[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558236":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":104,"collaborators":107,"id":115,"slug":42,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":42,"eligibilityCriteria":119,"healthyVolunteers":116,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":42,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":138,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational group","EXPERIMENTAL","Participants randomized to semaglutide will be started at a low dose (0.25 mg once per week) which will be gradually increased weekly until 1.0 mg is reached at Week 4 of the intervention.",[13],"Drug: Semaglutide Pen Injector",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Participants in the control group will have placebo administered once per week.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Semaglutide Pen Injector","Semaglutide will be provided using an injection pen",[9],[27],"Ozempic",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Placebo will be a dry needle stick; no substances will be injected",[15],[33],"Dry needle stick",[35],{"name":36,"affiliation":5,"role":37},"Jennifer Nyland, PhD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","717-531-6172",null,"jnyland@pennstatehealth.psu.edu",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Kirsten Shuler, MSc","717-531-4104","kshuler@pennstatehealth.psu.edu",[49,68,84],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of Maryland Baltimore","RECRUITING","Baltimore","Maryland","21223","United States",{"type":57,"coordinates":58},"Point",[59,60],-76.61219,39.29038,{"lat":60,"lon":59},[63,66],{"name":64,"role":40,"phone":42,"phoneExt":42,"email":65},"Eric Weintraub","eweintra@som.umaryland.edu",{"name":67,"role":37,"phone":42,"phoneExt":42,"email":42},"Eric Weintraub, MD",{"facility":69,"status":51,"city":70,"state":70,"zip":71,"country":55,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"NYU Langone Health","New York","10016",{"type":57,"coordinates":73},[74,75],-74.00597,40.71427,{"lat":75,"lon":74},[78,82],{"name":79,"role":40,"phone":80,"phoneExt":42,"email":81},"Mat Kladney","929 573 0673","mathew.kladney@nyulangone.org",{"name":83,"role":37,"phone":42,"phoneExt":42,"email":42},"Mathew Kladney, MD",{"facility":85,"status":51,"city":86,"state":87,"zip":88,"country":55,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Pennsylvania Psychiatric Institute","Harrisburg","Pennsylvania","17110",{"type":57,"coordinates":90},[91,92],-76.88442,40.2737,{"lat":92,"lon":91},[95,98,102],{"name":96,"role":40,"phone":42,"phoneExt":42,"email":97},"Subi Upadhyay","supadhyay1@pennstatehealth.psu.edu",{"name":99,"role":40,"phone":100,"phoneExt":42,"email":101},"Angela Spangler","(717) 683-7838","aspangler@pennstatehealth.psu.edu",{"name":103,"role":37,"phone":42,"phoneExt":42,"email":42},"Sarah Kawasaki, MD",{"type":37,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Patricia Sue Grigson","Chairperson (Academic Administrator) Neural and Behavioral Sciences",[108,110,112],{"name":109,"class":6},"New York University",{"name":111,"class":6},"University of Maryland",{"name":113,"class":114},"National Institute on Drug Abuse (NIDA)","NIH","100558236",false,"NCT06548490","GLP-1R Agonist Treatment for Opioid Use Disorder","Inclusion Criteria:\n\n* Age 18 to 75 years.\n* Body mass index (BMI) \\> 18.\n* Able and willing to provide informed consent prior to any study-related activities.\n* Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis. Patients are eligible if they have a MINI \\> 3 (\"moderate\" or \"severe\" in the \"Specify If\" box in the Substance Use Disorder (Non-Alcohol) module for the category of opiates).\n* Currently receiving outpatient treatment for OUD and at least 2 weeks on buprenorphine (BUP) or 4 weeks on methadone at the study site and\u002For at an associated clinic at the time of enrollment.\n* Have at least 1 urine test positive for opioids after 2 weeks on BUP or 4 weeks on methadone.\n* Have positive self-reporting of opioid use after 2 weeks on BUP or 4 weeks on methadone.\n* If anatomically capable of becoming pregnant and of childbearing age, is not pregnant (confirmed) or breastfeeding at the time of enrollment and agrees to use a medically accepted method of birth control or to abstain from sexual intercourse while in the study.\n* Able to read and communicate in English to the level required to accept standard care and complete all study requirements.\n* Able and willing to engage\u002Fadhere to the entirety of the study protocol (19 weeks).\n* Not currently a prisoner.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 75 years.\n* BMI \\\u003C18.\n* Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.\n* Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.\n* History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to semaglutide or another GLP-1R agonist.\n* Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome Type 2 (MEN 2) or thyroid nodule.\n* Type 1 diabetes or history of diabetic ketoacidosis.\n* Type 2 diabetes mellitus or current use of a dipeptidyl peptidase-4 (DPP-4) inhibitor.\n* Past 30-day use of Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide.\n* Hypoglycemia on intake visit (blood glucose \\\u003C 60 mg\u002FdL).\n* End-stage renal failure, on dialysis, or glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin per 1.73 square meters or previous renal transplant.\n* End stage liver disease or previous liver transplant.\n* Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal (GI) disease.\n* Current or past diagnosis of gallbladder disease or gallstones.\n* Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery disease, deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve or aortic stenosis, hypertrophic cardiomyopathy, stroke).\n* Severe co-occurring psychiatric disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia), and\u002For history or evidence of organic brain disease or dementia that would compromise safety or compliance with the study protocol in the opinion of the site principal investigator (PI) and\u002For physician. As there is no specific scale that determines this, this will include the Site PI\u002Fphysician determining if the potential participant shows consistency in decision making and if they are alert and oriented to time, date, day and location.\n* Significant risk of suicide requiring a different\u002Fhigher level of care, according to the clinical judgment of the study physician or site principal investigator, or history of suicide attempts within the past 1 year, unless participation is cleared by clinician assessment and\u002For judgment. A Columbia-Suicide Severity Rating Scale (C-SSRS) indicating a history of suicide attempts within the past year, or active suicidal ideation within the past 1 month, will qualify as significant risk of suicide.\n* Treatment with any investigational drug in the one month preceding the study.\n* Any contraindication to both methadone and BUP.\n* Any contraindication to a GLP-1R agonist.\n* Previous randomization for participation in this trial.\n* Any other condition at screening that precludes safe participation in the trial in the judgment of the site PI or study physician.\n* Plans for travel outside of the local area over the 19 weeks (1 week of baseline, 12 weeks of medication, 1 week wash-out, and follow-up after a further 28 days) that would interfere with visits during the study period or other logistic factors that would make it difficult to commit to the entire duration of study.\n* Currently a prisoner.","ALL","18 Years","75 Years",{"count":124,"type":125},200,"ESTIMATED","INTERVENTIONAL",[128],"PHASE2","The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is:\n\n• Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids?\n\nThe investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids.\n\nThe participants will:\n\n* Take semaglutide or a placebo every week for 12 weeks\n* Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires\n* Complete smartphone surveys sent at set times during the study",[131,132,133,134,135,136,137],"Opioid Use Disorder","Opioid Abuse and Addiction","Narcotic-Related Disorders","Substance-Related Disorders","Chemically-Induced Disorders","Mental Disorder","Opioid",[139,140,141,142,143],"Opiate treatment","Opioid treatment","Glucagon-Like Peptide-1 Agonist","Opioid use disorder","Semaglutide","2025-08-11",{"date":146,"type":147},"2025-08-14","ACTUAL",{"date":149,"type":147},"2025-01-13",{"date":151,"type":125},"2026-11",{"name":5,"class":6},3]