Cannabidiol for Reducing Drinking in Alcohol Use Disorder

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).

Eligibility

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.

Conditions2

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