Clinical Trial

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

Study acronym: DUALPSYCHIATRY
Recruiting Phase 2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-04-14; most recent amendment 2026-02-05.
Status change: Not Yet Recruiting → Recruiting 2025-04-22
Trial Details
NCT Number NCT06939088
Lead Sponsor Anders Fink-Jensen, MD, DMSci
Conditions Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence, Alcoholism, Schizophrenia Disorders, Schizophrenia and Disorders With Psychotic Features, Schizophrenia and Schizophrenia Spectrum Psychosis, Schizophrenia
Enrollment 108 participants
Start Date 2025-05-05
Primary Completion 2028-08-01 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-10