[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06548490":3,"trial-entities:NCT06548490":272,"trial-summary:NCT06548490":275},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":25,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":54,"secondary_outcomes":81,"sex":146,"minimum_age":147,"maximum_age":148,"healthy_volunteers":149,"eligibility_criteria":150,"std_ages":189,"locations":192,"central_contacts":252,"overall_officials":261,"references":263,"see_also_links":271},"NCT06548490","STUDY00024676","GLP-1R Agonist Treatment for Opioid Use Disorder","RECRUITING","2027-04-30","2026-08","2026-08-28","2025-01-27","Milton S. Hershey Medical Center","OTHER",true,"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","The purpose of this study is to determine whether 12 weeks of once-weekly treatment with the glucagon-like peptide-1 receptor (GLP-1R) agonist, semaglutide, will reduce illicit opioid use over a 19 week period (129-172 days) among individuals in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment (i.e., medication for opioid use disorder; MOUD). Following successful consent and initiation of screening, participants will complete a baseline evaluation and begin a baseline data collection period. If screened into the study, they will be randomly assigned to semaglutide or placebo control arms, in a 1:1 ratio using a permuted-block randomization algorithm stratified by site and MOUD, and begin a 1-week baseline period. Semaglutide (injector pen) or placebo will be administered as a subcutaneously (SC) once per week for 12 weeks, starting at a dose of 0.25 mg SC and advanced on a fixed-flexible dose schedule, based on tolerability, to a dose of 1.0 mg SC per week, or the maximum tolerated dose if less than 1.0 mg. Participants will receive study intervention in an outpatient setting for a total of 12 weeks. After the 12-week intervention, participants will discontinue semaglutide or placebo and be observed for an additional week (wash-out period). A final follow-up visit will then take place approximately 4 weeks after the washout visit (calculated as 18 weeks after Baseline\u002FTreatment Visit 1).\n\nDuring each study visit, participants will undergo urine drug screening and pregnancy testing, vital signs collection, and complete mental health and drug use questionnaires. Participants will also complete smartphone surveys sent at set times during the study. Blood samples will be collected at 2 of the visits (screening and the study week 14) and a physical examination and medical history collection will be done at the baseline visit.",[18,19,20,21,22,23,24],"Opioid Use Disorder","Opioid Abuse and Addiction","Narcotic-Related Disorders","Substance-Related Disorders","Chemically-Induced Disorders","Mental Disorder","Opioid",[26,27,28,29,30],"Opiate treatment","Opioid treatment","Glucagon-Like Peptide-1 Agonist","Opioid use disorder","Semaglutide","INTERVENTIONAL","TREATMENT",[34],"PHASE2",{"count":36,"type":37},200,"ESTIMATED",[39,47],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"DRUG","Semaglutide Pen Injector","Semaglutide will be provided using an injection pen",[44],"Investigational group",[46],"Ozempic",{"type":40,"name":48,"description":49,"armGroupLabels":50,"otherNames":52},"Placebo","Placebo will be a dry needle stick; no substances will be injected",[51],"Control group",[53],"Dry needle stick",[55,59,61,63,65,67,69,71,73,75,77,79],{"measure":56,"description":57,"timeFrame":58},"Number of participants being abstinent from illicit and nonprescribed opioids.","Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit\u002Fnon-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.","Study week 2",{"measure":56,"description":57,"timeFrame":60},"Study week 3",{"measure":56,"description":57,"timeFrame":62},"Study week 4",{"measure":56,"description":57,"timeFrame":64},"Study week 5",{"measure":56,"description":57,"timeFrame":66},"Study week 6",{"measure":56,"description":57,"timeFrame":68},"Study week 7",{"measure":56,"description":57,"timeFrame":70},"Study week 8",{"measure":56,"description":57,"timeFrame":72},"Study week 9",{"measure":56,"description":57,"timeFrame":74},"Study week 10",{"measure":56,"description":57,"timeFrame":76},"Study week 11",{"measure":56,"description":57,"timeFrame":78},"Study week 12",{"measure":56,"description":57,"timeFrame":80},"Study week 13",[82,86,87,88,89,90,92,94,96,97,98,99,100,101,102,103,104,105,106,107,110,111,112,113,115,116,117,118,121,122,123,124,125,126,127,128,129,130,131,132,135,136,137,138,139,140,141,142,143,144,145],{"measure":83,"description":84,"timeFrame":85},"Self-reported opioid craving scores as assessed via smartphone surveys","Validated 0-4 scale measuring desire\u002Fintention to use drug where 0 is no desire\u002Fintention and 4 is the highest desire\u002Fintention","Study week 1",{"measure":83,"description":84,"timeFrame":58},{"measure":83,"description":84,"timeFrame":64},{"measure":83,"description":84,"timeFrame":72},{"measure":83,"description":84,"timeFrame":80},{"measure":83,"description":84,"timeFrame":91},"Study