Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH

Exclusion Criteria14

• Patients already scheduled for long term residential care after acute alcohol inpatient detoxification, not able to maintain the outpatient follow up
• Patients not willing to attend post-discharge visits whatever the reason
• Any unstable medical condition at entry, such as delirium, acute hepatic failure, hypokalaemia, liver cirrhosis whatever the stage, acute or chronic severe renal failure or any acute psychiatric condition
• Liver enzymes (ALT and/or AST) above 3 times the upper limit of normal and/or bilirubin above 2 times the upper limit of normal
• Current medication or need for medication with treatments metabolized by CYP 2C19 or CYP3A4 or UGT enzymes and having strong inhibitor/inducer properties (see list above), and/or current medication or need for medications containing valproate and derivates
• Any medical history of epileptic seizure
• Patients with current or past history of cardiac arrhythmias, myocardial infarction and stroke
• Any history of suicidal attempt in the past 5 years or a score ≥1 to the Suicidal Ideation Attributes Scale (SIDAS)
• To facilitate efficacy data interpretation, patients currently receiving or wanting to receive another approved pharmacological treatment aimed at alcohol abstinence maintenance (acamprosate, baclofene, disulfiram, nalmefene, naltrexone).
• Other major current DSM 5 severe substance use disorder (like opiates, cocaine, amphetamines, ...) except for tobacco, cannabis smoking and benzodiazepines use disorders
• Pregnancy and breast feeding
• Known hypersensitivity to the active substance or to any of the excipients (including PEG)
• Patients under guardianship
• Patients in exclusion periods of other trials