Cannabidiol for reducing drinking in alcohol use disorder and modifying the effects of alcohol on the brain and the liver: a phase 2 clinical trial.- The CARAMEL Study

Eligibility criteria

• ['Being aged 18 years, or more', 'Comprendre le français', 'Having read the information procedure and signed the informed consent sheet', 'Being affiliated with health insurance', 'DSM-5 criteria for AUD (all stages) (American Psychiatric Association, 2013)', 'Average drinking level of at least 12 standard-drinks (120g of ethanol) per day over the month prior to inclusion (i.e., a total alcohol consumption of 336 standard-drinks during the 28-day assessment period prior to inclusion), using the A-TLFB'] ['At least one day of abstinence (no alcohol drinking) during the month prior to inclusion', 'Pregnancy, lactation, or insufficient contraceptive measure (precautionary measure) (See 5.2 for acceptable birth control methods)', 'Patients with cancer, HIV, pulmonary arterial hypertension, epilepsy and with rifampicin, St. John’s wort, everolimus, tacrolimus or triazole antifungal agents like posaconazole, fluconazole.', 'History of vascular accident and/or cardiac arrhythmias and/or myocardial infarction', 'Patients receiving acamprosate, naltrexone, disulfiram, nalmefene, topiramate, baclofen for AUD within 30 days prior to screening.', 'MRI contraindication: pacemaker, insulin pump, heart metal valve, cochlear implant…', 'Known hypersensitivity to the active principle (cannabidiol) or excipients', 'Person under tutorship or curatorship', 'Criteria for liver cirrhosis (Child-Pugh B or C)', 'DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, using the MINI 7.0.2', 'Current suicidality, using the MNI 7.0.2', 'Lifelong history of suicide attempts', 'Lifelong history or current DSM-5 criteria for substance use disorder (other than alcohol or nicotine) using the MINI 7.0.2', 'Any detected use of cannabis or any other cannabinoid within 60 days prior to screen', 'Patients with transaminase elevations greater than 3 times upper the limit of normal and bilirubin greater than 2 times upper the limit of normal', "Impaired medical condition (investigator's decision)"]