TerminatedPhase 2

Cannabidiol for Reducing Drinking in Alcohol Use Disorder

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.

France10 participantsStarted 2024-10-25

Plain-language 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).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 w…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the total consumption of alcohol (in standard-drinks, sd) in the 28 last days (week 8 to week 12) of the study, using the Alcohol Timeline Followback (A-TLFB) daily self-report of alcohol drinking

Timeframe: Five months

Trial details

NCT IDNCT05159830

SponsorHôpital le Vinatier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-26

View on ClinicalTrials.gov More Alcohol Use Disorder trials