Study on Cannabidiol for Reducing Alcohol Consumption in Patients with Alcohol Use Disorder

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What is this study about?

This clinical trial is focused on studying the effects of Alcohol Use Disorder (AUD), a condition where individuals have difficulty controlling their alcohol consumption, leading to significant health and social problems. The study will explore the use of Cannabidiol (CBD), a chemical compound found in cannabis plants, as a potential treatment to help reduce alcohol consumption in individuals with AUD. Participants in the study will receive either CBD in the form of an oral solution or a placebo, which is a substance with no active medication.

The purpose of the study is to compare the reduction in alcohol drinking between those taking CBD and those taking the placebo. The study will last for a total of 16 weeks. During this time, participants will be asked to track their alcohol consumption and other health indicators. The study will begin with a period where participants’ current drinking habits are recorded, followed by the administration of either CBD or the placebo. The final weeks of the study will involve assessing changes in alcohol consumption and other health-related factors.

Throughout the study, researchers will monitor various health aspects, including the effects of alcohol on the brain and liver. This will involve looking at changes in brain structure and liver health using methods like MRI (Magnetic Resonance Imaging), which is a type of scan that provides detailed images of the body’s organs. The study aims to provide insights into whether CBD can effectively reduce alcohol consumption and improve health outcomes for individuals with AUD.

1 joining the study

Upon joining the study, the participant will be required to read the information procedure and sign the informed consent sheet.

Eligibility criteria include being 18 years or older, understanding French, and having health insurance.

Participants must meet the DSM-5 criteria for alcohol use disorder (AUD) and have an average drinking level of at least 12 standard drinks per day over the month prior to inclusion.

2 initial assessment

An initial assessment will be conducted to record the participant’s alcohol consumption over the 28 days prior to inclusion.

This assessment will use the A-TLFB, a daily self-report of alcohol drinking.

3 medication administration

Participants will be randomly assigned to receive either cannabidiol or a placebo.

The medication will be administered as an oral solution.

The dosage and frequency of administration will be determined by the study protocol.

4 study period

The study will last for 12 weeks, during which participants will continue to take the assigned medication.

Participants will be required to maintain a daily self-report of alcohol consumption using the A-TLFB.

5 final assessment

At the end of the study period, a final assessment will be conducted to measure the total alcohol consumption in the last 28 days.

The primary endpoint is the difference in alcohol consumption between the 28 days before the study and the last 28 days of the study.

6 secondary assessments

Secondary assessments will include measurements of heavy drinking days, alcohol craving scores, and alcohol use disorder scores.

Additional assessments will evaluate changes in anxiety, depression, self-confidence, quality of life, sleep quality, liver health, brain structure, and cognitive functions.

Who Can Join the Study?

Must be 18 years old or older.
Must understand French.
Must have read the information about the study and signed the consent form. This means you agree to participate after understanding what the study involves.
Must be affiliated with health insurance. This means you have health insurance coverage.
Must meet the DSM-5 criteria for AUD. AUD stands for Alcohol Use Disorder, and DSM-5 is a guide used by doctors to diagnose mental health conditions.
Must have an average drinking level of at least 12 standard drinks per day over the month before joining the study. A standard drink contains about 10 grams of alcohol, so this means consuming at least 120 grams of alcohol daily.

Who Cannot Join the Study?

Individuals with psychiatric disorders cannot participate. This means if you have mental health conditions like depression or anxiety, you may not be eligible.
Participants must not be part of a vulnerable population. This refers to groups of people who might need special protection, like children or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Le Vinatier	Bron	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Huriez	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	21.10.2024

Trial locations

Investigated drugs:

Cannabidiol

Cannabidiol (CBD) is being studied for its potential to help reduce alcohol consumption in individuals with alcohol use disorder. The trial aims to see if CBD can decrease the amount of alcohol consumed by participants who are heavy drinkers. Researchers are interested in understanding how CBD might affect the brain and liver in the context of alcohol use.

Alcohol Use Disorder – Alcohol Use Disorder (AUD) is a condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. It often involves a pattern of heavy drinking, which can lead to tolerance, withdrawal symptoms, and a strong craving for alcohol. Over time, individuals with AUD may find that they need to consume more alcohol to achieve the same effects, and they may spend a significant amount of time obtaining, using, or recovering from alcohol. The disorder can affect various aspects of life, including relationships, work, and mental health. It is often associated with other psychiatric disorders, such as anxiety and depression. The progression of AUD can vary, with some individuals experiencing periods of remission and relapse.

Trial ID:

2024-517751-13-01

Protocol code:

PHRCN2018

NCT ID:

NCT05159830

Trial Phase:

Therapeutic exploratory (Phase II)

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