Menu
Recruiting NCT06070649

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

Phase I Interventional Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcohol Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder (AUD), Alcohol-Related Disorders, Alcohol Use. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

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

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • The relationship between acute psychedelic effects of DMT and alcohol consumption [Time frame: Day 0 through Day 56]
  • The relationship between acute psychedelic effects of DMT and alcohol consumption [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Day 0 through Day 56]
  • The prosocial effects of DMT, plus psychotherapy, and changes in personality traits [Time frame: Day 0 through Day 56]
  • The prosocial effects of DMT, plus psychotherapy, and changes in personality traits [Time frame: Day 0 through Day 56]
  • The prosocial effects of DMT, plus psychotherapy, and changes in personality traits [Time frame: Day 0 through Day 56]
  • The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma [Time frame: Day 0 through Day 56]
  • The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma [Time frame: Day 0 through Day 56]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Connecticut Mental Health Center — New Haven

Identifiers

NCT: NCT06070649 · 2000035937 · 1R21AA030649-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