week 14",{"measure":83,"description":84,"timeFrame":93},"Study week 18",{"measure":95,"description":84,"timeFrame":58},"Self-reported opioid craving as assessed via In-person Cravings Scales scores",{"measure":95,"description":84,"timeFrame":60},{"measure":95,"description":84,"timeFrame":62},{"measure":95,"description":84,"timeFrame":64},{"measure":95,"description":84,"timeFrame":66},{"measure":95,"description":84,"timeFrame":68},{"measure":95,"description":84,"timeFrame":70},{"measure":95,"description":84,"timeFrame":72},{"measure":95,"description":84,"timeFrame":74},{"measure":95,"description":84,"timeFrame":76},{"measure":95,"description":84,"timeFrame":78},{"measure":95,"description":84,"timeFrame":80},{"measure":108,"description":109,"timeFrame":74},"Number of subjects who sustained abstinence from opioids (Binary indicator)","Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.",{"measure":108,"description":109,"timeFrame":76},{"measure":108,"description":109,"timeFrame":78},{"measure":108,"description":109,"timeFrame":80},{"measure":114,"description":109,"timeFrame":74},"Number of subjects abstinent from stimulants (i.e. cocaine or non-prescribed amphetamines) (Binary indicator)",{"measure":114,"description":109,"timeFrame":76},{"measure":114,"description":109,"timeFrame":78},{"measure":114,"description":109,"timeFrame":80},{"measure":119,"description":120,"timeFrame":58},"Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire","Validated daily binary indicator for measuring use of stimulants",{"measure":119,"description":120,"timeFrame":60},{"measure":119,"description":120,"timeFrame":62},{"measure":119,"description":120,"timeFrame":64},{"measure":119,"description":120,"timeFrame":66},{"measure":119,"description":120,"timeFrame":68},{"measure":119,"description":120,"timeFrame":70},{"measure":119,"description":120,"timeFrame":72},{"measure":119,"description":120,"timeFrame":74},{"measure":119,"description":120,"timeFrame":76},{"measure":119,"description":120,"timeFrame":78},{"measure":119,"description":120,"timeFrame":80},{"measure":133,"description":134,"timeFrame":58},"Days using opioids over the 12-week treatment period by Timeline Followback questionnaire","Validated daily binary indicator for measuring use of opioids",{"measure":133,"description":134,"timeFrame":60},{"measure":133,"description":134,"timeFrame":62},{"measure":133,"description":134,"timeFrame":64},{"measure":133,"description":134,"timeFrame":66},{"measure":133,"description":134,"timeFrame":68},{"measure":133,"description":134,"timeFrame":70},{"measure":133,"description":134,"timeFrame":72},{"measure":133,"description":134,"timeFrame":74},{"measure":133,"description":134,"timeFrame":76},{"measure":133,"description":134,"timeFrame":78},{"measure":133,"description":134,"timeFrame":80},"ALL","18 Years","75 Years",false,{"inclusion":151,"exclusion":163,"raw_text":188},[152,153,154,155,156,157,158,159,160,161,162],"Age 18 to 75 years.","Body mass index (BMI) \\> 18.","Able and willing to provide informed consent prior to any study-related activities.","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).","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.","Have at least 1 urine test positive for opioids after 2 weeks on BUP or 4 weeks on methadone.","Have positive self-reporting of opioid use after 2 weeks on BUP or 4 weeks on methadone.","If 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 or to abstain from sexual activity that could result in pregnancy (if applicable) while in the study.","Able to read and communicate in English to the level required to accept standard care and complete all study requirements.","Able and willing to engage\u002Fadhere to the entirety of the study protocol (19 weeks).","Not currently a prisoner.",[164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187],"Age \\\u003C 18 or \\> 75 years.","BMI \\\u003C18.","Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.","Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.","History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to semaglutide or another GLP-1R agonist.","Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome Type 2 (MEN 2) or thyroid nodule.","Type 1 diabetes or history of diabetic ketoacidosis.","Type 2 diabetes mellitus or current use of a dipeptidyl peptidase-4 (DPP-4) inhibitor.","Past 30-day use of Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide.","Hypoglycemia on intake visit (blood glucose \\\u003C 60 mg\u002FdL).","End-stage renal failure, on dialysis, or glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin per 1.73 square meters or previous renal transplant.","End stage liver disease or previous liver transplant.","Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal (GI) disease.","Current or past diagnosis of gallbladder disease or gallstones.","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).","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.","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.","Treatment with any