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

Sponsor
Anders Fink-Jensen, MD, DMSci
Study ID
NCT06939088
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alcohol Abuse/Dependence
  • Alcohol Dependence
  • Alcohol Use Disorder
  • Alcoholism
  • Schizophrenia
  • Schizophrenia Disorders
  • Schizophrenia and Disorders With Psychotic Features
  • Schizophrenia and Schizophrenia Spectrum Psychosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Once weekly injections s.c. with tirzepatide (Mounjaro(R))
  • Placebo — DRUG
    Once weekly injections s.c. with placebo (BD Posiflush)

Study Details

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.

Key Dates

Start date
May 5, 2025
Status verified
Feb 2026
Primary completion
Aug 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Tirzepatide once-weekly s.c.titrated to a maximum dose of 15 mg
  • Placebo Comparator: Placebo
    Saline s.c. once-weekly

Primary Outcome Measure

Change in heavy drinking days [ Time Frame: From baseline to 16 weeks of treatment ]

Central Contacts

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