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Cannabidiol for reducing drinking in alcohol use disorder and modifying the effects of alcohol on the brain and the liver
EU CTIS ID: 2024-517751-13-01
What this study is testing
The primary objective of the CARAMEL study is to compare the reduction in alcohol drinking between CBD and placebo (PCB), in a population of patients with AUD and heavy drinking level at baseline (i.e., 12 standard drinks (sd)/day or more). The drinking reduction level will be defined by the total consumption in the 28 days prior to inclusion, minus the total consumption of the 28 last days of the study (weeks 8 to 12).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Being aged 18 years, or more
- Comprendre le français
- 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
You likely can't join if
- At least one day of abstinence (no alcohol drinking) during the month prior to inclusion
- 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, everolimus, tacrolimus 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…
See the full eligibility criteria
- Being aged 18 years, or more
- Comprendre le français
- 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
- At least one day of abstinence (no alcohol drinking) during the month prior to inclusion
- 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, everolimus, tacrolimus 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
- Person under tutorship or curatorship
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.