Clinical TrialAlcohol Use Disorder (AUD)DMTDMTPlaceboRecruiting

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

This double-blind, randomized, placebo-controlled, parallel-group laboratory trial (n=63) conducted by Yale University aims to determine the effects of DMT (14-21mg/70kg/min) infusions, in conjunction with psychotherapy, on Alcohol Use Disorder (AUD).

Target Enrollment
63 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Randomized, double-blind, placebo-controlled parallel-group laboratory study evaluating single-session intravenous DMT infusions plus a short course of psychotherapy in individuals with Alcohol Use Disorder.

Three arms compare a high-rate DMT bolus (0.3 mg/kg/min, 5 min) with a low-rate bolus plus maintenance (0.2 mg/kg/min bolus then 0.01 mg/kg/min maintenance) and an active placebo (25 mg diphenhydramine bolus); outcomes include safety, tolerability, and laboratory-measured alcohol consumption up to 8 weeks.

Psychotherapy is provided alongside dosing; primary aims are safety, tolerability, and reduction in alcohol consumption compared with active placebo.

Study Protocol

Preparation

sessions

Dosing

1 sessions
65 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

High DMT

experimental

Bolus 0.3 mg/kg/min (5 min) + saline infusion 60 min

Interventions

  • DMT0.3 mg/kg/min
    via IV• single dose• 1 doses total

    Bolus 0.3 mg/kg/min for 5 min; saline infusion 60 min.

Low DMT

experimental

Bolus 0.2 mg/kg/min (5 min) then maintenance 0.01 mg/kg/min (60 min)

Interventions

  • DMT0.2 mg/kg/min
    via IV• single dose• 1 doses total

    Bolus 0.2 mg/kg/min for 5 min then maintenance infusion 0.01 mg/kg/min for 60 min.

Diphenhydramine

active

25 mg diphenhydramine bolus (5 min) + saline infusion (60 min) — active placebo

Interventions

  • Placebo25 mg
    via IV• single dose• 1 doses total

    25 mg bolus (5 min) + saline infusion 60 min; used as active placebo (diphenhydramine).

Participants

Ages
21 – 65
Sexes
Male & Female

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 Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment63 participants
  • Timeline
    Start: 2024-03-17
    End: 2025-09-30
  • Compounds
    DMTDMTPlacebo
  • Topic
    Alcohol Use Disorder (AUD)

Locations

Connecticut Mental Health Center — New Haven, Connecticut, United States

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