NCT05646303进行中（未招募）2 期
A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
Clairvoyant Therapeutics12 个研究点 分布在 2 个国家目标入组 128 人开始时间: 2022年5月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
- 试验地点
- 12
- 主要终点
- Reduction in the number of Heavy Drinking Days
研究概览
简要总结
The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are:
- Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy?
- Is treatment with psilocybin and therapy safe for participants?
Participants will
- Attend 13 study visits
- Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo
- Record their daily alcohol consumption on study specific device
Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator.
- •Expressed a wish to reduce or stop alcohol consumption.
- •Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.
排除标准
- •Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode. Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score >19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders.
- •Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session.
- •History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses.
研究组 & 干预措施
Psilocybin
Experimental
2 oral doses of 25mg psilocybin capsules
干预措施: Psilocybin (Drug)
Placebo
Placebo Comparator
2 oral doses of placebo (microcrystalline cellulose) capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in the number of Heavy Drinking Days
时间窗: 8 weeks
Mean number of HDD from V5 (baseline) measured monthly (4 weeks) over the treatment period (Week 8), where heavy drinking is defined as the consumption of ≥60 g alcohol/day (if male) or ≥40 g alcohol/day (if female).
次要结局
未报告次要终点
研究者
研究点 (12)
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