Diabetes drug shows promise to curb alcohol cravings in veterans
NCT ID NCT07218354
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 10 times
Summary
This study tests if semaglutide, a drug used for diabetes, can help veterans with alcohol use disorder drink less. About 622 veterans will get either the drug or a placebo shot for 28 weeks. The goal is to see if it safely reduces heavy drinking and improves health.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 622 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Veteran * World Health Organization's (WHO) risk drinking level of Very High or High in the 28 days prior to screening (based on screening TLFB) * Current diagnosis of moderate or severe alcohol use disorder (AUD), i.e., meeting at least 4 of 11 DSM-5 AUD criteria, based on semi-structured diagnostic exam, the Mini-International Neuropsychiatric Interview (MINI) * Able and willing to provide informed consent * Has a desire to reduce their alcohol consumption Exclusion Criteria: * Medical History (medical history form) * Type 1 diabetes * History of acute or chronic pancreatitis * History of diabetic ketoacidosis * History of proliferative diabetic retinopathy * History of ascites, advanced liver fibrosis, compensated cirrhosis with portal hypertension, decompensated cirrhosis, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or hepatocellular carcinoma (HCC) * History of advanced fibrosis or cirrhosis, including (but not limited to) transient elastography (liver stiffness) of \>12 kPa, FIB-4 ≥2.67, ELF ≥9.8, MRE ≥3.63 kPa * History of stage 3 fibrosis or stage 4 cirrhosis from a liver biopsy * History of esophageal varices on endoscopy or imaging * History of nodular liver, cirrhosis, splenomegaly, varices or splenic venous shunting or collaterals on prior imaging * History or acute alcohol hepatitis (by liver biopsy or elevated bilirubin \> 1.5 times the upper limit of normal) * History of primary biliary cholangitis * History of primary sclerosing cholangitis * Current drug-induced liver disease * History of alpha1 antitrypsin deficiency related liver disease * History of autoimmune liver disease * History of hemochromatosis * History of Wilson's disease * Presence of gastroparesis * History of acute gallbladder disease in the prior 6 months * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) * Unstable body weight defined as \>5% change in body weight (documented or self-report; intentional or not) in the 90 days prior to randomization * Recent major cardiovascular event in the 90 days prior to randomization (myocardial infarction, stroke, New York Heart Association class IV heart failure, transient ischemic attack (TIA), or unstable angina * Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue * Concurrent Treatments (medical history form): * Current (within the past 30 days) use of pharmacotherapy for alcohol use disorder (AUD), including oral or intramuscular naltrexone, acamprosate, disulfiram, topiramate * Current (within the past 30 days) use of the following medications with glucose-lowering properties: GLP-1 analogues; sulfonylurea; insulin and insulin products; dipeptidyl peptidase-4 (DPP-4) inhibitors; sodium-glucose cotransporter-2 (SGLT-2) inhibitors, meglitinides, thiazolidinediones or other medications that may interact with semaglutide * Recent changes in dose (within 2 months of randomization) of psychiatric medications (i.e., antidepressants, antianxiety, mood stabilizing) * Psychiatric diagnosis, the Mini-International Neuropsychiatric Interview (MINI) * Current serious psychiatric illness (any psychotic disorder, bipolar 1 disorder, psychotic major depression, antisocial personality disorder, bulimia, or anorexia) * Current DSM-5 diagnosis of a Substance use disorder (SUD), other than moderate-to-severe alcohol, any nicotine, or mild cannabis use disorders * Other assessments (local site) * At the time of randomization, moderate-to-severe alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol (CIWA-AR) \>8) * Body mass index (BMI) \<21 kilograms/square meter (kg/m2) * Acute high risk of suicide requiring hospitalization at the time of screening or randomization * Medical, psychiatric, behavioral, or logistical conditions which, in the judgment of the Local Site Investigator (LSI) or Co-Investigator (Co-I), make it unlikely the participant can participate in or complete the 24-week active phase of the study * Pregnant, actively breastfeeding, or female of childbearing potential who is unwilling to use a highly effective method of contraception as defined by the NIH * Currently enrolled in another therapeutic or investigational clinical trial without a preexisting dual enrollment agreement * Participant is incarcerated * Laboratory * Hemoglobin A1c (HbA1c)\>10 * Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute (mL/min) * Albumin \< 3.5 grams/deciliter (g/dl) * Aspartate aminotransferase (AST) \>3 the Upper Limit of Normal (ULN) * Alanine aminotransferase (ALT) \>3 the ULN * Lipase \> 2 times the upper limit of normal * Alkaline phosphatase \> 1.5 times the ULN * Total bilirubin \> 1.5 times the ULN except with documented Gilbert's syndrome * International Normalized Ratio (INR) \> 1.3 unless due to anticoagulation therapy * Platelet count \<150,000/ liter (L) unless consistent with baseline and reflects the participant's habitual thrombocyte level, and there was no presence of portal hypertension * Hepatitis B surface antigen positive * Hepatitis C virus RNA positive - participants treated and cured of hepatitis C must have at least 2 years of negative testing * Anti-HIV antibody positive test with uncontrolled or unstable treatment * Positive urine drug screen for substances other than cannabis and prescribed medications * Positive urine pregnancy test at screening in those considered of childbearing potential
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Conditions
The condition(s) this trial relates to.
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.
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The places running it
19 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Asheville VA Medical Center, Asheville, NC
RECRUITINGAsheville, North Carolina, 28805-2576, United States
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Atlanta VA Medical and Rehab Center, Decatur, GA
NOT_YET_RECRUITINGDecatur, Georgia, 30033-4004, United States
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Corporal Michael J. Crescenz VA Medical Center
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
RECRUITINGPhiladelphia, Pennsylvania, 19104-4551, United States
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Durham VA Medical Center, Durham, NC
RECRUITINGDurham, North Carolina, 27705-3875, United States
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Edward Hines Jr. VA Hospital, Hines, IL
RECRUITINGHines, Illinois, 60141-3030, United States
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Louis Stokes VA Medical Center, Cleveland, OH
RECRUITINGCleveland, Ohio, 44106-1702, United States
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Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITINGHouston, Texas, 77030-4211, United States
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Minneapolis VA Health Care System, Minneapolis, MN
RECRUITINGMinneapolis, Minnesota, 55417-2309, United States
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Orlando VA Healthcare System, Orlando, FL
RECRUITINGOrlando, Florida, 32827, United States
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VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITINGAnn Arbor, Michigan, 48105-2303, United States
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VA Greater Los Angeles Healthcare System, West Los Angeles, CA
RECRUITINGWest Los Angeles, California, 90073-1003, United States
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VA Long Beach Healthcare System, Long Beach, CA
RECRUITINGLong Beach, California, 90822, United States
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VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
RECRUITINGDallas, Texas, 75216-7167, United States
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VA Palo Alto Health Care System, Palo Alto, CA
RECRUITINGPalo Alto, California, 94304-1207, United States
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VA Portland Health Care System, Portland, OR
RECRUITINGPortland, Oregon, 97207-2964, United States
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VA Puget Sound HCS - Seattle and Tacoma
RECRUITINGTacoma, Washington, 98493, United States
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VA Salt Lake City Health Care System, Salt Lake City, UT
RECRUITINGSalt Lake City, Utah, 84148-0001, United States
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William S. Middleton Memorial Veterans Hospital, Madison, WI
RECRUITINGMadison, Wisconsin, 53705-2254, United States
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