DRY EXTRACT FROM PSILOCYBE CUBENSIS (15-25:1), EXTRACTION SOLVENT: METHANOL for Gambling disorder

Inclusion criteria

• {"criterion_text":"- Men and women aged 18 or over"}
• {"criterion_text":"- If taking psychotropic medication (excluding nicotine replacement therapy): dosage stabilized or treatment started more than one month ago."}
• {"criterion_text":"- In whom the current diagnosis of gambling disorder has been confirmed (diagnostic criteria according to DSM-5), regardless of the level of severity"}
• {"criterion_text":"- Able to complete self-assessment questionnaires"}
• {"criterion_text":"- Volunteers willing to start addiction treatment, or for whom the treatment already undertaken is not sufficient"}
• {"criterion_text":"- Agreeing to a blood test and an electrocardiogram"}
• {"criterion_text":"- Written and oral comprehension of French"}
• {"criterion_text":"- Having signed an informed consent form prior to any procedure under consideration"}
• {"criterion_text":"- Affiliated with a French social security system"}
• {"criterion_text":"- Negative result in urinary toxicology screening"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Men of childbearing age with effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations in Appendix 7)."}

Exclusion criteria

• {"criterion_text":"- 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)."}
• {"criterion_text":"- Major cognitive impairment (Mini-Mental State Examination score < 26)"}
• {"criterion_text":"- Knewn allergy or hypersensitivity to psilocybin or any of the excipients contained in the experimental drug"}
• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- Current protective measure (guardianship and judicial protection)"}
• {"criterion_text":"- Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical progression"}
• {"criterion_text":"- Serious ECG abnormalities (including prolongation of the QTc interval = corrected QT)"}
• {"criterion_text":"- Current or past psychotic or bipolar disorder"}
• {"criterion_text":"- Other unstable psychiatric disorder"}
• {"criterion_text":"- Family history (first-degree relatives) of psychotic disorder or type 1 bipolar disorder"}
• {"criterion_text":"- High current suicide risk (according to the MINI 5.0 suicide risk module)"}
• {"criterion_text":"- History of hallucinogen use disorder or any use in the past year"}
• {"criterion_text":"- Current alcohol use disorder with a history of withdrawal symptoms"}
• {"criterion_text":"- Extreme thinness (BMI < 16.5) or obesity (BMI > 30)"}
• {"criterion_text":"- Taking inhibitors of UGT1A9, UGT1A10, ALDH, and ADH"}

Primary endpoints

• {"endpoint_text":"- Protocol completion rate, defined as the 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.","definition_or_measurement_approach":"Measured as the proportion of randomized participants who completed all scheduled visits and procedures, including all psychedelic-assisted psychotherapy (PAP) sessions or control sessions and follow-up assessments until end of participation."}

Secondary endpoints

• {"endpoint_text":"- Changes in mean scores (+ standard deviations) or proportions, in each arm, between baseline assessment (V0) and post-treatment assessment: - Personal self-efficacy (General Self-Efficacy Scale: GSES); - Clinical Global Impression-Severity (CGI-S); - self-compassion (Self-Compassion Scale: SCS); - spirituality (WHOQOL-SRPB);- intensity, frequency, and duration of craving episodes and daily journaling.","definition_or_measurement_approach":"Measured as changes in mean scores or proportions from baseline to post-treatment for listed scales (GSES, CGI-S, SCS, WHOQOL-SRPB) and measures of craving (intensity, frequency, duration) and daily journaling."}
• {"endpoint_text":"- Correlation between the intensity of the psychedelic experience, measured by the MEQ-30 score obtained post-administration, and the mean scores (+ standard deviations) or proportions at baseline of the following variables in the experimental arm: spirituality (WHOQOL-SRPB); self-compassion (SCS); treatment expectations (CEQ at baseline); personal self-efficacy (GSES); average dose of IMP administered during the two sessions; measurement of blind maintenance.","definition_or_measurement_approach":"Correlation analysis between post-administration MEQ-30 score and baseline measures (WHOQOL-SRPB, SCS, CEQ, GSES), average administered IMP dose over two sessions, and assessment of blind maintenance."}
• {"endpoint_text":"- Average scores (+ standard deviations) or proportions, in each arm: of HR and BP, assessed during administration sessions; expected acute effects (17-item behavior and mood observation grid), assessed during administration sessions; number, type, severity, and attributability of AEs (excluding expected acute effects), assessed during administration sessions and throughout the study;increased risk of suicide;therapeutic index and clinical improvement.","definition_or_measurement_approach":"Measured as average heart rate and blood pressure during administration sessions; acute effects via 17-item observation grid; adverse events recorded by number/type/severity/imputability during sessions and study-wide; suicide risk changes and therapeutic index/clinical improvement assessments."}
• {"endpoint_text":"- Recruitment feasibility validated if the goal of participants within the planned inclusion period is achieved (CONSORT diagram ; participants continuing treatment to the end in each arm;Assessment of blind maintenance)","definition_or_measurement_approach":"Feasibility assessed by achieving recruitment target (30 participants), CONSORT diagram metrics (screened/eligible/included), proportions continuing treatment to end in each arm, and blind maintenance evaluation."}
• {"endpoint_text":"- self-reported acceptability by patients and caregivers: duration, number, and frequency of sessions; reasons for refusal to participate by eligible patients and dropouts","definition_or_measurement_approach":"Acceptability measured by self-report from patients and caregivers regarding session duration/number/frequency and documenting reasons for refusal or dropout."}

Methods

• Recruitment arrangements (document: K1_Recruitment arrangements) — document present; country: France.
• Poster (document: K2_Recruitment material_poster) — channel: poster; target audience: potential participants with gambling disorder in France.
• Social networks (document: K2_Recruitment material_social networks) — channel: social media; target audience: potential participants with gambling disorder in France.

France

Earliest CTIS Part Ii Submission Date

03-11-2025

Latest Decision Or Authorization Date

21-01-2026

Processing Time Days

79

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France