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HomeTrials › NCT07218354

Other · Phase 3 · Opening soon

Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of a GLP-1 Receptor Agonist Semaglutide in U.S. Veterans With Alcohol Use Disorder

NCT07218354 · Sponsor: VA Office of Research and Development

What this trial means for you

This study is opening soon at 19 US sites. It's studying Semaglutide, Placebo for alcohol use disorder.

Who can joinAll sexes, 18 Years – 80 Years
Healthy volunteersAccepted
What you'd takeSemaglutide, Placebo
Study length~21 months overall
Planned participants622
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 28-week period, followed by a 4-week post-treatment safety assessment period. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 mg per week, depending on their tolerance. The primary measure of success will be a reduction in risky drinking, assessed through a reliable calendar-based interview method called the Timeline Follow-Back (TLFB), a well-validated calendar-based interview technique for recording daily alcohol consumption. The purpose of this research is to gather information on the effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: * Veteran. * WHO risk drinking level of Very High or High in the 28 days prior to screening. * Current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria) based on semi-structured diagnostic exam. * Able and willing to provide informed consent. * Has a desire to reduce their alcohol consumption. Exclusion Criteria: Medical and Psychiatric: * Type 1 diabetes. * 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 SUD (other than moderate-to-severe alcohol, any nicotine, or mild cannabis use disorders). * At the time of randomization, moderate-to-severe alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol (CIWA-AR) \>8). * BMI \<21 kg/m2. * Unstable body weight defined as \>5% change in body weight (documented or self-report; intentional or not) in the 90 days prior to randomization. * 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 stage 3 fibrosis or stage 4 cirrhosis from a liver biopsy. * Presence of gastroparesis. * History of acute gallbladder disease in the prior 6 months. * 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 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. * History of autoimmune liver disease. * History of hemochromatosis. * History of Wilson's disease. * History of alpha1 antitrypsin deficiency related liver disease. * Current drug-induced liver disease. * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). * Acute high risk of suicide requiring hospitalization at the time of screening or randomization. * Medical, psychiatric, behavioral, or logistical conditions which, in the judgement 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 * 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. Laboratory * Hemoglobin A1c (HbA1c)\>10. * Estimated glomerular filtration rate (eGFR) \<30 mL/min. * Albumin \< 3.5 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/µL 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. Concurrent Treatments: * Current (within the past 30 days) use of pharmacotherapy for AUD (including oral or intramuscular naltrexone, acamprosate, disulfiram, topiramate). * Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue. * 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). Other * 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. * Participant is incarcerated.

Study sites by state

California

  • VA Long Beach Healthcare System, Long Beach, CA, Long Beach
  • VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles

Florida

  • Orlando VA Healthcare System, Orlando, FL, Orlando

Georgia

  • Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur

Illinois

  • Edward Hines Jr. VA Hospital, Hines, IL, Hines

Michigan

  • VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor

Minnesota

  • Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis

North Carolina

  • Asheville VA Medical Center, Asheville, NC, Asheville
  • Durham VA Medical Center, Durham, NC, Durham

Ohio

  • Louis Stokes VA Medical Center, Cleveland, OH, Cleveland

Oregon

  • VA Portland Health Care System, Portland, OR, Portland

Pennsylvania

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia
  • Philadelphia MultiService Center, Philadelphia, PA, Philadelphia

Texas

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas
  • Michael E. DeBakey VA Medical Center, Houston, TX, Houston

Utah

  • VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City

Washington

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle

Wisconsin

  • William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently, so always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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