Psilocybin in the Treatment of Methamphetamine Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Abstinent Days
研究概览
简要总结
This trial tests whether psilocybin-assisted treatment can help adults stop using methamphetamine. Participants receive a single oral dose of psilocybin during a supervised session, paired with brief cognitive behavioral therapy, and are followed for up to six months. The study is supported by the HEAL Initiative (https://www.nih.gov/heal).
详细描述
Single-site, phased UG3/UH3 randomized, quadruple-masked, parallel-group controlled trial (target N = 42). Participants are randomized 1:1 to a single administration of psilocybin at one of two dose levels, each delivered with a manualized platform of two preparation and two integration sessions. The specific doses are withheld in this registration during the conduct of the trial to preserve masking and reduce expectancy effects, and will be reported with results. The UG3 phase (n = 12) establishes feasibility and safety; the UH3 phase (n = 30) expands enrollment with longer follow-up. Support is provided by the HEAL Initiative (https://www.nih.gov/heal).
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)
盲法说明
statistician(s)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 moderate or severe Methamphetamine Use Disorder
- •Severity of Dependence Scale score ≥ 4
- •Methamphetamine use on more than 7 of the past 30 days and more than one positive urine test before randomization
- •A goal of complete abstinence on the Thoughts About Abstinence questionnaire
- •Able to read, write, and speak English
- •A friend or family member available for post-session release
- •Good general health by history and physical
- •Confirmed pre-dose abstinence of at least 24 hours (clinically assessed)
排除标准
- •Pregnancy or breastfeeding, or not using effective contraception
- •Current psychiatric diagnoses other than a mild substance use disorder or tobacco/nicotine use disorder
- •Current hypertension (>140/90 at rest)
- •Regular use of centrally acting serotonergic medications or MAO inhibitors (washout/re-screen permitted)
- •Personal history of any psychotic or bipolar I/II disorder, or a first- or second-degree relative with such
- •Current suicidal or homicidal ideation
- •Plan to relocate within 6 months
- •Psychedelic use in the past 3 years, more than 3 lifetime psychedelic occasions, more than 3 lifetime ketamine or MDMA occasions, or any prior 5-MeO-DMT or ibogaine use
研究组 & 干预措施
Psilocybin, Dose A
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
干预措施: Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct). (Drug)
Psilocybin, Dose A
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
干预措施: Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions). (Behavioral)
Psilocybin, Dose B
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
干预措施: Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct). (Drug)
Psilocybin, Dose B
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
干预措施: Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions). (Behavioral)
结局指标
主要结局
Abstinent Days
时间窗: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Percentage of days abstinent from methamphetamine (Timeline Followback, urine-confirmed); possible range is 0% to 100%, with higher scores reflecting more abstinence.
次要结局
- Complete Abstinence(Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3))
- Methamphetamine Use Disorder in Remission(30/90-day (UG3), 30/90/180-day (UH3))
- Health-related Quality of Life(Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3))
- Self-perceived Quality of Life(Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3))
- Craving(Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3))
- Withdrawal(Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3))
- Severity of Dependence(Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3))
- Mystical-type Experience(Day of dosing (≈7 hours))
- Challenging Experience(Day of dosing (≈7 hours))
- Emotional Breakthrough(Day of dosing (≈7 hours))
- Psychological Insight(Day of dosing (≈7 hours))
研究者
Peter Hendricks
University Professor and Heersink Endowed Chair
University of Alabama at Birmingham