Psilocybin for Methamphetamine Use Disorder
Psilocybin in the Treatment of Methamphetamine Use Disorder
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Faza 2
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Seher Premani, MPH
- Numer telefonu: 205-975-7721
- E-mail: spremani@uab.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Noah Sweat, BS
- Numer telefonu: 205-996-0212
- E-mail: nsweat@uabmc.edu
Lokalizacje studiów
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35294
- University of Alabama at Birmingham
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Główny śledczy:
- Peter S Hendricks, PhD
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Kontakt:
- Seher Premani, MPH
- Numer telefonu: 205-975-7721
- E-mail: spremani@uab.edu
-
Kontakt:
- Noah Sweat, BS
- Numer telefonu: 205-996-0212
- E-mail: nsweat@uabmc.edu
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
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
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Eksperymentalny: Psilocybin, Dose A
Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
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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.
Manualized CBT, adapted from Hendricks et al. (2026; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848757)
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Eksperymentalny: Psilocybin, Dose B
Single oral dose during an 8-hour supervised session (Specific dose 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.
Manualized CBT, adapted from Hendricks et al. (2026; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848757)
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Abstinent Days
Ramy czasowe: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
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Percentage of days abstinent from methamphetamine (Timeline Followback, urine-confirmed); possible range is 0% to 100%, with higher scores reflecting more abstinence.
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Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Complete Abstinence
Ramy czasowe: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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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."
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Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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Methamphetamine Use Disorder in Remission
Ramy czasowe: 30/90-day (UG3), 30/90/180-day (UH3)
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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."
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30/90-day (UG3), 30/90/180-day (UH3)
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Health-related Quality of Life
Ramy czasowe: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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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.
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Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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Self-perceived Quality of Life
Ramy czasowe: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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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)
|
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Craving
Ramy czasowe: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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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.
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Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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Withdrawal
Ramy czasowe: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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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.
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Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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Severity of Dependence
Ramy czasowe: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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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).
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Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
|
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Mystical-type Experience
Ramy czasowe: Day of dosing (≈7 hours)
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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.
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Day of dosing (≈7 hours)
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Challenging Experience
Ramy czasowe: Day of dosing (≈7 hours)
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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
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Day of dosing (≈7 hours)
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Emotional Breakthrough
Ramy czasowe: Day of dosing (≈7 hours)
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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.
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Day of dosing (≈7 hours)
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Psychological Insight
Ramy czasowe: Day of dosing (≈7 hours)
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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.
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Day of dosing (≈7 hours)
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Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Meaning in Life
Ramy czasowe: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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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).
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Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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Psychosocial-Spiritual Well-Being
Ramy czasowe: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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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.
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Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3)
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Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Peter S Hendricks, PhD, University of Alabama at Birmingham
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Zaburzenia wywołane chemicznie
- Zaburzenia związane z substancjami
- Związki heterocykliczne
- Związki heterocykliczne, 2-ring
- Związki heterocykliczne, sterowanie stopieniem
- Alkaloidy
- Indole
- Technologia, przemysł i rolnictwo
- Alkaloidy indole
- Indolizicyny
- Indolizyny
- Tryptaminy
- Projekt i Budowa Obiektu
- Architektura
- Psilocybina
- Podłogi i Wykładziny Podłogowe
Inne numery identyfikacyjne badania
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)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
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
Bada produkt urządzenia regulowany przez amerykańską FDA
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