[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450459":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suvorexant","EXPERIMENTAL","Nightly dosing of suvorexant",[13],"Drug: Suvorexant",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Nightly dosing of placebo",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Encapsulated suvorexant (matched for color, weight, and size)",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Encapsulated placebo (matched for color, weight, and size)",[15],[30],{"name":31,"affiliation":5,"role":32},"Andrew S Huhn, Ph.D.","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","410-550-1971","ahuhn1@jhu.edu",{"name":39,"role":35,"phone":40,"phoneExt":25,"email":41},"Kelly E Dunn, Ph.D.","410-550-2254","kdunn9@jhmi.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Johns Hopkins Bayview Medical Center","RECRUITING","Baltimore","Maryland","21224","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-76.61219,39.29038,{"lat":55,"lon":54},[58],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[62],{"name":63,"class":64},"National Institute on Drug Abuse (NIDA)","NIH","100450459","phase-2-suvorexant-as-an-adjunct-to-buprenorphine-in-persons-who-use-fentanyl-100450459",false,"NCT05145764","Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl","Suvorexant as an Adjunct to Buprenorphine Induction and Maintenance in Persons Who Use Fentanyl","Inclusion Criteria:\n\n* Aged 18-65\n* Meets DSM-5 criteria for opioid use disorder (OUD) with evidence of physical dependence on opioids\n* Provides a urine sample that tests positive for fentanyl and\u002For fentanyl analogues\n* Interest in being maintained on buprenorphine for OUD\n* Plans to reside in current area for study period\n* Achieving a study maintenance dose of \\>=8mg sublingual buprenorphine\u002Fnaloxone\n* Willing to comply with study protocol\n* Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation\n\nExclusion Criteria:\n\n* Medically contraindicated for buprenorphine, extended-release (XR)-buprenorphine (Sublocade), or suvorexant (as per medication labels)\n* Pregnant or breast feeding\n* Severe Diagnostic and Statistical Manual (DSM)-5 alcohol or benzodiazepine use disorder or evidence of alcohol\u002Fbenzodiazepine physical dependence\n* Have a known allergy to the study medications\n* Past 30-day prescribed use of suvorexant for the indication of insomnia\n* Current benzodiazepine or other prescribed medication for the indication of insomnia\n* Urine sample testing positive for benzodiazepine at screening and admission to residential treatment\n* Current narcolepsy, restless leg syndrome or sleep paralysis\n* High risk for current sleep apnea\n* Current (past 30-day) suicidal behaviors\n* Severe hepatic or renal impairment\n\n  * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3x upper limit of normal (ULN)\n  * Total bilirubin \\>2x ULN\n  * Creatinine \\>1.5x ULN\n* Past year clinically-significant psychiatric condition judged to interfere with study participation\n* Lack of access to stable housing (necessary for electronic pill dispenser charging)\n* Have circumstances that would interfere with study participation (e.g., impending jail)","ALL","18 Years","65 Years",{"count":76,"type":77},120,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This is a 4-week, randomized-controlled trial of suvorexant vs placebo in persons with opioid use disorder who have recent fentanyl exposure. Participants will first undergo a 5-day residential phase wherein participants are stabilized on sublingual buprenorphine\u002Fnaloxone, followed by a 3-week outpatient phase wherein participants are maintained on sublingual buprenorphine\u002Fnaloxone and transitioned to extended-release buprenorphine).",[9,15,83],"Opioid Use Disorder",[85,86,9,87,88],"Opioid use disorder","Insomnia","Fentanyl","Buprenorphine","2025-08-07",{"date":91,"type":92},"2025-08-11","ACTUAL",{"date":94,"type":92},"2022-03-30",{"date":96,"type":77},"2026-08",{"name":5,"class":6},1]