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

Sponsor

Yale University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06070649

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcohol Use	Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion Drug: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion Drug: 25 mg Diphenhydramine (5 min) + Normal Saline	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)	Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion Infusion Other Names: Moderate Dose DMT
Active Comparator: Group 2 Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)	Drug: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion Infusion Other Names: Low Dose DMT
Placebo Comparator: Group 3 Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)	Drug: 25 mg Diphenhydramine (5 min) + Normal Saline Infusion

Arm

Intervention/Treatment

Active Comparator: Group 1

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

Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion

Infusion

Other Names:

Moderate Dose DMT

Active Comparator: Group 2

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

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

Infusion

Other Names:

Low Dose DMT

Placebo Comparator: Group 3

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

Drug: 25 mg Diphenhydramine (5 min) + Normal Saline

Infusion

Outcome Measures

Primary Outcome Measures

Safety and tolerability of DMT in women and men with AUD [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.
The effects of DMT, plus psychotherapy, on alcohol consumption [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 Outcome Measures

The relationship between acute psychedelic effects of DMT and alcohol consumption [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.
The relationship between acute psychedelic effects of DMT and alcohol consumption [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.
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks. [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.
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks. [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.
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks. [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.
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits [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.
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits [Day 0 through Day 56]
Prosocial effects with be assessed using the Social Connectedness Scale - Revised (SCS-R).
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits [Day 0 through Day 56]
Prosocial effects with be assessed using the Mindful Attention Awareness Scale (MAAS).
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma [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.
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder
Medically healthy
Ability to provide consent