Clinical trial NCT06070649: The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
Official title: The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Alcohol Use Disorder (AUD)
Alcohol-Related Disorders
Alcohol Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-10-06
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability of DMT in women and men with AUD
timeFrame: Day 0 through Day 56
measure: The effects of DMT, plus psychotherapy, on alcohol consumption
timeFrame: Day 0 through Day 56
Secondary outcomes:
measure: The relationship between acute psychedelic effects of DMT and alcohol consumption
timeFrame: Day 0 through Day 56
measure: The relationship between acute psychedelic effects of DMT and alcohol consumption
timeFrame: Day 0 through Day 56
measure: The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
timeFrame: Day 0 through Day 56
measure: The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
timeFrame: Day 0 through Day 56
measure: The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
timeFrame: Day 0 through Day 56
measure: The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
timeFrame: Day 0 through Day 56
measure: The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
timeFrame: Day 0 through Day 56
measure: The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
timeFrame: Day 0 through Day 56
measure: The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma
timeFrame: Day 0 through Day 56
measure: The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma
timeFrame: Day 0 through Day 56
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Anahita Bassir Nia, MD
role: PRINCIPAL_INVESTIGATOR
References: