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Psychedelic

DMT + Psychotherapy for Alcoholism

Phase 1
Waitlist Available
Led By Anahita Bassir Nia, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 through day 56

Summary

This trial will look at the effects of DMT plus psychotherapy on Alcohol Use Disorder.

Who is the study for?
This trial is for medically healthy adults who have been diagnosed with Alcohol Use Disorder according to the DSM-5. Participants must be able to give informed consent. People with unstable medical conditions cannot join.
What is being tested?
The study tests the effects of DMT on Alcohol Use Disorder when combined with psychotherapy. It's a double-blind study, meaning neither participants nor researchers know who gets the real treatment or placebo. Some get DMT infusions; others get Diphenhydramine (an antihistamine) and saline as controls.
What are the potential side effects?
DMT can cause rapid heart rate, increased blood pressure, dizziness, dilated pupils, agitation, and hallucinations during infusion. Long-term side effects are not well understood due to limited research.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 through day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 through day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of DMT in women and men with AUD
The effects of DMT, plus psychotherapy, on alcohol consumption
Secondary study objectives
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
The relationship between acute psychedelic effects of DMT and alcohol consumption
+1 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Group 1Active Control1 Intervention
Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)
Group II: Group 2Active Control1 Intervention
Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)
Group III: Group 3Placebo Group1 Intervention
Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,707 Total Patients Enrolled
456 Trials studying Alcoholism
823,723 Patients Enrolled for Alcoholism
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,619 Total Patients Enrolled
91 Trials studying Alcoholism
10,914 Patients Enrolled for Alcoholism
Anahita Bassir Nia, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
45 Total Patients Enrolled
~42 spots leftby Sep 2025
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