[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06323824":3,"trial-entities:NCT06323824":222,"trial-summary:NCT06323824":225},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":46,"sex":82,"minimum_age":83,"maximum_age":84,"healthy_volunteers":85,"eligibility_criteria":86,"std_ages":104,"locations":107,"central_contacts":207,"overall_officials":217,"references":220,"see_also_links":221},"NCT06323824","2000033271","Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.","Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness\u002FImplementation Trial","RECRUITING","2028-12","2026-04","2026-05-05","2024-06-04","Yale University","OTHER",true,"The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and\u002For dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.","This study is a randomized, pragmatic hybrid type 1 effectiveness\u002Fimplementation multisite (approximately 6 sites) trial to determine whether office-based methadone with pharmacy administration and\u002For dispensing or buprenorphine (BUP) results in greater treatment retention in approximately 600 patients with opioid use disorder (OUD). This trial will also identify implementation barriers, facilitators and acceptability at the patient, provider and health-systems level for office-based methadone with pharmacy administration and\u002For dispensing.\n\nAn ancillary extended study was added to this trial in January of 2026. A sub-set of current participants that were receiving office based methadone as of day 168 of the parent study will continue to be followed for other pre-specified outcomes.",[19],"Opioid Use Disorder",[19,21,22],"Methadone","Buprenorphine","INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},600,"ESTIMATED",[31,36],{"type":32,"name":21,"description":33,"armGroupLabels":34},"DRUG","Drug: Methadone\n\nPossible formulations:\n\n10 and 50 mg tablets",[35],"Office-based methadone",{"type":32,"name":37,"description":38,"armGroupLabels":39},"Buprenorphine (BUP)","Drug: Buprenorphine (BUP)\n\nPossible formulations:\n\nA. Buprenorphine 225 mcg to 24 mg 225 mcg to 32 mg per day\n\nB. Buprenorphine (Extended release) 300 mg q 28 days (Sublocade) 100 mg q 28 days (Sublocade) 8 mg q 7 days (Brixadi) 16 mg q 7 days (Brixadi) 24 mg q 7 days (Brixadi) 32 mg q 7 days (Brixadi) 64 mg q 7 28 days (Brixadi) 96 mg q 7 28 days (Brixadi) 128 mg q 7 28 days (Brixadi)",[40],"Office-based buprenorphine (BUP)",[42],{"measure":43,"description":44,"timeFrame":45},"Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.","MOUD dispensed to the participant including medication, duration of prescription and daily dose prescribed data will be extracted from the state prescription drug monitoring program (PDMP) and the electronic medical record (EMR).","up to Day 168",[47,50,53,55,58,61,63,66,69,72,76,79],{"measure":48,"description":49,"timeFrame":45},"Number of self-reported days in any FDA-approved formulation of MOUD treatment (e.g., buprenorphine, methadone or naltrexone) during the 168 days post-randomization.","The MOUD Calendar Based Recall (Self-Report) form is used to collect self-reported prescribed medications for OUD.",{"measure":51,"description":52,"timeFrame":45},"Number of self-reported days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization.","This information will be obtained from one or more of the following:\n\nHealth Services Utilization instrument, a brief structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received, Timeline Followback Medications, MOUD Calendar Based Recall, and Treatment Dates instruments.",{"measure":54,"description":44,"timeFrame":45},"Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization.",{"measure":56,"description":57,"timeFrame":45},"Number of days of self-reported non-prescribed opioid use per month.","The Opioid Use Calendar Based Recall instrument is used to collect self-reported non-prescribed opioid use.",{"measure":59,"description":60,"timeFrame":45},"Number of days of self-reported non-prescribed stimulant use per month.","The Timeline Followback instrument collects self-reported drug and alcohol use.",{"measure":62,"description":60,"timeFrame":45},"Number of days of self-reported non-prescribed benzodiazepine use per month.",{"measure":64,"description":65,"timeFrame":45},"Urine toxicology","Number of monthly urines negative for non-prescribed opioids during the 168 days post-randomization. Non-prescribed opioids will be determined using the Opioid Use Calendar Based Recall self-report.",{"measure":67,"description":68,"timeFrame":45},"Participant satisfaction with MOUD","Proportion of RCT participants who report at the assessment