[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609728":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":396,"collaborators":24,"id":398,"slug":399,"hasResults":400,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":406,"sex":407,"minAge":408,"maxAge":409,"enrollmentInfo":410,"targetDuration":24,"studyType":413,"phases":414,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide","EXPERIMENTAL","Weekly subcutaneous injections of semaglutide up to 2.4 mg\u002Fweek or maximum tolerated dose. Initial dosing starting at 0.25 for weeks 1-4. Further titration up to 2.4 mg weekly starting at week 5.",[13],"Drug: Semaglutide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Weekly subcutaneous injections of placebo mimicking treatment procedure.",[19],"Drug: Placebo",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"affiliation":30,"role":31},"David W. Oslin, MD","Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA","STUDY_CHAIR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"David W Oslin, MD","CONTACT","(215) 823-5894","Dave.Oslin@va.gov",{"name":39,"role":35,"phone":24,"phoneExt":24,"email":40},"Neil C Johnson, MA BA","neil.johnson@va.gov",[42,67,87,105,125,146,166,185,203,222,238,255,275,287,302,321,339,357,376],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"VA Long Beach Healthcare System, Long Beach, CA","RECRUITING","Long Beach","California","90822","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-118.18923,33.76696,{"lat":54,"lon":53},[57,62],{"name":58,"role":35,"phone":59,"phoneExt":60,"email":61},"Larry Albers, MD","562-826-8000","12150","larry.albers@va.gov",{"name":63,"role":35,"phone":64,"phoneExt":65,"email":66},"Sakineh 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Ramic, MD","708-202-8387","22974","alma.ramic2@va.gov",{"name":163,"role":35,"phone":164,"phoneExt":24,"email":165},"Laurica Petrella-Zitko, BS","7089730757","laurica.petrella-zitko@va.gov",{"facility":167,"status":107,"city":168,"state":169,"zip":170,"country":48,"countryCode":49,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"VA Ann Arbor Healthcare System, Ann Arbor, MI","Ann Arbor","Michigan","48105-2303",{"type":51,"coordinates":172},[173,174],-83.74088,42.27756,{"lat":174,"lon":173},[177,181],{"name":178,"role":35,"phone":179,"phoneExt":24,"email":180},"Ponni Perumalswami, MD","734-845-5345","ponni.perumalswami@va.gov",{"name":182,"role":35,"phone":183,"phoneExt":24,"email":184},"Andrea Birkhofer, MPH","7344506026","andrea.birkhofer@va.gov",{"facility":186,"status":44,"city":187,"state":188,"zip":189,"country":48,"countryCode":49,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Minneapolis VA Health Care System, Minneapolis, MN","Minneapolis","Minnesota","55417-2309",{"type":51,"coordinates":191},[192,193],-93.26384,44.97997,{"lat":193,"lon":192},[196,199],{"name":197,"role":35,"phone":24,"phoneExt":24,"email":198},"Eric Dieperink, MD","Eric.Dieperink@va.gov",{"name":200,"role":35,"phone":201,"phoneExt":24,"email":202},"Sara Kemmer","6124671580","Sara.kemmer@va.gov",{"facility":204,"status":44,"city":205,"state":206,"zip":207,"country":48,"countryCode":49,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Asheville VA Medical Center, Asheville, NC","Asheville","North Carolina","28805-2576",{"type":51,"coordinates":209},[210,211],-82.55402,35.60095,{"lat":211,"lon":210},[214,217],{"name":215,"role":35,"phone":24,"phoneExt":24,"email":216},"Brandon Corbett, MD","brandon.corbett@va.gov",{"name":218,"role":35,"phone":219,"phoneExt":220,"email":221},"Kathy 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Zahl","5032208262","55474","Lorrinda.Zahl@va.gov",{"facility":30,"status":44,"city":276,"state":277,"zip":278,"country":48,"countryCode":49,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Philadelphia","Pennsylvania","19104-4551",{"type":51,"coordinates":280},[281,282],-75.16362,39.95238,{"lat":282,"lon":281},[285,286],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},{"name":29,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":288,"status":107,"city":276,"state":277,"zip":289,"country":48,"countryCode":49,"cosmosGeoPoint":290,"geoPoint":292,"contacts":293},"Corporal Michael J. Crescenz VA Medical