Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use… (NCT06939088) | Clinical Trial Compass
RecruitingPhase 2
Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder
Denmark108 participantsStarted 2025-05-05
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Informed Consent: The patient must provide both oral and written informed consent.
* Diagnosis:
* Diagnosed with alcohol dependence according to the International Classification of Diseases, 10th Edition (ICD-10), and alcohol use disorder as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
* Diagnosed with schizophrenia spectrum disorder according to ICD-10 and DSM-5
* AUDIT Score: Alcohol Use Disorder Identification Test (AUDIT) score greater than 15.
* Body Mass Index (BMI): BMI of 23 kg/m² or higher.
* Age Range: Between 18 and 70 years old (inclusive).
* Heavy Alcohol Consumption: Defined as 4 or more heavy drinking days within a consecutive 21-day period during the 28 days preceding the baseline evaluation. The 21-day period will be selected based on the largest total alcohol consumption and the greatest number of heavy drinking days within the 28-day timeframe. This will be assessed using the Timeline Followback (TLFB) method. Heavy drinking days are defined as days with an alcohol intake of 4 or more units (48 g of alcohol) for women and 5 or more units (60 g of alcohol) for men.
Exclusion Criteria:
* Intellectual Disability: individuals with a diagnosis of intellectual disability.
* Acute Psychosis: Acute exacerbation of psychosis, as indicated by a score of 6 or 7 on the Clinical Global Impression-Severity (CGI-S) scale.
* Coercive Measures: Current use of coercive measures, which includes individuals…