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RECRUITING

NCT05159830

PHASE2

Cannabidiol for Reducing Drinking in Alcohol Use Disorder

Sponsor: Hôpital le Vinatier

View on ClinicalTrials.gov

Summary

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-10-25

Completion Date

2026-12-31

Last Updated

2025-02-27

Healthy Volunteers

Conditions

Alcohol Use Disorder

Interventions

DRUG

Cannabidiol oral oil

The CBD dosing used in the CARAMEL study will start at 40mg/d up to 600 mg/d. Oral oil contain 20 mg of CBD. 20 mg because our supplier does not have a more highly dosed oral oil.

DRUG

Placebo oral oil

Placebo of similar cannabidiol galenic form

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.

Locations (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, France