Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 21 to 65

Psychedelic DMT for Alcohol Use Disorder

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

Run by Yale University · NCT06070649 · Data updated 2026-11-12

This trial will test whether a single psychedelic dose of DMT plus a short course of psychotherapy helps people with Alcohol Use Disorder drink less.

Quick facts

PhasePhase 1
Study typeInterventional
Ages21 Years to 65 Years
SexAll
Enrollment63 (estimated)
SponsorYale University
Academic / other
Locations1 site (New Haven, Connecticut)
StatusRecruiting
StartedAugust 4, 2025
Main results expectedAugust 1, 2027
Study endsAugust 1, 2027
Registry record updatedSeptember 10, 2026
Trial IDNCT06070649 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are medically stable adults who meet DSM-5 criteria for Alcohol Use Disorder and can attend in-person sessions and provide informed consent.

Probably not a fit

People with unstable medical conditions or other contraindications to psychedelic treatment (for example certain cardiac or psychiatric problems) are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 1 trial gives a single infusion of DMT alongside a short course of psychotherapy to adults with Alcohol Use Disorder. Participants are randomized to receive one of several infusion regimens (including a 0.3 mg/kg/min DMT infusion, a lower-dose/control infusion, or diphenhydramine plus saline) under double-blind conditions. The primary goals are to measure safety and tolerability and to see if a single DMT session reduces alcohol consumption in a laboratory drinking session the next day and over an 8-week follow-up. All participants must be medically stable, meet DSM-5 criteria for AUD, and attend in-person visits at the Connecticut Mental Health Center.

Why it matters

Potential benefit: If successful, this approach could offer a new, fast-acting option to reduce drinking in people with Alcohol Use Disorder.

How similar studies have gone: Other psychedelic-assisted therapies, particularly psilocybin for substance use disorders, have shown promising early results, but single-dose DMT for AUD is relatively novel and less well-studied.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Connecticut Mental Health Center
    New Haven, Connecticut, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.