In short
There are currently 2 ongoing clinical trials investigating new treatments for alcohol use disorder. These studies are testing medications that may help reduce alcohol consumption and support abstinence in people struggling with alcohol addiction. The trials are being conducted in France, Italy, and Poland.
Clinical trial locations
- France
- Italy
- Poland
Study on Sodium Oxybate for Reducing Alcohol Consumption in Patients with Alcohol Addiction
This trial is investigating whether Sodium Oxybate, taken as an oral solution, can help people with alcohol addiction reduce their drinking and maintain abstinence. The study focuses on individuals who are dependent on alcohol and have high or very high levels of alcohol consumption.
Who can participate:
- Adults between 18 and 70 years old
- Body weight between 60 and 100 kg with a Body Mass Index (a measure of body fat based on height and weight) less than 40
- Current diagnosis of alcohol use disorder based on professional diagnostic criteria
- High or very high levels of alcohol consumption: for males, more than 60 grams per day (high) or more than 100 grams per day (very high); for females, more than 40 grams per day (high) or more than 60 grams per day (very high)
- At least 4 heavy drinking days per week in the month before starting the study
- No or mild alcohol withdrawal symptoms
- Women must be postmenopausal, surgically sterile, or using effective birth control
Who cannot participate:
- People who are not addicted to alcohol
- Those outside the specified age range
- Individuals who do not meet the specific health conditions required
- Those who do not meet the gender requirements
What the study involves: Participants will take Sodium Oxybate or a placebo (an inactive substance used for comparison) for a period of 12 weeks. The main goal is to measure whether the treatment reduces the number of heavy drinking days after three months. Researchers will monitor participants through regular visits to track their progress and any side effects. The medication works by affecting brain chemicals that may help reduce alcohol cravings and withdrawal symptoms.
Study on Cannabidiol for Reducing Alcohol Consumption in Patients with Alcohol Use Disorder
This trial is testing whether Cannabidiol (CBD), a chemical compound found in cannabis plants, can help reduce alcohol consumption in people with alcohol use disorder. CBD will be given as an oral solution and compared against a placebo to see which group shows greater reduction in drinking.
Who can participate:
- Adults 18 years or older
- Able to understand French
- Have health insurance coverage
- Meet professional diagnostic criteria for alcohol use disorder
- Have an average drinking level of at least 12 standard drinks per day over the month before joining (equivalent to about 120 grams of alcohol daily)
Who cannot participate:
- Individuals with psychiatric disorders such as depression or anxiety
- People who are part of vulnerable populations, such as those unable to make decisions for themselves
What the study involves: The trial lasts 16 weeks in total. Participants will be randomly assigned to receive either CBD or a placebo. Throughout the 12-week treatment period, participants will track their daily alcohol consumption. The study will measure the difference in drinking between the 28 days before starting and the last 28 days of treatment. Researchers will also assess changes in anxiety, depression, quality of life, sleep quality, liver health, brain structure, and mental function. The study uses MRI scans (detailed images of the body's organs) to examine changes in the brain and liver. CBD is thought to work by interacting with the body's endocannabinoid system, which may help reduce cravings and anxiety related to alcohol use.
Summary
Both ongoing trials are exploring innovative approaches to treating alcohol use disorder by testing medications that work on different brain systems. The Sodium Oxybate study is being conducted across three countries (France, Italy, and Poland), while the Cannabidiol study is focused in France. Both studies aim to help people with severe alcohol addiction reduce their drinking, with participants required to have high levels of alcohol consumption at the start. The trials use careful monitoring over several months to assess whether these treatments can effectively reduce heavy drinking days and support recovery. Each study excludes people with certain psychiatric conditions to ensure participant safety and clear results.
