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Psilocybin for Methamphetamine Use Disorder

2026년 8월 17일 업데이트: 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).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

42

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Seher Premani, MPH
  • 전화번호: 205-975-7721
  • 이메일: spremani@uab.edu

연구 연락처 백업

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35294
        • University of Alabama at Birmingham
        • 수석 연구원:
          • Peter S Hendricks, PhD
        • 연락하다:
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Psilocybin, Dose A
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
의약품: 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.
행동: 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)
실험적: Psilocybin, Dose B
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
의약품: 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.
행동: 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)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Abstinent Days
기간: 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).

2차 결과 측정

결과 측정
측정값 설명
기간
Complete Abstinence
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

기타 결과 측정

결과 측정
측정값 설명
기간
Meaning in Life
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Peter Hendricks

협력자

National Institute on Drug Abuse (NIDA)

수사관

  • 수석 연구원: Peter S Hendricks, PhD, University of Alabama at Birmingham

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 2월 1일

기본 완료 (추정된)

2032년 2월 1일

연구 완료 (추정된)

2032년 2월 1일

연구 등록 날짜

최초 제출

2026년 8월 11일

QC 기준을 충족하는 최초 제출

2026년 8월 17일

처음 게시됨 (실제)

2026년 8월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 17일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB-300017113
  • IND 121000 (레지스트리 식별자: FDA)
  • 1UG3DA067126 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다