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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 through day 56

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability of DMT in women and men with AUD

The effects of DMT, plus psychotherapy, on alcohol consumption

Secondary outcome measures

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

801 Previous Clinical Trials

1,365,334 Total Patients Enrolled

423 Trials studying Alcoholism

985,645 Patients Enrolled for Alcoholism

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,150 Total Patients Enrolled

84 Trials studying Alcoholism

10,316 Patients Enrolled for Alcoholism

Anahita Bassir Nia, MDPrincipal InvestigatorYale University

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for this research trial limited to those above 18 years of age?

"This study has a minimum age requirement of 21 and an upper limit of 65, in line with the eligibility criteria."

Answered by AI

How deleterious are the consequences of exposure to Group 1 for individuals?

"Due to the limited data available on Group 1's safety and efficacy, our team at Power assigned it a score of 1 out of 3."

Answered by AI

Are there any particular demographics that would be more suitable for participation in this investigation?

"The study seeks to include 63 participants with an alcohol use disorder who are aged between 21 and 65."

Answered by AI

Are there any open sign-up slots for this trial at the moment?

"As noted on clinicaltrials.gov, this study is no longer seeking participants. Originally posted in October 1st of 2023 and last updated the same day, recruitment efforts have ended but there are still 387 other studies actively recruiting patients at present."

Answered by AI

What are the prime research aims of this investigation?

"This trial's primary outcome, to be observed over a 56-day period, is the influence of DMT and psychotherapy on alcohol consumption. Secondary outcomes include substance use disorder behaviours monitored by the Brief Addiction Monitor (BAM), mindfulness awareness evaluated with the Mindful Attention Awareness Scale (MAAS), and correlation between intensity of subjective psychedelic experience and childhood trauma determined through the Childhood Trauma Questionnaire (CTQ-SF)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Anahita Bassir Nia 2024. "The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06070649.

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