scheduled to be collected on day 28 that the medication they received was at least \"Somewhat helpful\" on the Satisfaction with MOUD Provider Scale instrument.",{"measure":70,"description":71,"timeFrame":45},"Total number of self-reported overdose events per total number of participant days at risk.","The Overdose Calendar Recall instrument collects overdose events.",{"measure":73,"description":74,"timeFrame":75},"Total number of self-reported injection drug use related events per total number of participant days at risk.","Assessment of Infectious or Other Complications of Injection Drug Use assess for self-report of skin or soft-tissue infections, osteoarticular infections (septic arthritis, osteomyelitis, epidural abscess), endovascular infections including endocarditis, or new injection-related viral infections.","Up to Day 168",{"measure":77,"description":78,"timeFrame":75},"Pain measured using PEG-3: \"Pain average,\" \"interference with Enjoyment of life,\" and \"interference with General activity.\"","Mean scores on the PEG-3 screening instrument over time. Total score range is 0-10; the highest being the worse pain.",{"measure":80,"description":81,"timeFrame":75},"Number of self-reported days with acute care utilization (ED or hospitalization) events during the 168 days post-randomization per month.","The Health Services Utilization instrument is a brief, structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment) and self-help sources of support (e.g., NA). Also assessed are receipt of formal and informal addiction and mental health treatment services RCT participants might have received outside the study interventions.","ALL","18 Years","99 Years",false,{"inclusion":87,"exclusion":91,"raw_text":103},[88,89,90],"18 years of age or older;","Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OUD;","Are initiating a new MOUD treatment episode",[92,93,94,95,96,97,98,99,100,101,102],"Have been prescribed (and ingested) or been administered more than 72 hours of MOUD in the 7 days prior to randomization as a \"bridge\" to the new OUD treatment episode. Such MOUD may include prescribed (and ingested) or administered medically managed withdrawal (aka detoxification).","Known contraindication to methadone or BUP","Unwilling to pursue or continue pre-natal care or pregnancy counseling if determined pregnant by urine human chorionic gonadotropin (hCG) testing at the screening assessment","Be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site clinician","Current severe comorbid substance use disorder requiring residential or inpatient treatment services as determined by site clinician","Be unable to provide locator information including one or more contacts in addition to themselves","Be unwilling to follow study procedures (e.g., unwilling to receive treatment from site clinician, use the study pharmacy, unwilling to be randomized to BUP or methadone, or will be unavailable for the follow-up assessments) including allowing the researchers to access their record in the EMR and state's prescription drug monitoring program","Have previously enrolled in CTN-0131","Currently enrolled in another research study which will conflict with study procedures","Are currently in jail, prison or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities","Unable to conduct research assessments in English as determined by Site PI or their designee.","Inclusion Criteria\n\n* 18 years of age or older;\n* Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OUD;\n* Are initiating a new MOUD treatment episode\n\nExclusion Criteria\n\n* Have been prescribed (and ingested) or been administered more than 72 hours of MOUD in the 7 days prior to randomization as a \"bridge\" to the new OUD treatment episode. Such MOUD may include prescribed (and ingested) or administered medically managed withdrawal (aka detoxification).\n* Known contraindication to methadone or BUP\n* Unwilling to pursue or continue pre-natal care or pregnancy counseling if determined pregnant by urine human chorionic gonadotropin (hCG) testing at the screening assessment\n* Be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site clinician\n* Current severe comorbid substance use disorder requiring residential or inpatient treatment services as determined by site clinician\n* Be unable to provide locator information including one or more contacts in addition to themselves\n* Be unwilling to follow study procedures (e.g., unwilling to receive treatment from site clinician, use the study pharmacy, unwilling to be randomized to BUP or methadone, or will be unavailable for the follow-up assessments) including allowing