The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
- Conditions
- Alcohol Use Disorder (AUD)Alcohol UseAlcohol-Related Disorders
- Interventions
- Registration Number
- NCT06070649
- Lead Sponsor
- Yale University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 63
- Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder
- Medically healthy
- Ability to provide consent
- Unstable medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 25 mg Diphenhydramine (5 min) + Normal Saline Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min) Group 1 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min) Group 2 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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 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.
Trial Locations
- Locations (1)
Connecticut Mental Health Center
🇺🇸New Haven, Connecticut, United States