Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder.
详细描述
The trial will take place with individuals admitted to a residential rehabilitation treatment program. The treatment protocol will consist of 4 preparatory therapy visits, 2 psilocybin sessions (25-30mg), and 8 total integration therapy visits. Primary aims assess acceptability, feasibility, and safety with a primary endpoint at the conclusion of the study intervention. An additional aim assesses preliminary efficacy for methamphetamine use disorder and overall functioning at follow-up assessments 60 and 180 days after discharge from the residential treatment program.
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
- Single (Outcomes Assessor)
盲法说明
Clinical interviewers will be blinded to condition and study timepoint.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •United States military Veteran
- •Moderate to severe methamphetamine use disorder using the DSM-V diagnostic criteria
- •Desire to cease or reduce methamphetamine use
排除标准
- •Have uncontrolled hypertension or clinically significant cardiovascular disease
- •History of seizure disorder in adulthood
- •CNS metastases or symptomatic central nervous system (CNS) infection
- •Poorly controlled diabetes mellitus
- •Taking certain medications that may interact with psilocybin
- •History of any primary persistent psychotic disorder, including schizophrenia, schizoaffective disorder, bipolar disorder with psychosis, major depressive disorder with psychosis, or schizophreniform disorder
- •History of bipolar I disorder
- •Current eating disorder with active purging
- •History of hallucinogen use disorder
- •Pregnant or breast feeding
研究组 & 干预措施
Treatment-as-Usual
Treatment-as-usual while admitted to a residential rehabilitation treatment program.
干预措施: Treatment-as-usual (Behavioral)
Psilocybin-enhanced psychotherapy
Psilocybin will be administered twice (25mg & 30mg two weeks apart) in addition to a 6-week psychotherapy protocol while admitted to a residential rehabilitation treatment program.
干预措施: Treatment-as-usual (Behavioral)
Psilocybin-enhanced psychotherapy
Psilocybin will be administered twice (25mg & 30mg two weeks apart) in addition to a 6-week psychotherapy protocol while admitted to a residential rehabilitation treatment program.
干预措施: Psilocybin (Drug)
结局指标
主要结局
Acceptability
时间窗: End of 6-week intervention; approximately 42 days
We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention.
Proportion of patients who complete the intervention and follow-up
时间窗: End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility.
次要结局
- Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up(approximately 102 days post-enrollment)
- Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up(approximately 222 days post-enrollment)
- Methamphetamine Use, urine(180 days post-discharge follow-up; approximately 222 days post-enrollment)
- Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention(approximately 42 days post-enrollment)
- Methamphetamine Use, self-report(180 days post-discharge follow-up; approximately 222 days post-enrollment)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](180 day post-discharge follow-up; approximately 222 days post-enrollment)
- Methamphetamine Use, self-report(60 days post-discharge follow-up; approximately 102 days post-enrollment)
- Methamphetamine Use, urine(60 days post-discharge follow-up; approximately 102 days post-enrollment)