Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation in Patients With Severe Alcohol Use Disorder: a Phase ii Trial

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized clinical trial of 10 days Cannabidiol versus placebo as an adjunctive treatment during inpatient alcohol detoxification to improve abstinence in patients with severe alcohol use disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Cannabidiol; Ethanol

Criteria

Inclusion Criteria:

• Patients hospitalized for a scheduled alcohol inpatient cessation

• Aged 18-75 years old

• Meeting DSM 5 criteria for severe AUD

• Willing to participate

• Signing a written informed consent

• Patients with current social insurance

• For childbearing age females: efficacious contraceptive method during treatment and up to seven days after treatment administration

Exclusion Criteria:

• • 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

• 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, sedatives, …..) except for tobacco and cannabis smoking.

• 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

• Reversely, cannabis use or cannabis use disorders will not be an exclusion criteria