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TerminatedPhase 2
Cannabidiol for Reducing Drinking in Alcohol Use Disorder
Key facts
- Who runs it
- Hôpital le Vinatier
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 10 people enrolled
- Started
- 25 Oct 2024
- Ended
- 26 Feb 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Cannabidiol oral oil
- Placebo oral oil
- Record updated
- 12 June 2026
- Why it stopped
- Péremption des unités de traitement prévue début juin 2026. Compte tenu des délais de traitement, aucune administration ne sera plus possible après le 1 février 2026. Ces facteurs ne permettent plus de garantir la poursuite des inclusions.
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- At least one day of abstinence (no alcohol drinking) during the month prior to inclusion
- Any detected use of cannabis or any other cannabinoid within 60 days prior to screen
- Patients receiving acamprosate, naltrexone, disulfiram, nalmefene, topiramate, baclofen for AUD within 30 days prior to screening
- DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, using the MINI 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
- Impaired medical condition (investigator's decision)
- 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
- MRI contraindication: pacemaker, insulin pump, heart metal valve, cochlear implant…
- Known hypersensitivity to the active principle (cannabidiol) or excipients (sucralose, menthol, mannitol)
- Patients with transaminase elevations greater than 3 times upper the limit of normal and bilirubin greater than 2 times upper the limit of normal
- Criteria for liver cirrhosis (Child-Pugh B or C)
- Current suicidality, using the MNI 7.0.2
- Pregnancy, lactation, or insufficient contraceptive measure (precautionary measure) (See 5.2 for acceptable birth control methods)
- Person under tutorship or curatorship
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Cannabidiol (CBD)Treatment being tested
CBD Group from 20mg x 2/day up to 600mg/day
Treatment: Cannabidiol oral oil
- PLACEBO (PCB)Placebo, for comparison
PCB Group from 20mg x 2/day up to 600mg/day
Treatment: Placebo oral oil
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cannabidiol for Reducing Drinking in Alcohol Use Disorder and Modifying the Effects of Alcohol on the Brain and the Liver: a Phase 2 Clinical Trial.-The CARAMEL Study
- Record updated
- 12 June 2026