Psilocybin Recovery Intervention for Stopping Methamphetamine Use
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment Efficiency
研究概览
简要总结
The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are seeking to stop using methamphetamine. The main questions it aims to answer are:
- Do people with HIV and MeUD find psilocybin with motivational support therapy feasible and acceptable as a potential treatment?
- Is psilocybin safe and tolerable among people with HIV and MeUD?
Participants will:
- Be randomly assigned to receive a single monitored dose of either 25 mg (higher dose) or 5 mg (lower dose) psilocybin
- Have 3 preparation and 3 integration motivational support therapy visits before and after the psilocybin dosing session.
- Report their methamphetamine use prior to, during, and up to 3 months following the intervention
- Optionally receive one additional open-label 25 mg psilocybin session after the 4-week assessment, if eligible
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
- 25 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25 to 64
- •Diagnosed with HIV at least 3 months ago
- •Moderate-to-severe methamphetamine use disorder
- •Uses methamphetamine regularly and identifies it as their primary drug
- •Has a goal of quitting methamphetamine use
- •Able and willing to abstain from methamphetamine and other non-prescribed drugs for at least 24 hours prior to and throughout psilocybin dosing sessions
- •Currently living indoors with stable housing anticipated for the duration of the study
- •Has a text-capable cellphone
- •Willing to use highly effective contraception and not donate sperm throughout the study
- •Able to participate in study procedures in English
排除标准
- •History of any primary psychotic disorder (e.g., schizophrenia or schizoaffective disorder), bipolar I disorder, or certain other psychiatric conditions as determined by study assessment
- •Current moderate-to-severe opioid, alcohol, or sedative use disorder (Note: people on stable doses of buprenorphine or methadone may be eligible)
- •Currently taking certain medications that may interact with psilocybin
- •Recent use of a psychedelic drug
- •Certain significant heart, liver, or kidney conditions
- •Uncontrolled high blood presure (i.e., >150/90 mmHg)
- •History of stroke or seizure in the past year
- •Current pregnancy or breastfeeding
- •Current involvement in the criminal legal system that would be expected to interfere with study participation
- •Current or planned enrollment in a contingency management program or another investigational substance use treatment trial within the past month
- •Note: Additional eligibility criteria apply. Certain criteria and thresholds are not listed here to preserve the scientific integrity of the study.
研究组 & 干预措施
Low-Dose Psilocybin
Participants receive a single oral dose of 5 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive an optional open-label 25 mg psilocybin session with additional preparatory and integration support.
干预措施: Psilocybin 5 mg (Drug)
High-Dose Psilocybin
Participants receive a single oral dose of 25 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive a second optional open-label 25 mg psilocybin session with additional preparatory and integration support.
干预措施: Motivational Support (Behavioral)
Low-Dose Psilocybin
Participants receive a single oral dose of 5 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive an optional open-label 25 mg psilocybin session with additional preparatory and integration support.
干预措施: Motivational Support (Behavioral)
Low-Dose Psilocybin
Participants receive a single oral dose of 5 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive an optional open-label 25 mg psilocybin session with additional preparatory and integration support.
干预措施: Psilocybin 25 mg (Drug)
High-Dose Psilocybin
Participants receive a single oral dose of 25 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive a second optional open-label 25 mg psilocybin session with additional preparatory and integration support.
干预措施: Psilocybin 25 mg (Drug)
结局指标
主要结局
Recruitment Efficiency
时间窗: Screening to Baseline (approximately 35 days)
Proportion of participants who undergo in-person screening who are fully enrolled in the study and initiate treatment.
Dosing Completion
时间窗: Baseline to Dosing Visit (approximately 10 days)
Proportion of enrolled participants who receive psilocybin dosing.
Retention
时间窗: Dosing Visit to Visit 9 (approximately 28 days)
Proportion of participants receiving psilocybin who complete the end-of-double-blind-period study visit.
Acceptability
时间窗: Visit 9, approximately 38 days
Scores on an end-of-treatment acceptability questionnaire.
Adverse Events
时间窗: Dosing Visit to Visit 9 (approximately 28 days)
Number of participants who experience treatment-emergent adverse events between initial psilocybin dosing and the end-of-double-blind-period visit.
次要结局
- Methamphetamine Use (TLFB)(Baseline to Visit 9 (approximately 38 days))
研究者
Nicky Mehtani, MD, MPH
Principal Investigator
University of California, San Francisco