Cannabidiol for Reducing Drinking in Alcohol Use Disorder

Exclusion Criteria16

• At least one day of abstinence (no alcohol drinking) during the month prior to inclusion
• 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)
• 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, Mammalian target of rapamycin (mTOR), calcineurin inhibitors 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 (sucralose, menthol, mannitol).
• Person under tutorship or curatorship.