Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study

Обзор

The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomized clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder. Feasibility will be assessed by estimating the ability to retain participants until the end of the protocol. Other objectives of the study will be to generate preliminary efficacy data, identify clinical factors potentially associated with the intensity of the psychedelic experience (which determines the expected therapeutic effect), and conduct a preliminary assessment of the safety of the treatment under study.

Вмешательства

• Препарат Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate)
  The first session of psilocybin PEX010 administration will use a moderately high dose of psilocybin, i.e., 25 mg. The dose may be increased to 40 mg during the second administration session in the experimental group, depending on the response during the previous session, as assessed by the Mystical Experience Questionnaire-30 (MEQ-30).
• Препарат Psychotherapy assisted by low-dose psilocybin (1 mg)
  The first session of psilocybin PEX010 administration will use a very low dose of 1 mg in the control group. During the second administration session, the dose will be maintained at 1 mg.

Первичные конечные точки

• Protocol completion rate [Срок оценки: End of study (33 months)]

Вторичные конечные точки (12)

• Feasibility of recruitment and the proposed experimental protocol. [Срок оценки: End of study (33 months)]
• Assessement of the acceptability of the proposed experimental treatment by patients and caregivers. [Срок оценки: Month 1]
• Assessment of personal self-efficacy (General Self-Efficacy Scale: GSES) [Срок оценки: Month 1]
• Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and the WHOQOL-SRPB spirituality score [Срок оценки: Month 1]
• Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and the Self-Compassion Scale [Срок оценки: Month 1]
• Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and treatment expectations (Credibility/Expectancy Questionnaire: CEQ) [Срок оценки: Month 1]
• Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and personal self-efficacy (General Self-Efficacy Scale: GSES) [Срок оценки: Month 1]
• Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and average dose of psilocybin administered during the two sessions [Срок оценки: Month 1]
• Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and measurement of blind maintenance [Срок оценки: Month 1]
• Clinical global impression of severity (Clinical Global Impression-Severity: CGI-S) [Срок оценки: Month 1]
• Self-Compassion Scale (SCS) [Срок оценки: Month 1]
• Spirituality assessment (World Health Organization Quality of Life Spirituality, Religiousness and Personal Beliefs Instrument: WHOQOL-SRPB) [Срок оценки: Month 1]

Критерии участия

Критерии включения

• Men and women aged 18 years or older
• With a confirmed diagnosis of current gambling disorder (diagnostic criteria according to DSM-5), regardless of severity.
• Able to complete self-assessment questionnaires
• Willing to start addiction treatment, or for whom treatment already undertaken is not sufficient
• Willing to undergo a blood test and ECG
• Written and oral comprehension of French
• Having signed an informed consent form before any procedure under study
• Affiliated with a French social security system
• Women of childbearing age with a negative pregnancy test and highly effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations in Appendix 7)
• Men of childbearing age using effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations).
• Negative result on urinary toxicology screening
• In the case of psychotropic treatment (excluding nicotine replacement therapy): stabilization of dosage or initiation for more than 1 month.

Критерии исключения

• Medical conditions that would prevent safe participation in the trial (epilepsy, significantly impaired liver function (TP<50%), significantly impaired kidney function (GFR<90 mL/min), coronary artery disease, history of arrhythmia, heart failure, uncontrolled hypertension, history of stroke, severe asthma, hyperthyroidism, narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder neck obstruction).
• Serious ECG abnormalities (including QTc prolongation = corrected QT)
• Current or past psychotic or bipolar disorder
• Other unstable psychiatric disorder
• Family history (first-degree relatives) of psychotic disorder or type 1 bipolar disorder
• Current high risk of suicide (according to the MINI 5.0 suicide risk module)
• History of hallucinogen use disorder or any use in the past year
• Current alcohol use disorder with a history of withdrawal symptoms
• Extreme thinness (BMI < 16.5) or obesity (BMI > 30)
• Major cognitive impairment (Mini-Mental State Examination score < 26)
• Allergy or hypersensitivity to psilocybin or any of the excipients contained in the investigational drug
• Taking UGT1A9, UGT1A10, ALDH, or ADH inhibitors
• Pregnancy or breastfeeding
• Current protective measures (guardianship and legal protection)
• Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical progression

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Nantes University Hospital — Nantes

Идентификаторы

NCT: NCT07391332 · RC25_0105 · 2025-522743-18-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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