Study on the Effects of Tirzepatide on Reducing Alcohol Intake in Patients with Schizophrenia and Alcohol Use Disorder

2 1 1

What is this study about?

This clinical trial is focused on individuals diagnosed with schizophrenia and alcohol use disorder. The study aims to explore whether a medication called tirzepatide, also known by its code name LY3298176, can help reduce alcohol consumption in these patients. Tirzepatide is administered as a solution for injection using a pre-filled pen, and it is compared to a placebo to assess its effectiveness.

Participants in the study will receive either tirzepatide or a placebo for a period of up to 26 weeks. The study will monitor changes in alcohol consumption, specifically looking at the number of heavy drinking days, which are defined as days with a high intake of alcohol. Additionally, the study will evaluate other factors such as alcohol cravings, overall alcohol consumption, and quality of life. The effects of tirzepatide on symptoms of schizophrenia and other health parameters will also be assessed.

The trial will involve regular assessments to track progress, including the use of questionnaires and tests to measure alcohol use and mental health. Some participants may also undergo additional evaluations, such as fMRI scans, to study brain activity related to alcohol cues. The goal is to determine if tirzepatide can provide a beneficial treatment option for individuals with both schizophrenia and alcohol use disorder.

1 beginning of the trial

Upon joining the study, you will receive a detailed explanation of the trial procedures and what to expect during the study period. This includes information about the medication, its administration, and the schedule of visits and assessments.

2 medication administration

You will be administered the medication called tirzepatide through a subcutaneous injection. This means the medication is injected under the skin using a pre-filled pen called Mounjaro. The dosage may vary, and you will be informed about the specific dose you will receive, which could be 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per dose.

The injections will be given once a week for a period of 16 weeks. You will be monitored for any side effects or reactions to the medication.

3 regular assessments

Throughout the trial, you will undergo regular assessments to monitor your health and the effects of the medication. These assessments will include measuring changes in alcohol consumption, using a method called the Timeline Followback (TLFB), which helps track your drinking patterns.

Other assessments will include checking your weight, waist circumference, blood pressure, and various blood tests to monitor your overall health and any changes in your condition.

4 mid-trial evaluation

At the 16-week mark, a comprehensive evaluation will be conducted to assess the primary outcomes of the trial. This includes measuring the change in the number of heavy drinking days and other health parameters.

For some participants, additional tests such as brain imaging (fMRI) may be conducted to study changes in brain activity related to alcohol cues.

5 continuation of treatment

After the initial 16 weeks, the treatment may continue for an additional 10 weeks, making the total duration of the trial 26 weeks. During this period, the same assessments and monitoring will continue to ensure your safety and to gather more data on the effects of the medication.

6 end of the trial

At the end of the 26-week period, a final evaluation will be conducted. This will include all the assessments performed during the trial to determine the overall impact of the medication on your alcohol consumption and health.

You will receive a summary of the findings related to your participation in the trial, and any further steps or recommendations will be discussed with you.

Who Can Join the Study?

Informed Consent: The patient must agree to participate by providing both spoken and written permission.
Diagnosis: The patient must have been diagnosed with both alcohol dependence and alcohol use disorder, as well as schizophrenia spectrum disorder, according to specific medical guidelines (ICD-10 and DSM-5).
AUDIT Score: The patient must have a score greater than 15 on the Alcohol Use Disorder Identification Test, which is a questionnaire that helps identify alcohol problems.
Body Mass Index (BMI): The patient must have a BMI of 23 or higher. BMI is a measure of body fat based on height and weight.
Age Range: The patient must be between 18 and 70 years old, including both ages.
Heavy Alcohol Consumption: The patient must have had 4 or more days of heavy drinking within a 21-day period during the 28 days before the study starts. Heavy drinking is defined as consuming 4 or more units of alcohol (48 grams) for women and 5 or more units (60 grams) for men in one day. This will be checked using a method called the Timeline Followback (TLFB).

Who Cannot Join the Study?

Patients who do not have a diagnosis of schizophrenia and alcohol use disorder cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not willing or able to comply with the study procedures cannot participate.
Patients who have any other medical condition that the study doctors think might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a history of severe allergic reactions to any of the study medications cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Frederiksberg Hospital	Frederiksberg	Denmark
Rvmutn Nluudooffsi	Aalborg	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Tirzepatide is a medication being studied for its potential effects on reducing alcohol consumption in people who have both schizophrenia and alcohol use disorder. It is designed to help manage blood sugar levels in people with type 2 diabetes, but researchers are exploring whether it can also help reduce the desire to drink alcohol. In this trial, the focus is on understanding how tirzepatide might change the way the brain processes rewards, which could influence drinking behavior.

Investigated diseases:

Schizophrenia – Schizophrenia is a chronic mental disorder that affects how a person thinks, feels, and behaves. It is characterized by episodes of psychosis, which may include hallucinations, delusions, and disorganized thinking. Individuals with schizophrenia may experience a reduced ability to function in daily life. The progression of the disease can lead to periods of remission and relapse. Over time, symptoms can become more severe and persistent. Cognitive impairments and negative symptoms, such as lack of motivation and social withdrawal, may also develop.

Alcohol Use Disorder – Alcohol Use Disorder (AUD) 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. As the disorder progresses, individuals may develop a tolerance, requiring more alcohol to achieve the same effects. Withdrawal symptoms can occur when alcohol use is reduced or stopped. Over time, the disorder can lead to significant physical and psychological health issues. The progression of AUD can vary, with some individuals experiencing periods of heavy use and others maintaining a more consistent pattern of drinking.

Trial ID:

2024-518608-28-00

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effects of Tirzepatide on Reducing Alcohol Intake in Patients with Schizophrenia and Alcohol Use Disorder

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?