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Psilocybin for Methamphetamine Use Disorder

2026年8月17日 更新者：Peter Hendricks

Psilocybin in the Treatment of Methamphetamine Use Disorder

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).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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).

研究类型

介入性

注册 (估计的)

42

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Seher Premani, MPH
  • 电话号码：205-975-7721
  • 邮箱：spremani@uab.edu

研究联系人备份

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama at Birmingham
        • 首席研究员：
          • Peter S Hendricks, PhD
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 18+
  • 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)

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Psilocybin, Dose A
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
药品：Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).
The specific doses (in mg) are intentionally omitted from this registration during the conduct of the trial to preserve masking and reduce expectancy effects. The doses will be disclosed when results are reported after primary completion, by which point participants have been debriefed.
行为的：Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).
Manualized CBT, adapted from Hendricks et al. (2026; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848757)
实验性的：Psilocybin, Dose B
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
药品：Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).
The specific doses (in mg) are intentionally omitted from this registration during the conduct of the trial to preserve masking and reduce expectancy effects. The doses will be disclosed when results are reported after primary completion, by which point participants have been debriefed.
行为的：Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).
Manualized CBT, adapted from Hendricks et al. (2026; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848757)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Abstinent Days
大体时间：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.
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).

次要结果测量

结果测量
措施说明
大体时间
Complete Abstinence
大体时间：Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Complete abstinence from methamphetamine (Timeline Followback, urine-confirmed); a dichotomous (yes or no) outcome where no use whatsoever during the assessment period is coded as "yes" and any use at all during the assessment period is coded as "no."
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Methamphetamine Use Disorder in Remission
大体时间：30/90-day (UG3), 30/90/180-day (UH3)
Modified DSM-5 Methamphetamine Use Disorder in early remission (SCID-5); a dichotomous (yes or no) outcome where those who meet DSM-5 criteria for Methamphetamine Use Disorder in early remission are coded as "yes" and those who do not meet DSM-5 criteria for Methamphetamine Use Disorder in early remission are coded as "no."
30/90-day (UG3), 30/90/180-day (UH3)
Health-related Quality of Life
大体时间：Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Health-related quality of life as measured by the RAND-36 self-report measure. The RAND-36 contains 8 primary health scales (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Social functioning, Emotional well-being [mental health], Energy/fatigue [vitality], Bodily pain, and General health perception) and 2 summary scales (Physical Health Summary and Mental Health Summary) with possible scores for each scale ranging from 0 to 100. Higher scores represent better health states and outcomes.
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Self-perceived Quality of Life
大体时间：Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Self-perceived quality of life as measured by the WHOQOL-BREF self-report measure. This measure includes 4 scales (Physical, Psychological, Social, and Environment), each with a possible range from 0 to 100. Higher scores indicate a better quality of life.
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Craving
大体时间：Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Craving, as measured by the Stimulant Craving Questionnaire-Brief (STCQ-Brief), a 10-item self-report tool measuring present-moment craving for stimulants. A score is calculated by averaging all 10 items, with a possible range of 0 to 6. Higher mean scores reflect more severe craving.
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Withdrawal
大体时间：Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Methamphetamine withdrawal as measured by the Amphetamine Cessation Symptom Assessment (ACSA), a 16-item clinical rating tool used to measure the severity of amphetamine withdrawal symptoms over the preceding 24 hours. Scores range from 0 to 64, with higher scores reflecting more severe withdrawal symptoms.
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Severity of Dependence
大体时间：Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Severity of methamphetamine dependence, as measured by the Stimulant Use Disorder Severity Scale (StUDSS). The StUDSS is a new patient-reported outcome instrument measuring the severity of symptoms for stimulant use disorder. Total symptom severity is based on a sum of all items, with a possible range of 0 to 44. Higher scores reflect more severe dependence. The StUDSS also yields a categorical severity rating based on total criteria count: Mild (2 or 3 criteria), Moderate (4 or 5 criteria), or Severe (6 or more criteria).
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Mystical-type Experience
大体时间：Day of dosing (≈7 hours)
Mystical-type experience during the day of dosing as measured by the Mystical Experience Questionnaire (MEQ). The MEQ yields 4 scales: Unity, Positive Mood, Transcendence of Time and Space, and Ineffability. Possible scores for each scale range from 0 to 5 and greater scores reflect higher intensity and greater depth of the mystical experience.
Day of dosing (≈7 hours)
Challenging Experience
大体时间：Day of dosing (≈7 hours)
Challenging experience during the day of dosing as measured by the Challenging Experience Questionnaire (CEQ). The CEQ yields 7 scales: Fear, Grief, Physical Distress, Insanity, Isolation, Death, and Paranoia. Possible scores range from 0 to 5, with greater scores reflecting higher intensity and more severe degree of psychological or physical distress during the experience
Day of dosing (≈7 hours)
Emotional Breakthrough
大体时间：Day of dosing (≈7 hours)
Emotional breakthrough on the day of dosing as measured by the Emotional Breakthrough Inventory (EBI). The EBI is a 6-item scale scored using a 0 to 100 Visual Analogue Scale (VAS) for each item. The total overall score is calculated as the sum of all six items, yielding a total summed score ranging from 0 to 600. Greater scores on the EBI reflect a deeper, more complete sense of psychological resolution and catharsis.
Day of dosing (≈7 hours)
Psychological Insight
大体时间：Day of dosing (≈7 hours)
Psychological insight during the day of dosing as measured by the Psychological Insight Questionnaire (PIQ). The PIQ measure insight on 2 scales: Avoidance and Maladaptive Patterns Insights and Goals and Adaptive Patterns Insights. Scores on the 2 scales range from 0 to 5, with greater scores representing a higher intensity of acute psychological realizations gained during the experience.
Day of dosing (≈7 hours)

