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Huhn, Ph.D.","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Andrew S Huhn, Ph.D.","CONTACT","410-550-1971","ahuhn1@jhu.edu",{"name":48,"role":44,"phone":28,"phoneExt":28,"email":49},"Breanna Labos, B.A.","blabos1@jhmi.edu",[51],{"facility":52,"status":28,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Ashley Addiction Treatment","Havre de Grace","Maryland","21078","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-76.09162,39.54928,{"lat":62,"lon":61},[65],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"type":67,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100054081","phase-2-combination-therapy-for-alcohol-use-disorder-100054081",false,"NCT07249554","Combination Therapy for Alcohol Use Disorder","Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder","Inclusion Criteria:\n\n* Aged 21-65 years old\n* Enrolled at Ashley Addiction Treatment center at least one week prior to beginning study participation.\n* Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for Alcohol Use Disorder\n* Willing to comply with the study protocol\n\nExclusion Criteria:\n\n* Score 9 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) at randomization\n* Currently pregnant, breastfeeding\n* Unwilling to use contraceptives (e.g., condoms and\u002For hormonal birth control)\n* Meet criteria for another substance use disorder other than AUD, Tobacco Use Disorder, or Caffeine use disorder\n* History of pancreatitis\n* History or current diagnosis of gallbladder disease, hepatic disease, renal disease, hyperparathyroidism, or any physical health condition that would be contraindicated with GLP-1 agonists or naltrexone.\n* Unmanaged diabetes diagnosis or history or current diagnosis of diabetic retinopathy\n* Levels of amylase, lipase, aspartate aminotransferase (AST), and\u002For alanine transferase (ALT) greater than 2x upper limit of normal\n* Personal or family history of medullary thyroid carcinoma given FDA box warning for semaglutide\n* Diagnosis of cancer within past 5 years\n* History of multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Currently taking any medications contraindicated with GLP-1 agonists and\u002For naltrexone.\n* BMI \\\u003C18.5\n* Current elevated suicide risk as assessed by clinic staff or the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Any other medical or psychological condition that is judged by the investigators to impede ability to safely complete study requirements.\n* Legal problems or living situation judged by the investigators as a factor that could interfere with study completion (e.g., impending jail time).\n* Allergies to semaglutide and\u002For naltrexone\n* Use of opioids within the past 10 days as indicated by self-report or a positive urine drug screen\n* Prescribed or taking the following medications in the past four weeks:\n* The following medications will be prohibited during study participation due to interactions with semaglutide: other GLP-1 agonists (e.g. Exenatide, liraglutide, dulaglutide), insulin, insulin-secreting medications (e.g. sulfonylureas, meglitinides), tirzepetide, dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. sitagliptin, saxagliptin, linagliptin, alogliptin, evogliptin, and gemigliptin).\n* The following medications will be prohibited during study participation due to interactions with naltrexone: bremelanotide, peripherally-acting mu-opioid receptor antagonists (e.g. methylnaltrexone, naldemedine), and opioid agonist medications.","ALL","21 Years","65 Years",{"count":79,"type":80},45,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","This human laboratory study will collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for alcohol use disorder.",[86],"Alcohol Use Disorder",[88,89,86,90],"Glucagon-like peptide 1","Naltrexone","Addiction","NOT_YET_RECRUITING","2026-07-10",{"date":94,"type":95},"2026-07-13","ACTUAL",{"date":97,"type":80},"2026-09",{"date":99,"type":80},"2028-09",{"name":5,"class":6},1]