Cannabidiol for Reducing Drinking in Alcohol Use Disorder

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: Hôpital le Vinatier
• Treatments: Cannabidiol

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.