The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
概览
- 阶段
- 1 期
- 干预措施
- 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion
- 疾病 / 适应症
- Alcohol Use Disorder (AUD)
- 发起方
- Yale University
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Safety and tolerability of DMT in women and men with AUD
- 状态
- 招募中
- 最后更新
- 4天前
概览
简要总结
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.
详细描述
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.
研究者
Anahita Bassir Nia
Assistant Professor of Psychiatry
Yale University
入排标准
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder
- •Medically healthy
- •Ability to provide consent
排除标准
- •Unstable medical conditions
研究组 & 干预措施
Group 1
Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)
干预措施: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion
Group 2
Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)
干预措施: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion
Group 3
Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)
干预措施: 25 mg Diphenhydramine (5 min) + Normal Saline
结局指标
主要结局
Safety and tolerability of DMT in women and men with AUD
时间窗: 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
时间窗: Day 0 through Day 56
We will assess the desire of participants to drink alcohol in an experimental setting using the Alcohol Drinking Paradigm.
次要结局
- The relationship between acute psychedelic effects of DMT and alcohol consumption(Day 0 through Day 56)
- The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma(Day 0 through Day 56)
- 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 prosocial effects of DMT, plus psychotherapy, and changes in personality traits(Day 0 through Day 56)