RecruitingPhase 2NCT06939088

Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

Effect of Tirzepatide on Alcohol Intake and Reward Processing in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder


Sponsor

Anders Fink-Jensen, MD, DMSci

Enrollment

108 participants

Start Date

May 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Glucagon-like peptide-1 receptor agonists (GLP-1RAs), approved for the treatment of type 2 diabetes and obesity, have shown promise as a novel treatment for alcohol use disorder (AUD). This study aims to investigate whether the Glucose-dependent Insulinotropic Polypeptide/GLP-1RA tirzepatide will reduce alcohol consumption in patients with a dual diagnosis of AUD and schizophrenia, a population in dire need of improved treatment options. To further investigate the neurobiological underpinnings of a potential dampening effect on alcohol consumption, functional magnetic resonance imaging (fMRI) brain scans will be applied. The key anticipated outcomes include: * decreased alcohol consumption and * reduced alcohol cue-induced brain activity in the GIP/GLP-1-treated patient group compared with the placebo group. To the best of the investigators knowledge, this has never been examined before.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tirzepatide — a medication used for weight loss and type 2 diabetes — can also help reduce heavy alcohol use in people who have both schizophrenia and alcohol use disorder. There is growing interest in whether medications that affect appetite and metabolism may also reduce cravings for alcohol. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with both schizophrenia and alcohol use disorder - You have a high alcohol use score (AUDIT score above 15) - You have had at least 4 heavy drinking days within a 3-week period recently - Your BMI is 23 or higher **You may NOT be eligible if...** - You have an intellectual disability - You are currently in an acute psychotic episode (very severe symptoms) - You are subject to coercive psychiatric measures - You have conditions that make tirzepatide unsafe, such as a personal or family history of certain thyroid cancers or severe gastrointestinal problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

Once weekly injections s.c. with tirzepatide (Mounjaro(R))

DRUGPlacebo

Once weekly injections s.c. with placebo (BD Posiflush)


Locations(2)

Department of Psychiatry, Aalborg University Hospital

Aalborg, Denmark, Denmark

Psychiatric Center Copenhagen, Frederiksberg Hospital

Frederiksberg, Denmark, Denmark

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NCT06939088


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