protocolSection identificationModule nctId: NCT06323824, orgStudyIdInfo id: 2000033271, secondaryIdInfos id: CTN-0131, type: OTHER, domain: Clinical Trials Network, secondaryIdInfos id: 5UG1DA015831-21, type: NIH, link: https://reporter.nih.gov/quickSearch/5UG1DA015831-21, briefTitle: Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute on Drug Abuse (NIDA), collaborators name: The Emmes Company, LLC, collaborators name: University of California, San Francisco, collaborators name: Boston Medical Center (BMC), collaborators name: Hennepin Healthcare Research Institute, collaborators name: Alameda Health System, collaborators name: Marshall Health, collaborators name: Kaiser Permanente, descriptionModule briefSummary: The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or 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., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The comparative effectiveness of two strategies to address retention in medication for opioid use disorder (MOUD) treatment will be tested over a 168-day period. Behavioral treatments offered to patients are designed to be similar across the two medication conditions.Office-based methadone where the clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy. Providers and Randomized Control Trial (RCT) participants will have flexibility to use behavioral and pharmacological services as clinically indicated.Office-based buprenorphine (BUP) where the clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). Providers and RCT participants will have flexibility to use behavioral and pharmacological services as clinically indicated., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Methadone, interventions name: Buprenorphine (BUP), outcomesModule primaryOutcomes measure: 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization., secondaryOutcomes measure: Number of days of self-reported non-prescribed opioid use per month., secondaryOutcomes measure: Number of days of self-reported non-prescribed stimulant use per month., secondaryOutcomes measure: Number of days of self-reported non-prescribed benzodiazepine use per month., secondaryOutcomes measure: Urine toxicology, secondaryOutcomes measure: Participant satisfaction with MOUD, secondaryOutcomes measure: Total number of self-reported overdose events per total number of participant days at risk., secondaryOutcomes measure: Total number of self-reported injection drug use related events per total number of participant days at risk., secondaryOutcomes measure: Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity.", secondaryOutcomes measure: Number of self-reported days with acute care utilization (ED or hospitalization) events during the 168 days post-randomization per month., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False