[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550018":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":28,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":28,"enrollmentInfo":69,"targetDuration":28,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":37,"whyStopped":28,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"16mg Extended-Release Buprenorphine","EXPERIMENTAL","The first 10 participants will receive XR-BUP 16mg in single-blind fashion.",[13],"Drug: Extended-release Buprenorphine",{"label":15,"type":10,"description":16,"interventionNames":17},"24mg Buprenorphine","After first 10 participants have been completed, the next 10 participants will receive 24mg in a single-blind fashion.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"32mg Buprenorphine","After the 20 participants have been completed, the next 10 participants will receive 32mg in a single-blind fashion.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Extended-release Buprenorphine","The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.",[9,15,19],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Joji Suzuki","CONTACT","6177325752","jsuzuki2@bwh.harvard.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Boston","Massachusetts","02118-5605","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-71.05977,42.35843,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":28,"email":53},"Anika Clinical Research Coordinator","617-525-0676","akopczynski@bwh.harvard.edu",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Joji Suzuki, MD","Director, Division of Addiction Psychiatry",[59],{"name":60,"class":6},"University of Utah","100550018","phase-2-extended-release-buprenorphine-as-a-novel-low-dose-induction-strategy-100550018",false,"NCT06441604","Extended-release Buprenorphine as a Novel Low-dose Induction Strategy","Inclusion Criteria:\n\n* English speaking adults aged 18 and above.\n* diagnosis of opioid use disorder.\n* Self-reporting use of illicit opioids in \\>21 days in the prior 30 days.\n* Provide urine toxicology testing positive for fentanyl at baseline.\n\nExclusion Criteria:\n\n* Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.\n* Received buprenorphine or methadone treatment in prior 30 days.\n* Current diagnosis of alcohol or sedative\u002Fhypnotic use disorder.\n* Positive urine drug screen for benzodiazepines, alcohol and or methadone.\n* Physical dependence on alcohol or sedative\u002Fhypnotics.\n* Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed consent.\n* Have a history or diagnosis of Intracranial mass\u002Fbleed, seizure disorder, liver cirrhosis, renal failure, obstructive lung disease, hyperthyroidism, narrow-angle glaucoma, valvular heart disease, cardiac arrhythmias, heart failure.\n* Recent (within 6 months) head trauma, stroke, or myocardial infarction\n* Requiring treatment with opioids for acute or chronic pain.\n* History of hypersensitivity or allergy to buprenorphine or fentanyl.\n* Pregnant or breastfeeding.\n* Liver function test greater than 3 times upper normal limit.\n* Receiving medications that are strong or moderate CYP34A inducers or inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin), in the past 30 days.","ALL","18 Years",{"count":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.",[77],"Opioid Use Disorder",[77,79],"Buprenorphine","2026-06-24",{"date":82,"type":83},"2026-06-26","ACTUAL",{"date":85,"type":83},"2025-10-27",{"date":87,"type":71},"2027-01-31",{"name":5,"class":6},1]