the researchers to access their record in the EMR and state's prescription drug monitoring program\n* Have previously enrolled in CTN-0131\n* Currently enrolled in another research study which will conflict with study procedures\n* Are currently in jail, prison or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities\n* Unable to conduct research assessments in English as determined by Site PI or their designee.",[105,106],"ADULT","OLDER_ADULT",[108,126,145,160,175,190],{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":123},"Highland Hospital Bridge Clinic at Alameda Health System","Oakland","California","94602","United States",[115,120],{"name":116,"role":117,"phone":118,"email":119},"Jhoselyn Pineda","CONTACT","(510)214-3649","emboss.ctn0131@gmail.com",{"name":121,"role":122},"Monish Ullal, MD","PRINCIPAL_INVESTIGATOR",{"lat":124,"lon":125},37.80437,-122.2708,{"facility":127,"status":8,"city":128,"state":111,"zip":129,"country":113,"contacts":130,"geoPoint":142},"Outpatient Buprenorphine Induction Clinic, University of California, San Francisco","San Francisco","94103",[131,135,137,139],{"name":132,"role":117,"phone":133,"email":134},"Kristina Toma","415-254-0398","EMBOSS@ucsf.edu",{"name":136,"role":122},"Paula Lum, MD",{"name":138,"role":122},"Andy Tompkins, MD",{"name":140,"role":141},"Christine Soran, MD","SUB_INVESTIGATOR",{"lat":143,"lon":144},37.77493,-122.41942,{"facility":146,"status":8,"city":147,"state":148,"zip":149,"country":113,"contacts":150,"geoPoint":157},"Rapid Start Clinic, Kaiser Permanente Colorado","Denver","Colorado","80205",[151,155],{"name":152,"role":117,"phone":153,"email":154},"Jennifer Barrow","(303)-739-3666","EMBOSS@kp.org",{"name":156,"role":122},"Ingrid Binswanger, MD",{"lat":158,"lon":159},39.73915,-104.9847,{"facility":161,"status":8,"city":162,"state":163,"zip":164,"country":113,"contacts":165,"geoPoint":172},"Officed Based Addiction Treatment Program, Boston Medical Center","Boston","Massachusetts","02118",[166,170],{"name":167,"role":117,"phone":168,"email":169},"Emily Oot","857-283-7620","EMBOSS@bmc.org",{"name":171,"role":122},"Zoe Weinstein, MD",{"lat":173,"lon":174},42.35843,-71.05977,{"facility":176,"status":8,"city":177,"state":178,"zip":179,"country":113,"contacts":180,"geoPoint":187},"Hennepin Healthcare Addiction Medicine","Minneapolis","Minnesota","55415",[181,185],{"name":182,"role":117,"phone":183,"email":184},"Dat Nguyen","(763) 568-2785","EMBOSSstudy@bermancenter.org",{"name":186,"role":122},"Gavin Bart, MD",{"lat":188,"lon":189},44.97997,-93.26384,{"facility":191,"status":8,"city":192,"state":193,"zip":194,"country":113,"contacts":195,"geoPoint":204},"Marshall University Division of Addiction Sciences P.R.O.A.C.T","Huntington","West Virginia","25703",[196,200,202],{"name":197,"role":117,"phone":198,"email":199},"Brynn M Taylor","740-302-0845","taylor975@marshall.edu",{"name":201,"role":122},"Zachary Hansen, MD",{"name":203,"role":141},"Todd Davies, PhD",{"lat":205,"lon":206},38.41925,-82.44515,[208,212],{"name":209,"role":117,"phone":210,"email":211},"Jessica Research Associate","203-785-6821","j.mckenzie@yale.edu",{"name":213,"role":117,"phone":214,"phoneExt":215,"email":216},"Melissa Gordon","203-937-3486","7415","melissa.gordon@yale.edu",[218],{"name":219,"affiliation":13,"role":122},"David Fiellin, MD",[],[],{"nct_id":4,"conditions":223,"biomarkers":224},[19],[],{"nct_id":4,"found":15,"summary":226,"prompt_version":236},{"design":227,"status":228,"heading":229,"summary":230,"follow_up":231,"word_count":232,"commitments":233,"compensation":234,"drugs_mentioned":235},"This is a randomized study, meaning you would be randomly assigned to receive either methadone or buprenorphine. Approximately 600 people are expected to participate across several sites.","completed","Comparing Methadone and Buprenorphine for Opioid Use Disorder","This study is comparing two common medications for opioid use disorder (OUD): methadone and buprenorphine. Researchers want to see which medication helps people stay in treatment longer when given in an office setting. You might be able to join if you are 18 or older, have been diagnosed with OUD, and are starting a new treatment. The study will measure how many days you stay on your assigned medication (methadone or buprenorphine) for up to 168 days. This trial is currently unclear on its recruitment status.","Participants will be followed for up to 168 days after starting treatment. Some participants receiving office-based methadone may be followed for additional outcomes after this period.",86,"Not specified in the trial record.","Not stated in the trial record.",[21],"v2"]