NCT07391332尚未招募2 期
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Protocol completion rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Psychotherapy assisted by low-dose psilocybin (1 mg)
Active Comparator
干预措施: Psychotherapy assisted by low-dose psilocybin (1 mg) (Drug)
Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate)
Experimental
干预措施: Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate) (Drug)
结局指标
主要结局
Protocol completion rate
时间窗: End of study (33 months)
Proportion of randomized participants who completed all scheduled visits and procedures, including all PAP sessions/control sessions and follow-up assessments until the end of study participation.
次要结局
- Feasibility of recruitment and the proposed experimental protocol.(End of study (33 months))
- Assessement of the acceptability of the proposed experimental treatment by patients and caregivers.(Month 1)
- Assessment of personal self-efficacy (General Self-Efficacy Scale: GSES)(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(Month 1)
- Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and the Self-Compassion Scale(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)(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)(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(Month 1)
- Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and measurement of blind maintenance(Month 1)
- Clinical global impression of severity (Clinical Global Impression-Severity: CGI-S)(Month 1)
- Self-Compassion Scale (SCS)(Month 1)
- Spirituality assessment (World Health Organization Quality of Life Spirituality, Religiousness and Personal Beliefs Instrument: WHOQOL-SRPB)(Month 1)
- Analysis of daily diary(Month 1)
- Heart rate(Month 1)
- Blood pressure(Month 1)
- Expected acute effects assessment(Month 1)
- Assessment of Adverse Effects(Month 3)
- Mini International Neuropsychiatric Interview (MINI 5.0)(Month 3)
- Clinical Global Impression-Efficacy Index: CGI-IE(Month 3)
研究者
研究点 (1)
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