[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540437":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":35,"responsibleParty":55,"collaborators":57,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High Maintenance Daily Dose (24mg)","EXPERIMENTAL","The experimental intervention is a high daily maintenance dose of buprenorphine (24 mg) plus any usual clinical care the participant receives at the clinic. This high daily dose is the upper limit of the FDA-approved dose range and was selected based on preclinical studies, clinician anecdotes, case reports, and retrospective analyses suggesting improved effectiveness of higher buprenorphine doses among patients with a history of fentanyl use. Underlying pharmacodynamic principles support that the 24 mg daily dose of buprenorphine is likely to be well-tolerated, safe, and better control cravings among people with a history of fentanyl use.",[13],"Drug: Buprenorphine",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Maintenance Daily Dose (16mg)","ACTIVE_COMPARATOR","The control intervention is the FDA-recommended target daily maintenance dose of buprenorphine (16 mg) plus any usual clinical care the participant receives at the clinic.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Buprenorphine","Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown.",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Jackie Goldman","CONTACT","401-808-6950","jacqueline_goldman1@brown.edu",{"name":33,"role":29,"phone":25,"phoneExt":25,"email":34},"Rachel Wightman, MD","rachel_wightman@brown.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Brown University","RECRUITING","Providence","Rhode Island","02912","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-71.41283,41.82399,{"lat":48,"lon":47},[51,52],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},{"name":53,"role":54,"phone":25,"phoneExt":25,"email":25},"Francesca Beaudoin","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":53,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Professor of Epidemiology and Emergency Medicine",[58],{"name":37,"class":6},"100540437","phase-2-identifying-optimal-buprenorphine-dosing-for-opioid-use-disorder-treatment-and-prevention-of-overdose-100540437",false,"NCT06316830","Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose","Randomized Clinical Trial of a 16 mg vs. 24 mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People With Opioid Use Disorder","Optimal Bup","Inclusion Criteria:\n\n* English-speaking\n* Age 18 years-old or older\n* Identified by the treating physician as having moderate to severe opioid use disorder (OUD)\n* Initiating or continuing buprenorphine for treatment of opioid use disorder\n* History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)\n\nExclusion Criteria:\n\n* Previous enrollment in the trial\n* Incarcerated or in police custody\\*\n* Pregnant\n* Live outside of Rhode Island (RI)\n* Unable to provide informed consent\n* Allergy to Buprenorphine\n* Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \\*Participants that become incarcerated\u002For in police custody during the study will be withdrawn.","ALL","18 Years",{"count":70,"type":71},250,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE2","PHASE3","The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).\n\nThe main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).",[78],"Opioid Use Disorder","2025-10-21",{"date":81,"type":82},"2025-10-23","ACTUAL",{"date":84,"type":82},"2025-01-06",{"date":86,"type":71},"2027-11-01",{"name":5,"class":6},1]