Status:
RECRUITING
Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder
Lead Sponsor:
Anders Fink-Jensen, MD, DMSci
Conditions:
Alcohol Use Disorder
Alcohol Abuse/Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Detailed Description
The study is a randomised (1:1), double-blinded, placebo-controlled clinical trial including 26 weeks of treatment investigating whether tirzepatide vs placebo can reduce the number of heavy drinking ...
Eligibility Criteria
Inclusion
- 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
- 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.
- History of Severe Alcohol Withdrawal: History of delirium tremens or alcohol withdrawal seizures.
- Severe Withdrawal Symptoms: Clinical Institute Withdrawal Assessment of Alcohol Scale, revised (CIWA-Ar) score greater than 9 at baseline examination.
- Severe Neurological Conditions: Presence of severe neurological diseases, including severe traumatic brain injury.
- Diabetes: Type 1 or 2 diabetes
- Pregnant or Potentially Pregnant Women: WOCBP who are pregnant, breastfeeding, intend to become pregnant within the next 6 months (including 16 weeks of treatment plus two months after discontinuation of semaglutide), or are not using a highly effective contraceptive method throughout the study period. Highly effective methods include combined hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device (IUD), intrauterine system (IUS), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. WOCBP with a measured serum human chorionic gonadotropin (hCG) level greater than 3 U/L at inclusion will also be excluded.
- Liver Function: Impaired hepatic function, defined as liver transaminases greater than three times the upper limit of normal.
- Renal Function: Impaired renal function, indicated by an estimated glomerular filtration rate (eGFR) below 50 mL/min and/or plasma creatinine above 150 μmol/L.
- Pancreatic Function: History of acute or chronic pancreatitis or amylase levels more than twice the upper limit of normal.
- Thyroid Conditions: Previous medullary thyroid carcinoma (MTC) or a family history of MTC and/or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Cardiac Issues: Decompensated heart failure (NYHA class III or IV), unstable angina pectoris, or myocardial infarction within the past 12 months.
- Uncontrolled Hypertension: Systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg.
- Alcohol Use Disorder Medication: Use of medications for alcohol use disorder (e.g., disulfiram, naltrexone, acamprosate, nalmefene) within the 28 days prior to inclusion as recorded in the Timeline Followback (TLFB) schedule.
- Investigational Drugs: Receipt of any investigational drug within the past three months.
- Weight-Lowering Medications: Use of other weight-lowering pharmacotherapy in the past three months.
- Allergic Reactions: Hypersensitivity to the active substance or any of the excipients.
- Language Barriers: Inability to speak and/or understand Danish.
- Other Conditions: Any other condition that, in the investigator\'s opinion, may interfere with participation in the trial.
- For the subgroup of participants undergoing brain scans:
- MRI Contraindications: any contraindications for MRI (e.g., magnetic implants, pacemaker, claustrophobia).
- Benzodiazepine Use: Intermittent use of benzodiazepines within 12 days prior to the scanning session is not allowed. However, regular use of a stable dose of benzodiazepines is permitted.
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06939088
Start Date
May 5 2025
End Date
December 31 2028
Last Update
January 9 2026
Active Locations (2)
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1
Department of Psychiatry, Aalborg University Hospital
Aalborg, Denmark, Denmark, 9000
2
Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, Denmark, Denmark, 2100