其他结果措施

结果测量
措施说明
大体时间
Meaning in Life
大体时间：Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Meaning in life as measured by the Meaning in Life questionnaire. This questionnaire yields 2 scales: Search for Meaning and Presence of Meaning. Scores range from 1 to 7 for both scales with greater scores reflecting exploration for existential significance (Search for Meaning) and conviction that one's life is rich with purpose (Presence for Meaning).
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Psychosocial-Spiritual Well-Being
大体时间：Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
Psychosocial-spiritual well-being as measured by the NIH Healing Experience of All Life Stressors Short Form (NIH-HEALS-SF). The NIH-HEALS-SF yields 3 scales: Deepened Connection, Active Reflection & Introspection, and Profound Trust & Acceptance. Total scores for each scale range from 1 to 5 (if computing a mean) or 3 to 15 (if computing a sum for comparison to published data). Higher scores reflect a stronger capacity for psychological resilience, emotional healing, and spiritual well-being while facing major life stressor.
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peter Hendricks

合作者

National Institute on Drug Abuse (NIDA)

调查人员

  • 首席研究员：Peter S Hendricks, PhD、University of Alabama at Birmingham

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年2月1日

初级完成 (估计的)

2032年2月1日

研究完成 (估计的)

2032年2月1日

研究注册日期

首次提交

2026年8月11日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB-300017113
  • IND 121000 (注册表标识符：FDA)
  • 1UG3DA067126 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data, metadata, and a data dictionary will be shared through an NIH-designated repository accessible via the HEAL Data Ecosystem, consistent with the study's Data Management and Sharing Plan and the HEAL Public Access and Data Sharing Policy.

IPD 共享时间框架

De-identified individual participant data and the supporting documents will become available no later than publication of the primary outcome results or the end of the funding period, whichever comes first, and will remain available indefinitely thereafter through the repository.

IPD 共享访问标准

Data will be deposited in an NIH-designated repository accessible through the HEAL Data Ecosystem. Qualified researchers may request the de-identified dataset, data dictionary, and supporting documents through the repository's data-access process. Because these are substance use disorder data, access may be controlled or registered under the repository's terms and the Certificate of Confidentiality, and a data use agreement may be required.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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