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NCT Number: NCT06070649

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

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.

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Key information

Conditions

Alcohol Use Disorder (AUD) Alcohol Drinking Alcohol Use Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location status: Recruiting

Location contact

Anahita Bassir Nia, MD

CONTACT

[email protected]

Anahita Bassir Nia, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion

Drug

Infusion

Other names: Moderate Dose DMT

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

Drug

Infusion

Other names: Low Dose DMT

25 mg Diphenhydramine (5 min) + Normal Saline

Drug

Infusion

Primary outcomes

  1. Safety and tolerability of DMT in women and men with AUD

    Time frame: Day 0 through Day 56

    Systematic Assessment for Treatment Emergent Effects (SAFTEE) and MedDRA will be used weekly for 8 weeks to assess safety and tolerability of DMT in women and men with AUD.

  2. The effects of DMT, plus psychotherapy, on alcohol consumption

    Time frame: Day 0 through Day 56

    We will assess the desire of participants to drink alcohol in an experimental setting using the Alcohol Drinking Paradigm.

Secondary outcomes

  1. The relationship between acute psychedelic effects of DMT and alcohol consumption

    Time frame: Day 0 through Day 56

    The Mystical Experience Questionnaire (MEQ) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption.

  2. The relationship between acute psychedelic effects of DMT and alcohol consumption

    Time frame: Day 0 through Day 56

    The Ego-Dissolution Inventory (EDI) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption.

  3. 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 Timeline Followback (TLFB) approach will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption.

  4. 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

    Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption.

  5. 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

    Substance use disorder behaviors and risks with the Brief Addiction Monitor (BAM) will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption.

  6. The prosocial effects of DMT, plus psychotherapy, and changes in personality traits

    Time frame: Day 0 through Day 56

    Prosocial effects with be assessed using the Prosocial Personality Battery (PSP). The scale consists of 56 total items and uses a Likert-type scale with 5 answer-choices.

  7. The prosocial effects of DMT, plus psychotherapy, and changes in personality traits

    Time frame: Day 0 through Day 56

    Prosocial effects with be assessed using the Social Connectedness Scale - Revised (SCS-R).

  8. The prosocial effects of DMT, plus psychotherapy, and changes in personality traits

    Time frame: Day 0 through Day 56

    Prosocial effects with be assessed using the Mindful Attention Awareness Scale (MAAS).

  9. 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 Life Events Checklist (LEC) will be used to assess the relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma.

  10. 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 Childhood Trauma Questionnaire (CTQ-SF) will be used to assess the relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelina Contreras

CONTACT

[email protected]

(203) 974-7525

Ardavan Mohammad Aghaei

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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