Using cannabidiol to reduce drinking in people with alcohol use disorder
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
This study is testing whether cannabidiol (CBD) can help people with alcohol use disorder drink less and protect their liver and brain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hôpital le Vinatier Academic / other |
| Locations | 1 site (Bron, Auvergne-Rhône-Alpes) |
| Trial ID | NCT05159830 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial investigates the effects of cannabidiol (CBD) on reducing alcohol consumption in individuals diagnosed with alcohol use disorder (AUD). The study aims to confirm preclinical findings that CBD can lower drinking levels and mitigate alcohol-induced damage to the liver and brain. Participants will receive either CBD or a placebo over the course of the trial, with a focus on assessing safety and efficacy. The trial will include 76 subjects aged 18 to 65 who meet specific criteria for AUD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who are fluent in French and meet the DSM-5 criteria for alcohol use disorder.
Not a fit: Patients with a history of liver cirrhosis, severe mental health disorders, or those who have abstained from alcohol in the month prior to inclusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for individuals struggling with alcohol use disorder.
How similar studies have performed: While preclinical studies have shown promising results for CBD in reducing alcohol consumption, this is the first human trial exploring its efficacy in alcohol use disorder.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being aged 18 - 65 years * Being fluent in French * 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. Exclusion Criteria: * 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.
Where this trial is running
Bron, Auvergne-Rhône-Alpes
- Centre Hospitalier Le Vinatier — Bron, Auvergne-Rhône-Alpes, France (Recruiting)
Study contacts
- Principal investigator: Benjamin ROLLAND, MD, PhD — Centre Hospitalier le Vinatier
- Study coordinator: Florelle BERTRAND
- Email: Florelle.BERTRAND@ch-le-vinatier.fr
- Phone: 00 33 4 37 91 55 40
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.