Psilocybin vs Ketamine for Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Timeline Follow-Back for Alcohol to assess change
研究概览
简要总结
This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of ketamine.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Drug/medication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the study investigators), medically unstable, current medication use that has significant potential to interact with study drug (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents, lithium, anticonvulsants, or benzodiazepines).
- •Psychiatric assessment that yields:1) history of severe suicide attempt, 2) current suicidality 3) first-degree relative with schizophrenia or schizoaffective disorder, 4) comorbid substance use disorder including cocaine, psychostimulant, or opioid use disorder within past 12 months 5) history of co-occurring psychotic episode/diagnosis including schizophrenia, schizoaffective disorder, schizophreniform, substance-induced psychosis, delusional disorder, or psychosis not otherwise specified, 6) high risk of adverse emotional or behavioral reaction based on the medical monitor's clinical evaluation that may also yield evidence of serious current stressors, a lack of meaningful social support, antisocial behavior, and/or serious personality disorders amongst other conditions.
- •Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation [QTc > .045]), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation (significantly impaired liver function), or pregnancy.
- •MRI contraindication (pacemaker, etc.)
研究组 & 干预措施
Ketamine Group (Arm 2)
receives individual psychotherapy sessions plus a (0.75 mg/kg) ketamine session
干预措施: Ketamine (Drug)
Psilocybin Group (Arm 1)
receives individual psychotherapy sessions plus a (30 mg) psilocybin session.
干预措施: Psilocybin (Drug)
结局指标
主要结局
Timeline Follow-Back for Alcohol to assess change
时间窗: Weekly, over the course of 16 weeks
Quantifies daily alcohol use
次要结局
- Resting state fMRI(Twice (before intervention, post intervention):: at week 1 and week 16)
- T1rho(Twice (before intervention, post intervention): at week 1 and week 16)
- EEG- signal complexity(Twice (before drug administration and at peak of drug experience) during week 3)
研究者
Peggy C Nopoulos
Department Chair, Psychiatry
University of Iowa