DUALPSYCHIATRY

RecruitingPhase 2

Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

Effect of Tirzepatide on Alcohol Intake and Reward Processing in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

Lead sponsor

Anders Fink-Jensen, MD, DMSci

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

108

estimated

Study population

Alcohol / substance use, Psychiatric (schizophrenia / bipolar / depression)

Key I/E criterion

—

Primary endpoint

•Alcohol consumption, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06939088

Org study IDThe DUALPSYCHIATRY study

Secondary ID2024-518608-28-00EU CT NUMBER

Secondary IDU1111-1312-8134Universal Trial Number

Timeline

Milestones

Study first posted2025-04-22actual

Study start2025-05-05actual

Last update posted2026-02-10actual

Primary completion2028-08-01estimated

Study completion2028-12-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Alcohol / substance usePsychiatric (schizophrenia / bipolar / depression)

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

Other (unclassified)

Weight & body composition

MASH / liver

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Body weight

Time frame:From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:From baseline to 16 and 26 weeks of treatment

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Glycaemic control parameters

Time frame:From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints

Secondary/protocol endpoint

Blood parameters

Time frame:From baseline to 16 and 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Liver fibrosis (FIB-4 score)

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Blood pressure

Time frame:From baseline to 16 and 26 weeks of treatment

change from baseline, improvement

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

The Patient Health Questionnaire (PHQ-9)

Time frame:From baseline to 16 and 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

WHO-5 Subjective Well-Being Index

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Global Assessment of Psychosocial Disability (GAPD)

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Clinical Global Impression Severity Scale (CGI-S)

Time frame:From baseline to 26 weeks of treatment

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Qualitative experience

Time frame:From baseline to 16 weeks of treatment

descriptive

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint/low confidence

Safety Outcome

Time frame:From baseline to 16 and 26 weeks of treatment

descriptive, event

Other clinical outcomes

15 endpoints

Primary/protocol endpoint

Change in heavy drinking days

Time frame:From baseline to 16 weeks of treatment

Alcohol consumption, change

percent change from baseline, improvement

Secondary/protocol endpoint

Heavy drinking days

Time frame:From baseline to 26 weeks of treatment and 14 weeks post-intervention

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Total alcohol consumption

Time frame:From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Days without alcohol consumption

Time frame:From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

World Health Organization (WHO) Risk Levels of Alcohol Consumption

Time frame:From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Penn Alcohol Craving Scale (PACS) score

Time frame:From baseline to 16 and 26 weeks of treatment

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Alcohol Use Disorder Identification Test (AUDIT) score

Time frame:From baseline to 16 and 26 weeks of treatment

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Drug Use Disorders Identification Test (DUDIT) score

Time frame:From baseline to 16 and 26 weeks of treatment

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Drug use frequency

Time frame:From baseline to 16 and 26 weeks of treatment

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Preferred substance of use

Time frame:From baseline to 16 and 26 weeks of treatment

categorical status, improvement

Secondary/protocol endpoint/low confidence

Biomarkers of cannabis exposure

Time frame:From baseline to 16 and 26 weeks of treatment

change from baseline, descriptive

components11-OH-THC level, THCCOOH level

Secondary/protocol endpoint

Fagerströms Test for Nicotine Dependence score

Time frame:From baseline to 16 and 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of cigarettes smoked per day

Time frame:From baseline to 16 and 26 weeks of treatment

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

fMRI alcohol cue-reactivity

Time frame:From baseline to 16 weeks of treatment

change from baseline, descriptive

Secondary/protocol endpoint

Positive and Negative Syndrome Scale (PANSS-6)

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Cotinine levels

Time frame:From baseline to 16 and 26 weeks of treatment

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Blood phosphatidyl ethanol (PEth) levels

Time frame:From baseline to 16 and 26 weeks of treatment and 14 weeks post-intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proteomics

Time frame:From baseline to 16 and 26 weeks of treatment

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.