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

NCT ID: NCT06070649

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-04

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcohol Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)

Group Type ACTIVE_COMPARATOR

0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion

Intervention Type DRUG

Infusion

Group 2

Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)

Group Type ACTIVE_COMPARATOR

0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion

Intervention Type DRUG

Infusion

Group 3

Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)

Group Type PLACEBO_COMPARATOR

25 mg Diphenhydramine (5 min) + Normal Saline

Intervention Type DRUG

Infusion

Interventions

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0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion

Infusion

Intervention Type DRUG

0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion

Infusion

Intervention Type DRUG

25 mg Diphenhydramine (5 min) + Normal Saline

Infusion

Intervention Type DRUG

Other Intervention Names

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Moderate Dose DMT Low Dose DMT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Anahita Bassir Nia

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anahita Bassir Nia, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angelina Contreras

Role: CONTACT

Phone: (203) 974-7525

Email: [email protected]

Ardavan Mohammad Aghaei

Role: CONTACT

Email: [email protected]

Facility Contacts

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Anahita Bassir Nia, MD

Role: primary

Other Identifiers

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2000035937

Identifier Type: -

Identifier Source: org_study_id

1R21AA030649-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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