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Could a diabetes drug curb alcohol cravings in schizophrenia?

NCT ID NCT06939088

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether tirzepatide, a drug used for diabetes and obesity, can help people with both schizophrenia and alcohol use disorder drink less. Researchers will give weekly injections of tirzepatide or a placebo to 108 participants for 16 weeks, tracking heavy drinking days and brain activity. The goal is to see if this drug reduces alcohol intake and cravings in a group that badly needs better treatment options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirzepatide (Mounjaro)
What this could lead to
If it works, this could point toward a new treatment option for alcohol use disorder in people with schizophrenia, a group with few effective therapies.
What could go wrong
This is an early Phase 2 trial with only 108 participants. The results may not apply to everyone, and tirzepatide's effects on alcohol craving are still unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcohol dependence psychotic disorder schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Psychiatry, Aalborg University Hospital

    RECRUITING

    Aalborg, Denmark, 9000, Denmark

  • Psychiatric Center Copenhagen, Frederiksberg Hospital

    RECRUITING

    Frederiksberg, Denmark, 2100, Denmark

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