[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568272":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":41,"locations":48,"responsibleParty":85,"collaborators":87,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":27,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":32,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":32,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"10mg and 20mg Suvorexant (SUV)","ACTIVE_COMPARATOR","Participants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)).",[13],"Drug: Suvorexant",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will be randomly assigned to receive matched placebo (Days 0-13).",[19],"Other: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Suvorexant","Suvorexant is described chemically as: \\[(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl\\]\\[5-methyl-2-(2H-1,2,3-triazol2-yl)phenyl\\]methanone. SUV's empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Each film coated tablet contains 10mg or 20mg of suvorexant.",[9],[27,28],"SUV","Dual orexin receptor antagonist",{"type":6,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"Film coated tablet to match the active drug.",[15],null,[34,38],{"name":35,"affiliation":36,"role":37},"Scott Lane, PhD","The University of Texas Health Science Center, Houston","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Lara Ray, PhD","University of California, Los Angeles",[42,46],{"name":35,"role":43,"phone":44,"phoneExt":32,"email":45},"CONTACT","713-486-2535","scott.d.lane@uth.tmc.edu",{"name":39,"role":43,"phone":32,"phoneExt":32,"email":47},"lararay@psych.ucla.edu",[49,69],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of California - Los Angeles","RECRUITING","Los Angeles","California","90095","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-118.24368,34.05223,{"lat":61,"lon":60},[64,65,68],{"name":39,"role":43,"phone":32,"phoneExt":32,"email":47},{"name":66,"role":43,"phone":32,"phoneExt":32,"email":67},"Jessica Jenkins","jenkinsj@ucla.edu",{"name":39,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":70,"status":51,"city":71,"state":72,"zip":73,"country":55,"countryCode":56,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"The University of Texas Health Science Center - Houston","Houston","Texas","77054",{"type":58,"coordinates":75},[76,77],-95.36327,29.76328,{"lat":77,"lon":76},[80,81,84],{"name":35,"role":43,"phone":32,"phoneExt":32,"email":45},{"name":82,"role":43,"phone":32,"phoneExt":32,"email":83},"Jessica Vincent","jessica.n.vincent@uth.tmc.edu",{"name":35,"role":37,"phone":32,"phoneExt":32,"email":32},{"type":86,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[88,89],{"name":40,"class":6},{"name":36,"class":6},"100568272","phase-2-suvorexant-for-treatment-of-aud-and-ptsd-100568272",false,"NCT06679062","Suvorexant for Treatment of AUD and PTSD","A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Age between 21 and 65.\n* Meet current (i.e., past 12-month at Day -7\u002F-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.\n* Currently experiencing PTSD symptoms at screening (Day -7\u002F-6) as indicated by PCL-5 cut-score \\> 30.\n* Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment.\n* Must have an ISI score equal to or \\> 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day.\n* Agree to abstain from all other sleep medications (starting at Day -7).\n* Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s\u002Fhe will lose his\u002Fher housing in the next month.\n\nExclusion Criteria:\n\n* A current (past 12-month at Day -7\u002F-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (\\\u003C moderate level on DSM 5).\n* A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.\n* Positive urine test for any recreational drugs other than marijuana at screening (Day -7\u002F-6).\n* Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).\n* Currently pregnant, nursing, or no reliable method of birth control (females only).\n* Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders).\n* Use of suvorexant (within 30 days of Day -7).\n* Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))\n* Hepatic insufficiency (AST\u002FALT \\> 5x upper limit of normal (ULN)).\n* Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.\n* Inability to provide evidence of 48-hour alcohol abstinence (self-report, BrAC, EtG) at Day 0 AND failure after second attempt at 48-hour abstinence.","ALL","21 Years","65 Years",{"count":101,"type":102},76,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.",[108,109,110],"Alcohol Use Disorder (AUD)","Post Traumatic Stress Disorder (PTSD)","Insomnia","2026-06-18",{"date":113,"type":114},"2026-06-23","ACTUAL",{"date":116,"type":114},"2025-07-16",{"date":118,"type":102},"2027-03",{"name":5,"class":6},2]