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.
Parallel
Tirzepatide
DrugOnce weekly injections s.c. with tirzepatide (Mounjaro(R))
Placebo
DrugOnce weekly injections s.c. with placebo (BD Posiflush)
Change in heavy drinking days
The primary endpoint will be a change in alcohol consumption, measured as a per cent change in heavy drinking days after 16 weeks of treatment with tirzepatide or placebo, adjusted for the value at baseline (percentage points). Heavy drinking days will be registered using the Timeline-Follow-Back (TLFB) method including the last 21 consecutive days with the largest total alcohol intake and the greatest number of heavy drinking days within the 28 days preceding the evaluation. A heavy drinking day is defined as more than 60/48 grams (men/women) of alcohol in one day.
Heavy drinking days
Change in heavy drinking days measured using the TLFB method.
Total alcohol consumption
Change in total alcohol consumption measured using the TLFB method.
Days without alcohol consumption
Change in number of days without alcohol measured using the TLFB method.
World Health Organization (WHO) Risk Levels of Alcohol Consumption
Change in WHO alcohol risk level measured using the TLFB method.
Safety Outcome
Suicidal ideation measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
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Anders Fink-Jensen, MD, DMSci
Lead sponsor
Psychiatric Centre Rigshospitalet
Sponsor institution
