Cannabidiol for Reducing Drinking in Alcohol Use Disorder

Last updated: February 26, 2025
Sponsor: Hôpital le Vinatier
Overall Status: Active - Recruiting

Phase

2

Condition

Alcohol Dependence

Addictions

Alcohol Use Disorder

Treatment

Placebo Cap/Tab

Cannabidiol oral oil

Placebo oral oil

Clinical Study ID

NCT05159830
2019-004740-30
  • Ages 18-65
  • All Genders

Study 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 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

Total Participants: 76
Treatment Group(s): 4
Primary Treatment: Placebo Cap/Tab
Phase: 2
Study Start date:
October 25, 2024
Estimated Completion Date:
December 31, 2026

Study Description

CBD has several potential therapeutic prospects in AUD. Preclinical studies now support the potential of CBD for drinking reduction in AUD subjects. Moreover, other experimental studies have found that CBD reverse the alcohol-induced steatosis process in the liver. These two experimental effects need a translational confirmation in humans through an explanatory phase 2 study. In addition, CBD could also exert neuroprotective effects that reduce the deleterious effects of alcohol on the brain. In both the liver and the brain, the idiosyncratic anti-inflammatory effects of CBD could thus strengthen the overall harm reduction allowed by drinking reduction in AUD ± ALD patients.

CBD deserves an exploratory study assessing whether the different therapeutic prospects in AUD are warranted. Moreover, because CBD is extracted from cannabis, and even if it is a CB1 antagonist with no psychotomimetic effects and no reported potential for abuse, the first pieces of evidence in AUD should confirm that CBD is safe in AUD subjects.

The CARAMEL study is a phase-2 clinical trial on 76 subjects, which aims to investigate the efficacy of CBD on reducing alcohol drinking, as well as the potential of CBD for restraining alcohol-induced brain and liver injuries, and confirm the good safety profile of CBD.

Connect with a study center

  • Centre Hospitalier Le Vinatier

    Bron, Auvergne Rhone Alpes 69678 cedex
    France

    Active - Recruiting

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