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RECRUITING
NCT06939088
PHASE2

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

Sponsor: Anders Fink-Jensen, MD, DMSci

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2025-05-05

Completion Date

2028-12-31

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DRUG

Tirzepatide

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

DRUG

Placebo

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