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.
Informed Consent: The patient must provide both oral and written informed consent.
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.
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 sentenced to treatment ('dom til behandling').
Suicidal Behaviour: Evidence of current severe suicidal behaviour, as assessed by the investigator during clinical evaluation.
Anders Fink-Jensen, MD, DMSci
Lead sponsor
Psychiatric Centre Rigshospitalet
Sponsor institution