[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"suvorexant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:suvorexant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27,28,29],"Suvorexant","Placebo","Opioid Use Disorder",[31,32,27,33,34],"Opioid use disorder","Insomnia","Fentanyl","Buprenorphine","RECRUITING","2025-08-07",{"date":38,"type":39},"2025-08-11","ACTUAL",{"date":41,"type":39},"2022-03-30",{"date":43,"type":21},"2026-08",{"name":45,"class":46},"Johns Hopkins University","OTHER"]