[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478587":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":73,"collaborators":32,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":32,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":32,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":32,"overallStatus":58,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"opioid stepwise taper + buspirone","EXPERIMENTAL","up to 45mg\u002Fday buspirone during the opioid stepwise taper",[13],"Drug: Buspirone",{"label":15,"type":16,"description":17,"interventionNames":18},"opioid stepwise taper + lofexidine","ACTIVE_COMPARATOR","up to 2.16mg\u002Fday lofexidine during the opioid stepwise taper",[19],"Drug: Lofexidine",{"label":21,"type":22,"description":23,"interventionNames":24},"opioid stepwise taper + placebo","PLACEBO_COMPARATOR","placebo during the opioid stepwise taper",[25],"Drug: Placebo",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Buspirone","Buspirone administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Lofexidine","Lofexidine administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).",[15],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Placebo","Participants administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).",[21],[42],{"name":43,"affiliation":44,"role":45},"Cecilia Bergeria, Ph.D.","Johns Hopkins University","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":32,"email":50},"CONTACT","410-550-1979","cberge21@jhmi.edu",{"name":52,"role":48,"phone":53,"phoneExt":32,"email":54},"Caitlyn Grubb, B.S.","410-550-0490","cgrubb7@jhmi.edu",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Kahlert Institute for Addictino Medicin","RECRUITING","Baltimore","Maryland","21224","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-76.61219,39.29038,{"lat":68,"lon":67},[71,72],{"name":43,"role":48,"phone":49,"phoneExt":32,"email":50},{"name":43,"role":45,"phone":32,"phoneExt":32,"email":32},{"type":74,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100478587","phase-2-evaluating-buspirone-to-treat-opioid-withdrawal-100478587",false,"NCT05511909","Evaluating Buspirone to Treat Opioid Withdrawal","Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal","Inclusion Criteria:\n\n* Aged 18-75\n* Opioid positive urine sample\n* Current moderate-severe opioid use disorder with evidence of physical dependence\n* Interested in undergoing opioid detoxification\n\nExclusion Criteria:\n\n* Being pregnant or breastfeeding\n* Enrolled in methadone or buprenorphine maintenance treatment\n* Allergic to study medication or taking medications that are contraindicated with study medication (e.g., CYP3A4 inhibitors or inducers and\u002For monoamine oxidase (MAO) inhibitors)\n* Significant mental health or physical disorder, or life circumstance, that is expected to interfere with study participation (detailed further in protection of human subjects form).\n* Hypotension and\u002For prolonged QTc interval","ALL","18 Years","75 Years",{"count":86,"type":87},100,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","The investigators propose a rigorous, Phase II, three-group, placebo-controlled double-blind randomized controlled trial (RCT) to evaluate the efficacy of buspirone for both withdrawal and craving among individuals with opioid use disorder (OUD) undergoing a standardized stepwise taper. During this 10 to 12-day residential study, participants with OUD will be enrolled, stabilized on a short-acting opioid, undergo an opioid stepwise taper, and complete a post-taper observation period where participants will have the opportunity to initiate long-term buprenorphine or extended-release naltrexone.",[93,94,95,96],"Opioid Use Disorder","Opioid Withdrawal","Opioid Craving","Anxiety","2026-04-27",{"date":99,"type":100},"2026-05-01","ACTUAL",{"date":102,"type":100},"2023-03-15",{"date":104,"type":87},"2027-03-31",{"name":5,"class":6},1]