NCT06939088 Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder
| NCT ID | NCT06939088 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anders Fink-Jensen, MD, DMSci |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 108 participants in total. It began in 2025-05-05 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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 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.
Contact & Investigator
Anders Fink-Jensen, MD, DMSc, Professor
PRINCIPAL INVESTIGATOR
Mental Healt h Service Centre Copenhagen , Frederiksberg Hospital, NP Lab
Frequently Asked Questions
Who can join the NCT06939088 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06939088 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06939088 currently recruiting?
Yes, NCT06939088 is actively recruiting participants. Contact the research team at soeren.broegger.jensen@regionh.dk for enrollment information.
Where is the NCT06939088 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Frederiksberg, Denmark.
Who is sponsoring the NCT06939088 clinical trial?
NCT06939088 is sponsored by Anders Fink-Jensen, MD, DMSci. The principal investigator is Anders Fink-Jensen, MD, DMSc, Professor at Mental Healt h Service Centre Copenhagen , Frederiksberg Hospital, NP Lab. The trial plans to enroll 108 participants.