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

Exclusion Criteria

• •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