Center","19104",{"type":51,"coordinates":291},[281,282],{"lat":282,"lon":281},[294,297],{"name":295,"role":35,"phone":24,"phoneExt":24,"email":296},"Kyle Kampman, MD","kyle.kampman@va.gov",{"name":298,"role":35,"phone":299,"phoneExt":300,"email":301},"Christen Holmes","2158235800","203404","christen.holmes@va.gov",{"facility":303,"status":44,"city":304,"state":305,"zip":306,"country":48,"countryCode":49,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX","Dallas","Texas","75216-7167",{"type":51,"coordinates":308},[309,310],-96.80667,32.78306,{"lat":310,"lon":309},[313,317],{"name":314,"role":35,"phone":315,"phoneExt":24,"email":316},"Kyaw Soe, MD","214-857-0125","kyaw.soe@va.gov",{"name":318,"role":35,"phone":319,"phoneExt":24,"email":320},"Jodie-Ann Clarke","2148570393","jodie-ann.clarke@va.gov",{"facility":322,"status":107,"city":323,"state":305,"zip":324,"country":48,"countryCode":49,"cosmosGeoPoint":325,"geoPoint":329,"contacts":330},"Michael E. DeBakey VA Medical Center, Houston, TX","Houston","77030-4211",{"type":51,"coordinates":326},[327,328],-95.36327,29.76328,{"lat":328,"lon":327},[331,335],{"name":332,"role":35,"phone":333,"phoneExt":24,"email":334},"Christopher Verrico, PhD","713-798-7658","Christopher.verrico@va.gov",{"name":336,"role":35,"phone":337,"phoneExt":24,"email":338},"Adetola Vaughan, MPH","8327794803","adetola.vaughan@bcm.edu",{"facility":340,"status":107,"city":341,"state":342,"zip":343,"country":48,"countryCode":49,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"VA Salt Lake City Health Care System, Salt Lake City, UT","Salt Lake City","Utah","84148-0001",{"type":51,"coordinates":345},[346,347],-111.89105,40.76078,{"lat":347,"lon":346},[350,354],{"name":351,"role":35,"phone":352,"phoneExt":24,"email":353},"Adam Gordon, MD","385-297-0370","adam.gordon@va.gov",{"name":355,"role":35,"phone":24,"phoneExt":24,"email":356},"Dianna Fuessel-Herrmann","Dianna.Fuesselherrmann@va.gov",{"facility":358,"status":44,"city":359,"state":360,"zip":361,"country":48,"countryCode":49,"cosmosGeoPoint":362,"geoPoint":366,"contacts":367},"VA Puget Sound HCS - Seattle and Tacoma","Tacoma","Washington","98493",{"type":51,"coordinates":363},[364,365],-122.44429,47.25288,{"lat":365,"lon":364},[368,372],{"name":369,"role":35,"phone":370,"phoneExt":24,"email":371},"SueAnn Brickle","253-583-2026","sueann.brickle@va.gov",{"name":373,"role":35,"phone":374,"phoneExt":24,"email":375},"Deepika Agrawal, MD","2535832026","deepika.agrawal@va.gov",{"facility":377,"status":107,"city":378,"state":379,"zip":380,"country":48,"countryCode":49,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"William S. Middleton Memorial Veterans Hospital, Madison, WI","Madison","Wisconsin","53705-2254",{"type":51,"coordinates":382},[383,384],-89.40123,43.07305,{"lat":384,"lon":383},[387,391],{"name":388,"role":35,"phone":389,"phoneExt":24,"email":390},"Timothy Juergens, MD","608-280-7084","Timothy.juergens@va.gov",{"name":392,"role":35,"phone":393,"phoneExt":394,"email":395},"Nicole Rafidi, MS","6082561901","11405","nicole.rafidi@va.gov",{"type":397,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100609728","phase-3-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-us-veterans-with-alcohol-use-disorder-100609728",false,"NCT07218354","Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE)","CSP #2041 - 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 (CRAVE)","CRAVE","Inclusion Criteria:\n\n* Veteran\n* WHO risk drinking level of Very High or High in the 28 days prior to screening (based on screening TLFB)\n* 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 (MINI)\n* Able and willing to provide informed consent\n* Has a desire to reduce their alcohol consumption\n\nExclusion Criteria:\n\n* Medical History (medical history form)\n\n  * Type 1 diabetes\n  * History of acute or chronic pancreatitis\n  * History of diabetic ketoacidosis\n  * History of proliferative diabetic retinopathy\n  * History of ascites, advanced liver fibrosis, compensated cirrhosis with portal hypertension, decompensated cirrhosis, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or hepatocellular carcinoma (HCC)\n  * 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\n  * History of stage 