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New treatment option for Alcohol Use Disorder
Official title Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06939088
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for alcohol use disorder.
Also referred to as Mounjaro.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Diagnosed with schizophrenia spectrum disorder according to ICD-10 and DSM-5
- AUDIT Score: Alcohol Use Disorder Identification Test (AUDIT) score greater than 15.
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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)...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark, Denmark
- Frederiksberg, Denmark, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark, Denmark; Frederiksberg, Denmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.