Using Cannabidiol to Help Patients Stop Drinking Alcohol
Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation in Patients With Severe Alcohol Use Disorder: A Phase II Trial
This study is testing if cannabidiol (CBD) can help people in detox from alcohol stay sober and feel better during their recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 12 sites (Créteil, Albert Chenevier and 11 other locations) |
| Trial ID | NCT05860699 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of cannabidiol (CBD) as an additional treatment for patients undergoing inpatient detoxification for severe alcohol use disorder. Over a period of 10 days, participants will receive either CBD or a placebo while receiving standard care, with the aim of improving abstinence rates and reducing withdrawal symptoms. The study also assesses the safety of CBD and its potential effects on anxiety and alcohol cravings. Participants will be monitored for side effects and drinking behavior during and after the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who are hospitalized for alcohol detoxification and meet the criteria for severe alcohol use disorder.
Not a fit: Patients with unstable medical or psychiatric conditions or those scheduled for long-term residential care after detoxification may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the outcomes for patients struggling with severe alcohol use disorder during detoxification.
How similar studies have performed: While the use of CBD in treating alcohol use disorder is a relatively novel approach, preliminary studies suggest potential benefits, though more research is needed to confirm efficacy.
Eligibility criteria
Show full inclusion / exclusion 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, sexually active 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 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 * Reversely, cannabis use or cannabis use disorders will not be an exclusion criteria
Where this trial is running
Créteil, Albert Chenevier and 11 other locations
- Hôpital Albert Chenevier — Créteil, Albert Chenevier, France (Recruiting)
- Hôpital Antoine Béclère — Clamart, Clamart, France (Not_yet_recruiting)
- CHU Gabriel Montpied — Clermont-Ferrand, Clermont Ferrand, France (Recruiting)
- Hôpital Louis Mourier — Colombes, Colombes, France (Withdrawn)
- Hôpital Avicenne — Bobigny, France, France (Not_yet_recruiting)
- Hôpital Fernand Widal — Paris, France, France (Recruiting)
- Hôpital Hôtel-Dieu — Paris, Paris, France (Not_yet_recruiting)
- Hôpital Cochin — Paris, Paris, France (Not_yet_recruiting)
- Hôpital Saint Anne — Paris, Paris, France (Recruiting)
- Hôpital Bichat — Paris, Paris, France (Withdrawn)
- Hôpital René Muret — Sevran, Sevran, France (Recruiting)
- Hôpital la Colombière — Montpellier, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Florence Vorspan — Département de Psychiatrie et de Médecine Addictologique, Hôpital Fernand Widal, AP-HP Inserm UMR-S 1144 Université de Paris FHU NOR-SUD
- Study coordinator: Florence VORSPAN
- Email: Florence.vorspan@aphp.fr
- Phone: 01 40 05 44 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.