investigational drug in the one month preceding the study.","Any contraindication to both methadone and BUP.","Any contraindication to a GLP-1R agonist.","Previous randomization for participation in this trial.","Any other condition at screening that precludes safe participation in the trial in the judgment of the site PI or study physician.","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.","Currently a prisoner.","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 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 or to abstain from sexual activity that could result in pregnancy (if applicable) 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.",[190,191],"ADULT","OLDER_ADULT",[193,203,220,234],{"facility":194,"status":195,"city":196,"state":197,"zip":198,"country":199,"geoPoint":200},"University of Maryland Baltimore","COMPLETED","Baltimore","Maryland","21223","United States",{"lat":201,"lon":202},39.29038,-76.61219,{"facility":204,"status":7,"city":205,"state":206,"zip":207,"country":199,"contacts":208,"geoPoint":217},"Stanley Street Treatment and Resources","Fall River","Massachusetts","02720",[209,214],{"name":210,"role":211,"phone":212,"email":213},"Research Hotline","CONTACT","508-324-3522","Research@sstar.org",{"name":215,"role":216},"Genie Bailey","PRINCIPAL_INVESTIGATOR",{"lat":218,"lon":219},41.70149,-71.15505,{"facility":221,"status":7,"city":222,"state":222,"zip":223,"country":199,"contacts":224,"geoPoint":231},"NYU Langone Health","New York","10016",[225,229],{"name":226,"role":211,"phone":227,"email":228},"Mat Kladney","929 573 0673","mathew.kladney@nyulangone.org",{"name":230,"role":216},"Mathew Kladney, MD",{"lat":232,"lon":233},40.71427,-74.00597,{"facility":235,"status":7,"city":236,"state":237,"zip":238,"country":199,"contacts":239,"geoPoint":249},"Pennsylvania Psychiatric Institute","Harrisburg","Pennsylvania","17110",[240,243,247],{"name":241,"role":211,"email":242},"Subi Upadhyay","supadhyay1@pennstatehealth.psu.edu",{"name":244,"role":211,"phone":245,"email":246},"Angela Spangler","(717) 683-7838","aspangler@pennstatehealth.psu.edu",{"name":248,"role":216},"Sarah Kawasaki, MD",{"lat":250,"lon":251},40.2737,-76.88442,[253,257],{"name":254,"role":211,"phone":255,"email":256},"Jennifer Nyland, PhD","717-531-6172","jnyland@pennstatehealth.psu.edu",{"name":258,"role":211,"phone":259,"email":260},"Kirsten Shuler, MSc","717-531-4104","kshuler@pennstatehealth.psu.edu",[262],{"name":254,"affiliation":12,"role":216},[264,268],{"pmid":265,"type":266,"citation":267},"41168808","DERIVED","Freet CS, Shuler K, Kawasaki S, Weintraub E, Greenblatt A, Kladney M, Nunes E, Foster KL, Kong L, Raja-Khan N, Cleveland HH, Grigson PS, Bunce SC, Brick TR, Nyland JE. Efficacy of the GLP-1 receptor agonist, semaglutide, in abstinence from illicit and nonprescribed opioids in an outpatient population with OUD: a randomized, double-blind, placebo-controlled clinical trial protocol. Addict Sci Clin Pract. 2025 Oct 30;20(1):89. doi: 10.1186\u002Fs13722-025-00618-2.",{"pmid":269,"type":266,"citation":270},"40502777","Freet CS, Shuler K, Kawasaki S, Weintraub E, Greenblatt A, Kladney M, Nunes E, Foster KL, Kong L, Raja-Khan N, Cleveland HH, Grigson PS, Bunce SC, Brick TR, Nyland JE. Efficacy of the GLP-1 receptor agonist, semaglutide, in abstinence from illicit and nonprescribed opioids in an outpatient population with treatment-refractory OUD: A randomized, double-blind, placebo-controlled clinical trial protocol. Res Sq [Preprint]. 2025 May 26:rs.3.rs-6666196. doi: 10.21203\u002Frs.3.rs-6666196\u002Fv1.",[],{"nct_id":4,"conditions":273,"biomarkers":274},[18],[],{"nct_id":4,"found":14,"summary":276,"prompt_version":285},{"design":277,"status":278,"heading":6,"summary":279,"follow_up":280,"word_count":281,"commitments":282,"compensation":283,"drugs_mentioned":284},"This is an interventional study comparing semaglutide to a placebo in about 200 participants. Participants will be randomly assigned to receive either semaglutide or placebo.","completed","This study is investigating whether semaglutide, a drug given by injection pen, can help reduce the use of illicit (illegal) and nonprescribed opioids in adults. You could be eligible if you are between 18 and 75 years old, have a body mass index (BMI) over 18, and have an opioid use disorder. You must also be receiving buprenorphine or methadone treatment. The study will compare semaglutide to a placebo (a dry needle stick with no medicine) to see if semaglutide increases the number of participants who are abstinent from illicit and nonprescribed opioids at weeks 2, 3, and 4 of the study. The study aims to enroll 200 participants, but its current status is unclear.","After 12 weeks of treatment, participants will discontinue the study intervention and be observed for an additional week.",115,"You would receive weekly injections of semaglutide or placebo for 12 weeks in an outpatient setting. There will be a baseline evaluation and data collection period before treatment begins.","Not stated in the trial record.",[48],"v2"]