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

Yale University

Status and phase: Begins enrollment this month; Phase 1

Conditions: Alcohol Use; Alcohol Use Disorder (AUD); Alcohol-Related Disorders

Treatments: Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion; Drug: 25 mg Diphenhydramine (5 min) + Normal Saline; Drug: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06070649

1R21AA030649-01A1 (U.S. NIH Grant/Contract)

2000035937

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No 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

Exclusion criteria

• Unstable medical conditions

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

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

Treatment:

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

Group 2

Active Comparator group

Description:

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

Treatment:

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

Group 3

Placebo Comparator group

Description:

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

Treatment:

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