Effect of Tirzepatide on Alcohol Intake and Reward Processing in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder
New trial tests if Tirzepatide can help schizophrenia patients reduce alcohol use.
Plain English Summary
Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder is a Phase 2 clinical trial sponsored by Anders Fink-Jensen, MD, DMSci studying Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence, Alcoholism, Schizophrenia Disorders, Schizophrenia and Disorders With Psychotic Features, Schizophrenia and Schizophrenia Spectrum Psychosis, Schizophrenia. This trial is testing if a drug called Tirzepatide can help people who have both schizophrenia and alcohol use disorder drink less alcohol. It is for adults aged 18-70 who have been diagnosed with schizophrenia and alcohol use disorder, and who drink heavily. Participants will receive weekly injections of either Tirzepatide or a placebo (a dummy drug) for 16 weeks, and will have regular check-ups and brain scans. Current treatments for alcohol use disorder in people with schizophrenia are limited, and this trial aims to find a new option. The trial aims to enroll 108 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 70 years old and have been diagnosed with both schizophrenia and alcohol use disorder. You must also have a high score on a test for alcohol use and a BMI of 23 or higher. You cannot join if you have intellectual disability, are experiencing acute psychosis, have severe suicidal behavior, or have a history of severe alcohol withdrawal. People with type 1 or 2 diabetes, certain heart or kidney problems, or a history of pancreatitis are also excluded. This trial is studying Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence, Alcoholism, Schizophrenia Disorders, Schizophrenia and Disorders With Psychotic Features, Schizophrenia and Schizophrenia Spectrum Psychosis, Schizophrenia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if Tirzepatide reduces the number of days participants drink heavily over 16 weeks, meaning it could help them control their alcohol intake. The specific primary outcome measures are: Change in heavy drinking days (From baseline to 16 weeks of treatment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial is important because it explores a new treatment for individuals with both schizophrenia and alcohol use disorder, a group with limited effective options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence, Alcoholism, Schizophrenia Disorders, Schizophrenia and Disorders With Psychotic Features, Schizophrenia and Schizophrenia Spectrum Psychosis, Schizophrenia, where improved treatment options are needed.
Investor Insight
Tirzepatide, already approved for diabetes and obesity, is being investigated for alcohol use disorder, suggesting a potential expansion into a significant market with unmet needs. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of participating in this trial. Participation involves weekly injections and regular visits for assessments, including brain scans for some participants. You will need to be able to speak and understand Danish to participate. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 108 participants
Interventions
- DRUG: Tirzepatide — Once weekly injections s.c. with tirzepatide (Mounjaro(R))
- DRUG: Placebo — Once weekly injections s.c. with placebo (BD Posiflush)
Primary Outcomes
- Change in heavy drinking days (From baseline to 16 weeks of treatment)
Secondary Outcomes
- Heavy drinking days (From baseline to 26 weeks of treatment and 14 weeks post-intervention)
- Total alcohol consumption (From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention)
- Days without alcohol consumption (From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention)
- World Health Organization (WHO) Risk Levels of Alcohol Consumption (From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention)
- Penn Alcohol Craving Scale (PACS) score (From baseline to 16 and 26 weeks of treatment)
Full 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.Trial Locations
- Department of Psychiatry, Aalborg University Hospital, Aalborg, Denmark, Denmark
- Psychiatric Center Copenhagen, Frederiksberg Hospital, Frederiksberg, Denmark, Denmark
Frequently Asked Questions
What is clinical trial NCT06939088?
NCT06939088 is a Phase 2 INTERVENTIONAL study titled "Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder." It is currently recruiting and is sponsored by Anders Fink-Jensen, MD, DMSci. The trial targets enrollment of 108 participants.
What conditions does NCT06939088 study?
This trial investigates treatments for Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence, Alcoholism, Schizophrenia Disorders, Schizophrenia and Disorders With Psychotic Features, Schizophrenia and Schizophrenia Spectrum Psychosis, Schizophrenia. The primary condition under study is Alcohol Use Disorder.
What treatments are being tested in NCT06939088?
The interventions being studied include: Tirzepatide (DRUG), Placebo (DRUG). Once weekly injections s.c. with tirzepatide (Mounjaro(R))
What does Phase 2 mean for NCT06939088?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06939088?
This trial is currently "Recruiting." It started on 2025-05-05. The estimated completion date is 2028-12-31.
Who is sponsoring NCT06939088?
NCT06939088 is sponsored by Anders Fink-Jensen, MD, DMSci. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06939088?
The trial aims to enroll 108 participants. The trial is currently recruiting and accepting new participants.
How is NCT06939088 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06939088?
The primary outcome measures are: Change in heavy drinking days (From baseline to 16 weeks of treatment). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06939088 being conducted?
This trial is being conducted at 2 sites, including Aalborg, Denmark; Frederiksberg, Denmark (Denmark).
Where can I find official information about NCT06939088?
The official record for NCT06939088 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06939088. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06939088 testing in simple terms?
This trial is testing if a drug called Tirzepatide can help people who have both schizophrenia and alcohol use disorder drink less alcohol. It is for adults aged 18-70 who have been diagnosed with schizophrenia and alcohol use disorder, and who drink heavily.
Why is this trial significant?
This trial is important because it explores a new treatment for individuals with both schizophrenia and alcohol use disorder, a group with limited effective options.
What are the potential risks of participating in NCT06939088?
Common side effects of Tirzepatide can include nausea, vomiting, diarrhea, and constipation. There is a risk of more serious side effects like pancreatitis, gallbladder problems, or low blood sugar, especially in people with diabetes (though people with diabetes are excluded from this trial). Brain scans may have risks related to claustrophobia or metal implants. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06939088?
Ask your doctor about the potential benefits and risks of participating in this trial. Participation involves weekly injections and regular visits for assessments, including brain scans for some participants. You will need to be able to speak and understand Danish to participate. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06939088 signal from an investment perspective?
Tirzepatide, already approved for diabetes and obesity, is being investigated for alcohol use disorder, suggesting a potential expansion into a significant market with unmet needs. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive weekly injections of either Tirzepatide or a placebo (a dummy drug) for 16 weeks, and will have regular check-ups and brain scans. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.