Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06939088

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

Led by Anders Fink-Jensen, MD, DMSci · Updated on 2026-02-10

108

Participants Needed

2

Research Sites

190 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide oral and written informed consent
  • Diagnosed with alcohol dependence according to ICD-10 and alcohol use disorder as per DSM-5
  • Diagnosed with schizophrenia spectrum disorder according to ICD-10 and DSM-5
  • Alcohol Use Disorder Identification Test (AUDIT) score greater than 15
  • Body Mass Index (BMI) of 23 kg/m² or higher
  • Age between 18 and 70 years inclusive
  • At least 4 heavy drinking days within a consecutive 21-day period in the 28 days before baseline, defined as 4+ units for women or 5+ units for men per day
Not Eligible

You will not qualify if you...

  • Diagnosis of intellectual disability
  • Acute psychosis with a Clinical Global Impression-Severity score of 6 or 7
  • Current use of coercive measures, including court-ordered treatment
  • Evidence of current severe suicidal behavior
  • History of delirium tremens or alcohol withdrawal seizures
  • Clinical Institute Withdrawal Assessment of Alcohol Scale score greater than 9 at baseline
  • Severe neurological diseases, including severe traumatic brain injury
  • Type 1 or 2 diabetes
  • Pregnant or breastfeeding women, or women planning pregnancy within 6 months without highly effective contraception
  • Impaired liver function with transaminases more than three times the upper limit
  • Impaired renal function with eGFR below 50 mL/min or plasma creatinine above 150 µmol/L
  • History of acute or chronic pancreatitis or amylase levels more than twice the upper limit
  • Previous medullary thyroid carcinoma or family history of medullary thyroid carcinoma or MEN 2 syndrome
  • Decompensated heart failure (NYHA III or IV), unstable angina, or myocardial infarction within past 12 months
  • Uncontrolled hypertension with systolic over 180 mmHg or diastolic over 110 mmHg
  • Use of medications for alcohol use disorder within 28 days prior to inclusion
  • Use of investigational drugs or other weight-lowering medications within past 3 months
  • Hypersensitivity to tirzepatide or excipients
  • Inability to speak or understand Danish
  • Any other condition that may interfere with participation as judged by the investigator
  • Contraindications for MRI for participants undergoing brain scans
  • Intermittent benzodiazepine use within 12 days before brain scans (regular stable dose allowed)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Department of Psychiatry, Aalborg University Hospital

Aalborg, Denmark, Denmark, 9000

Actively Recruiting

2

Psychiatric Center Copenhagen, Frederiksberg Hospital

Frederiksberg, Denmark, Denmark, 2100

Actively Recruiting

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Research Team

S

Søren B Jensen, MD

CONTACT

A

Anders Fink-Jensen, MD, DMSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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