahita Bassir Nia, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: October 1, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Behavior; Alcoholism; Alcohol Drinking; Alcohol-Related Disorders; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Indoles; Benzene Derivatives; Crystalloid Solutions; Isotonic Solutions; Solutions; Ethylamines; Biogenic Monoamines; Biogenic Amines; Tryptamines; Benzhydryl Compounds; Diphenhydramine; N,N-Dimethyltryptamine; Saline Solution
• Other Study ID Numbers: 2000035937; 1R21AA030649-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No