3 fibrosis or stage 4 cirrhosis from a liver biopsy\n  * History of esophageal varices on endoscopy or imaging\n  * History of nodular liver, cirrhosis, splenomegaly, varices or splenic venous shunting or collaterals on prior imaging\n  * History or acute alcohol hepatitis (by liver biopsy or elevated bilirubin \\> 1.5 times the upper limit of normal)\n  * History of primary biliary cholangitis\n  * History of primary sclerosing cholangitis\n  * Current drug-induced liver disease\n  * History of alpha1 antitrypsin deficiency related liver disease\n  * History of autoimmune liver disease\n  * History of hemochromatosis\n  * History of Wilson's disease\n  * Presence of gastroparesis\n  * History of acute gallbladder disease in the prior 6 months\n  * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)\n  * Unstable body weight defined as \\>5% change in body weight (documented or self-report; intentional or not) in the 90 days prior to randomization\n  * 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\n  * Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue\n* Concurrent Treatments (medical history form):\n\n  * Current (within the past 30 days) use of pharmacotherapy for AUD (including oral or intramuscular naltrexone, acamprosate, disulfiram, topiramate)\n  * 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\n  * Recent changes in dose (within 2 months of randomization) of psychiatric medications (i.e., antidepressants, antianxiety, mood stabilizing)\n* Psychiatric diagnosis (MINI)\n\n  * Current serious psychiatric illness (any psychotic disorder, bipolar 1 disorder, psychotic major depression, antisocial personality disorder, bulimia, or anorexia)\n  * Current DSM-5 diagnosis of a SUD (other than moderate-to-severe alcohol, any nicotine, or mild cannabis use disorders)\n* Other assessments (local site)\n\n  * At the time of randomization, moderate-to-severe alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol (CIWA-AR) \\>8)\n  * BMI \\\u003C21 kg\u002Fm2\n  * Acute high risk of suicide requiring hospitalization at the time of screening or randomization\n  * 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\n  * Pregnant, actively breastfeeding, or female of childbearing potential who is unwilling to use a highly effective method of contraception as defined by the NIH\n  * Currently enrolled in another therapeutic or investigational clinical trial without a preexisting dual enrollment agreement\n  * Participant is incarcerated\n* Laboratory\n\n  * Hemoglobin A1c (HbA1c)\\>10\n  * Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n  * Albumin \\\u003C 3.5 g\u002Fdl\n  * Aspartate aminotransferase (AST) \\>3 the Upper Limit of Normal (ULN)\n  * Alanine aminotransferase (ALT) \\>3 the ULN\n  * Lipase \\> 2 times the upper limit of normal\n  * Alkaline phosphatase \\> 1.5 times the ULN\n  * Total bilirubin \\> 1.5 times the ULN except with documented Gilbert's syndrome\n  * International Normalized Ratio (INR) \\> 1.3 unless due to anticoagulation therapy\n  * Platelet count \\\u003C150,000\u002F L unless consistent with baseline and reflects the participant's habitual thrombocyte level, and there was no presence of portal hypertension\n  * Hepatitis B surface antigen positive\n  * Hepatitis C virus RNA positive - participants treated and cured of hepatitis C must have at least 2 years of negative testing\n  * Anti-HIV antibody positive test with uncontrolled or unstable treatment\n  * Positive urine drug screen for substances other than cannabis and prescribed medications\n  * Positive urine pregnancy test at screening in those considered of childbearing potential",true,"ALL","18 Years","80 Years",{"count":411,"type":412},622,"ESTIMATED","INTERVENTIONAL",[415],"PHASE3","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 24-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 milligrams (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 safety and effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.",[418],"Alcohol Use Disorder",[418,9,420,421],"Alcohol","GLP-1","2026-08-11",{"date":424,"type":425},"2026-08-12","ACTUAL",{"date":427,"type":425},"2026-07-28",{"date":429,"type":412},"2030-03-30",{"name":5,"class":6},19]