Study on Semaglutide’s Effect on Reducing Alcohol Intake in Patients with Alcohol Use Disorder and Obesity

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What is this study about?

This clinical trial is focused on studying the effects of a medication called semaglutide on individuals with Alcohol Use Disorder who also have obesity. Alcohol Use Disorder is a condition where a person has difficulty controlling their alcohol consumption, and obesity is when a person has an excessive amount of body fat. The medication being tested, semaglutide, is a type of drug known as a glucagon-like peptide 1 (GLP-1) receptor agonist, which is commonly used to help manage weight and blood sugar levels. In this study, semaglutide is being compared to a placebo, which is a substance with no active medication, to see if it can help reduce alcohol intake in people with these conditions.

The purpose of the study is to determine if semaglutide can effectively reduce the amount of alcohol consumed by participants over a period of 26 weeks. Participants will receive semaglutide or a placebo through an injection under the skin, using a pre-filled pen. The study will monitor changes in alcohol consumption, including the number of days participants drink heavily, the total amount of alcohol consumed, and the number of days without alcohol. Additionally, the study will observe changes in body weight, blood pressure, and other health indicators.

Throughout the study, participants will be regularly assessed to track their progress and any changes in their health. The trial aims to provide valuable insights into whether semaglutide can be a beneficial treatment for reducing alcohol intake in individuals with Alcohol Use Disorder and obesity. The study is expected to conclude in 2026, with results helping to inform future treatment options for these conditions.

1 joining the study

Upon joining the study, you will be asked to provide informed oral and written consent. This means you agree to participate after understanding the study’s purpose and procedures.

You must meet certain criteria, such as being diagnosed with alcohol use disorder and having a body mass index (BMI) of 30 or higher. Your age should be between 18 and 70 years.

2 initial assessment

An initial assessment will be conducted to evaluate your current health status and alcohol consumption patterns. This includes measuring your alcohol intake over the past 30 days.

Your alcohol consumption will be assessed using the Timeline Followback (TLFB) method, which involves recalling your drinking habits over a specified period.

3 treatment phase

During the treatment phase, you will receive the medication semaglutide through a subcutaneous injection. This means the medication is injected under the skin.

The dosage of semaglutide will be gradually increased to a maximum of 2.4 mg, administered once a week, over a period of 26 weeks.

4 monitoring and follow-up

Throughout the study, your alcohol consumption and health parameters will be regularly monitored. This includes changes in your drinking habits, body weight, and other health indicators.

You will be asked to attend regular follow-up visits to assess your progress and any changes in your condition.

5 end of study evaluation

At the end of the 26-week treatment period, a final evaluation will be conducted to measure the changes in your alcohol consumption and overall health.

The study aims to determine if semaglutide effectively reduces alcohol intake in individuals with alcohol use disorder and obesity.

Who Can Join the Study?

Provide informed consent, which means you agree to participate after understanding the study details, both orally and in writing.
Have a diagnosis of alcohol dependence according to the International Classification of Diseases 10 (ICD-10) and alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Have an Alcohol Use Disorder Identification Test (AUDIT) score greater than 15. This is a questionnaire that helps identify alcohol use problems.
Have a Body Mass Index (BMI) of 30 or higher. BMI is a measure of body fat based on height and weight.
Be between the ages of 18 and 70, inclusive.
Engage in heavy alcohol drinking, defined as drinking more than 6 days with alcohol consumption over 4 units (48 grams of alcohol) for women and 5 units (60 grams of alcohol) for men during a consecutive 30-day period, within 40 days before the start of the study. This is measured by the Timeline Followback (TLFB) method, which is a way to track alcohol consumption over time.

Who Cannot Join the Study?

Patients who are not diagnosed with Alcohol Use Disorder cannot participate.
Patients who do not have comorbid obesity (obesity occurring alongside another condition) cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Frederiksberg Hospital	Frederiksberg	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	15.05.2023

Trial locations

Investigated drugs:

Semaglutide is a medication that is being studied to see if it can help reduce alcohol intake in people who have Alcohol Use Disorder and are also dealing with obesity. It works by mimicking a natural hormone in the body that helps control appetite and blood sugar levels. Researchers are interested in finding out if this medication can also help people drink less alcohol by affecting the brain areas that control cravings and addiction.

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 often begins with occasional drinking that gradually increases in frequency and quantity. Over time, individuals may develop a tolerance, requiring more alcohol to achieve the same effects. As the disorder progresses, individuals may experience withdrawal symptoms when not drinking. The condition can lead to significant disruptions in daily life, affecting relationships, work, and overall health. It is a chronic condition that can vary in severity, with some individuals experiencing periods of remission and relapse.

Trial ID:

2023-503371-25-00

Trial Phase:

Therapeutic exploratory (Phase II)

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