Cannabidiol for Reducing Drinking in Alcohol Use Disorder

Launched by HÔPITAL LE VINATIER · Dec 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a substance called cannabidiol (CBD) on people with Alcohol Use Disorder (AUD). Previous research in animals has shown that CBD may help reduce drinking and protect the liver and brain from alcohol damage. However, this is the first time researchers are looking at how CBD affects humans with AUD. The trial is currently recruiting participants aged 18 to 65 who speak French and have been drinking at least 12 standard drinks a day for the month before joining the study.

If you decide to participate, you'll be monitored closely throughout the trial. It's important to note that there are certain criteria that could make you ineligible, such as having a history of specific mental health disorders, certain medical conditions, or using other substances. Additionally, you should not have any recent use of cannabis or other cannabinoids. This trial aims to better understand how CBD can help those struggling with alcohol use, which could lead to new treatment options in the future.

Gender

ALL

Eligibility 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.