Phase
Condition
Alcohol Dependence
Addictions
Alcohol Use Disorder
Treatment
Placebo Cap/Tab
Cannabidiol oral oil
Placebo oral oil
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 overthe month prior to inclusion (i.e., a total alcohol consumption of 336standard-drinks during the 28-day assessment period prior to inclusion), using theA-TLFB.
Exclusion
Exclusion Criteria:
At least one day of abstinence (no alcohol drinking) during the month prior toinclusion
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 thanalcohol 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 normaland 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 withrifampicin, St. John's wort, Mammalian target of rapamycin (mTOR), calcineurininhibitors 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, cochlearimplant...
Known hypersensitivity to the active principle (cannabidiol) or excipients (sucralose, menthol, mannitol).
Person under tutorship or curatorship.
Study Design
Study Description
Connect with a study center
Centre Hospitalier Le Vinatier
Bron, Auvergne Rhone Alpes 69678 cedex
FranceActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.