Authorised Therapeutic exploratory (Phase II) Schizophrenia and Alcohol Use Disorder

Can treatment with tirzepatide reduce alcohol intake in individuals diagnosed with schizophrenia and alcohol use disorder (DUALPSYCHIATRY)

EU CTIS ID: 2024-518608-28-00

What this study is testing

This study will examine the effects of tirzepatide vs. placebo on alcohol consumption in patients diagnosed with schizophrenia and alcohol use disorder.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Informed Consent: The patient must provide both oral and written informed consent.
  • Diagnosis: o 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). o 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.

You likely can't join if

  • - Intellectual Disability: individuals with a diagnosis of intellectual disability.
  • - 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.
See the full eligibility criteria
Who can join
  • Informed Consent: The patient must provide both oral and written informed consent.
  • Diagnosis: o 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). o 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.
What rules you out
  • - Intellectual Disability: individuals with a diagnosis of intellectual disability.
  • - 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, including tirzepatide or other GLP-1 RA, in the past three months.
  • - Allergic Reactions: Hypersensitivity to the active substance or any of the excipients.
  • - Acute Psychosis: Acute exacerbation of psychosis, Severe acute exacerbation of psychosis, as assessed by the investigator during clinical evaluation
  • - 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.
  • - 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: Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, intend to become pregnant within the next eight months (including 26 weeks of treatment plus two months after discontinuation of tirzepatide), 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.