Study on Cannabidiol as an Add-On Treatment for Patients with Severe Alcohol Use Disorder During Inpatient Alcohol Cessation

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What is this study about?

This clinical trial is focused on studying the effects of severe Alcohol Use Disorder, a condition where individuals have a strong urge to drink alcohol despite negative consequences. The study will explore the use of cannabidiol, also known as CBD, as an additional treatment to help patients who are trying to stop drinking alcohol during a planned hospital stay. The medication being tested is called Arvisol 150mg, and it will be compared to a placebo to see if it helps maintain abstinence from alcohol.

The purpose of the study is to see if using CBD can help patients stay away from alcohol for a longer period after they leave the hospital. Participants will take part in the study for about six weeks, starting with their hospital stay and continuing for a month after they are discharged. During this time, they will receive either the CBD treatment or a placebo. The study will involve regular check-ups to monitor their progress and any side effects they might experience.

Throughout the study, participants will be asked to report their alcohol use and any symptoms they experience. This information will help researchers understand if CBD can effectively support people in maintaining their abstinence from alcohol. The study aims to provide valuable insights into whether CBD can be a helpful addition to traditional treatments for severe Alcohol Use Disorder.

1 joining the study

Upon joining the study, you will be hospitalized for a scheduled alcohol cessation program. This is a necessary step to ensure a controlled environment for the trial.

2 medication administration

During your stay, you will receive a tablet called Arvisol 150mg or a placebo. This will be administered orally. The exact dosage and frequency will be determined by the study team based on your specific needs.

3 daily assessments

From day 0 to day 10, you will undergo daily assessments. These include self-reports of alcohol abstinence, symptoms checklists for side effects, and evaluations of alcohol withdrawal and craving levels.

4 urinary assessments

During your inpatient stay, two urinary assessments will be conducted to check for signs of alcohol use. These assessments will continue weekly after discharge up to week 6.

5 outpatient visits

After discharge, you will have four outpatient visits, one per week, up to week 6. During these visits, you will continue to report on alcohol use, undergo clinical examinations, and complete various scales to assess anxiety, sleep quality, and other factors.

6 final assessments

At the end of week 6, a final assessment will be conducted to evaluate your abstinence maintenance and overall progress in the study.

Who Can Join the Study?

Patients must be hospitalized for a planned stay to stop alcohol use.
Patients should be between 18 and 75 years old.
Patients must meet the criteria for severe Alcohol Use Disorder (AUD) as defined by the DSM 5, which is a guide used by healthcare professionals to diagnose mental disorders.
Patients must be willing to participate in the study.
Patients need to sign a written informed consent, which means they agree to participate after being informed about the study.
Patients must have current social insurance.
Females of childbearing age must use an effective method of birth control during the treatment and for up to seven days after the treatment ends.

Who Cannot Join the Study?

Patients with severe Alcohol Use Disorder. This means having a serious problem with alcohol, as defined by a specific set of guidelines called DSM 5.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hopital Beaujon	Clichy	France
Gyufzd Hbkognnghge Uqeryqzklbsum Pdvkw Ptujeocnqjw Ep Nxgjsqdlpnfj	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	03.07.2024

Trial locations

Investigated drugs:

Cannabidiol

Cannabidiol is a compound that comes from the cannabis plant. In this trial, it is being used as an additional treatment to help people who are trying to stop drinking alcohol. The goal is to see if it can help patients stay away from alcohol for a longer time after they leave the hospital. Cannabidiol is not the part of cannabis that makes you feel “high,” but it might have other effects that could support people in their recovery from alcohol use disorder.

Investigated diseases:

Alcohol use disorder

Alcohol Use Disorder – Alcohol Use Disorder is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. It progresses through various stages, starting with increased tolerance and leading to dependence, where the individual experiences withdrawal symptoms when not consuming alcohol. Over time, the disorder can lead to significant physical and psychological issues, including liver damage, cardiovascular problems, and cognitive impairments. The progression often involves a cycle of excessive drinking, attempts to quit, and relapses. As the disorder advances, individuals may experience a loss of control over their drinking habits and a preoccupation with alcohol. The condition can severely impact daily functioning and relationships.

Trial ID:

2024-518455-28-00

Protocol code:

APHP180619

NCT ID:

NCT05860699

Trial Phase:

Therapeutic exploratory (Phase II)

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