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

2019-004740-30

The non-psychotomimetic cannabis compound cannabidiol (CBD) has been found effective for reducing alcohol drinking in mice. Moreover, other experimental studies have found that CBD reduced alcohol-induced steatosis in the liver, and reduced alcohol-related injury in the brain. Despite these promising results from animal data, no human study has been conducted yet in alcohol use disorder (AUD).

2024-06-01

2024-09-30

2024-12-31

Not yet recruiting

Early phase I

76

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'CARAMEL is a phase-2, national, multi-site, interventional (category 1), double-blind, randomized, placebo-controlled trial, conducted in 76 subjects.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'PANAXIA Pharmaceutical Industries Ltd will produce tablets of Cannabidiol and Placebo of similar galenic form. They will be responsible for the pharmaceutical analyses of the product.\n\nEurofins-LC2 will import the tablets after authorization from the ANSM, and will relabeled individual vials for each participant, and regular dispatching into the hospital pharmacy.\n\nLocal hospital pharmacies will be in charge to deliver treatment individual vials to the investigators for dispensing.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 76, 'type': 'ESTIMATED'}}

2024-02-14