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

NCT06070649 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-04-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Anahita Bassir Nia, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2026-08-01
Completion
2026-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06070649 on ClinicalTrials.gov