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Psilocybin for Methamphetamine Use Disorder

17 sierpnia 2026 zaktualizowane przez: 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).

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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).

Typ studiów

Interwencyjne

Zapisy (Szacowany)

42

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Seher Premani, MPH
  • Numer telefonu: 205-975-7721
  • E-mail: spremani@uab.edu

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35294
        • University of Alabama at Birmingham
        • Główny śledczy:
          • Peter S Hendricks, PhD
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Psilocybin, Dose A
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
Lek: 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.
Behawioralne: 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)
Eksperymentalny: Psilocybin, Dose B
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
Lek: 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.
Behawioralne: 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)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Abstinent Days
Ramy czasowe: 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).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Complete Abstinence
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Meaning in Life
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Peter Hendricks

Współpracownicy

National Institute on Drug Abuse (NIDA)

Śledczy

  • Główny śledczy: Peter S Hendricks, PhD, University of Alabama at Birmingham

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lutego 2027

Zakończenie podstawowe (Szacowany)

1 lutego 2032

Ukończenie studiów (Szacowany)

1 lutego 2032

Daty rejestracji na studia

Pierwszy przesłany

11 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

19 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB-300017113
  • IND 121000 (Identyfikator rejestru: FDA)
  • 1UG3DA067126 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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