Recruiting

Phase 1

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

Sponsor:

Yale University

Code:

NCT06070649

Conditions

Alcohol Use Disorder (AUD)

Alcohol-Related Disorders

Alcohol Use

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion

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

25 mg Diphenhydramine (5 min) + Normal Saline

Study Details

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.

Conditions

Alcohol Use Disorder (AUD)

Alcohol-Related Disorders

Alcohol Use

Study ID

NCT06070649

Start date

Aug 4, 2025

Status verified date

Aug, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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

Enrollment

63 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Group 1

Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)

active comparator: Group 2

Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)

placebo comparator: Group 3

Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)

Interventions

0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion

Infusion

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

Infusion

25 mg Diphenhydramine (5 min) + Normal Saline

Infusion

Primary outcome measure

Safety and tolerability of DMT in women and men with AUD [ Time Frame: Day 0 through Day 56 ]
The effects of DMT, plus psychotherapy, on alcohol consumption [ Time Frame: Day 0 through Day 56 ]

Central Contacts and Locations

Central contacts

Angelina Contreras

(203) 974-7525 angelina.contreras@yale.edu

Ardavan Mohammad Aghaei

ardavan.mohammadaghaei@yale.edu

Locations

Connecticut Mental Health Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Anahita Bassir Nia, MD

anahita.bassirnia@yale.edu

Principal Investigator:

Anahita Bassir Nia, MD

More Information

Sponsor

Yale University

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-18.