Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Heavy drinking
研究概览
简要总结
The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).
详细描述
The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing.
A total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community. Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high (N=64) or low (N=64) psilocybin doses. All participants will complete a baseline session consisting of clinical, behavioral, and neuroimaging measures. Following the single dosing session, participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and 12-weeks post-dosing
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-5 AUD criteria of at least moderate severity
- •Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days
- •Desire to decrease alcohol consumption
- •Limited lifetime hallucinogen use
排除标准
- •Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months
- •Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis
- •Active suicidal ideation or serious attempt within past 3 years
- •Currently pregnant, nursing, or trying to become pregnant
- •Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test
研究组 & 干预措施
High Dose (25mg)
PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions
干预措施: Psilocybin (Drug)
Low dose (1mg)
PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions
干预措施: Psilocybin (Drug)
结局指标
主要结局
Heavy drinking
时间窗: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Percent heavy drinking days (TLFB)
次要结局
- Cognitive flexibility(Change from baseline to 1-, 4-, and 12-weeks post-dosing)
- Depression(Change from baseline to 1-, 4-, and 12-weeks post-dosing)
- Resting state functional connectivity(Change from baseline to 1-week post-dosing)
- Abstinence(Change from baseline to 1-, 4-, and 12-weeks post-dosing)
- Biomarkers of alcohol consumption(Change from baseline to 1-, 4-, and 12-weeks post-dosing)
- Alcohol cue reactivity(Change from baseline to 1-, 4-, and 12-weeks post-dosing)
- Quality of life(Change from baseline to 1-, 4-, and 12-weeks post-dosing)
- Anxiety(Change from baseline to 1-, 4-, and 12-weeks post-dosing)
- Glutamate levels(Change from baseline to 1-week post-dosing)
- GABA levels(Change from baseline to 1-week post-dosing)