drugset / Trial / NCT06939088

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

NCT06939088

Phase 2 Recruiting 108 enrolled Anders Fink-Jensen, MD, DMSci
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-05-05
Primary completion
2028-08-01
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Tirzepatide Peptide 15 mg Subcutaneous