[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06679062":3,"trial-entities:NCT06679062":150,"trial-summary:NCT06679062":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":49,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":96,"locations":99,"central_contacts":135,"overall_officials":139,"references":144,"see_also_links":149},"NCT06679062","AS210006-A10","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)","RECRUITING","2027-03","2026-06","2026-06-23","2025-07-16","Pharmacotherapies for Alcohol and Substance Use Disorders Alliance","OTHER",true,"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.","This is a randomized, double-masked, placebo-controlled study to evaluate preliminary efficacy and safety of suvorexant (SUV) (20mg) for sleep disturbance in alcohol use disorder (AUD) and co-occurring posttraumatic stress disorder (PTSD) symptoms in approximately 76 randomized men and women veteran and non-veterans between the ages 21-65. Participants will be recruited from the University of Texas Health Science Center at Houston (UTHealth) Trauma and Recovery Center (TRC) and the University of California - Los Angeles (UCLA) (in collaboration with West Los Angeles VA Medical Center). Following a 7-day placebo run-in, participants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)) or matched placebo. Randomization will be stratified on sex and level of sleep disturbance (Insomnia Severity Index (ISI) score). Post-randomization, all participants will complete an alcohol cue-reactivity paradigm prior to the initial dose of study medication. The alcohol cue-reactivity paradigm is an established laboratory assessment of craving during which participants are exposed to real alcohol and water cues in a bar laboratory setting. Participants will then take their first dose of medication. Participants will begin the real-world quit attempt, during which they will attempt to stop drinking for two weeks. Participants will complete daily virtual diaries and visits to assess sleep, past-day drinking, and alcohol craving. Participants will return to one of the clinical sites on study Day 14 to complete an alcohol cue-reactivity session to assess post-medication craving. PTSD symptoms will be assessed via Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5) and Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) at baseline, at Day 7 and at Day 14 of treatment with SUV or matched placebo.",[19,20,21],"Alcohol Use Disorder (AUD)","Post Traumatic Stress Disorder (PTSD)","Insomnia",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},76,"ESTIMATED",[31,40],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"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.",[36],"10mg and 20mg Suvorexant (SUV)",[38,39],"SUV","Dual orexin receptor antagonist",{"type":14,"name":41,"description":42,"armGroupLabels":43},"Placebo","Film coated tablet to match the active drug.",[41],[45],{"measure":46,"description":47,"timeFrame":48},"Change in Insomnia Severity Index (ISI) score from baseline to Day 14.","The Insomnia Severity Index (ISI) is a brief questionnaire to screen for insomnia in participants. A scoring system is used to identify what degree insomnia (if any detected) is affecting daily life and sleep patterns. A total score is derived by summing all seven items with a total score ranging from 0 to 28 (with higher scores indicative of worse insomnia symptoms).","Baseline (Day 0) and Day 14",[50,53,56,60,64,67],{"measure":51,"description":52,"timeFrame":48},"Change in cue-induced alcohol craving, as assessed by the Alcohol Urge Questionnaire (AUQ) during the alcohol condition, from baseline to day 14.","The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from \"strongly disagree\" to \"strongly agree.\" Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Higher scores reflect greater craving.",{"measure":54,"description":55,"timeFrame":48},"Change in mean number of drinks per drinking day from baseline to Day 14.","Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption per day. Participants are given a blank calendar covering the time interval to be re-constructed and are asked to reconstruct retrospectively their drinking behavior over that interval. The TLFB will be used to calculate the number of drinks per day and drinks per drinking day over the course of the study period.",{"measure":57,"description":58,"timeFrame":59},"Percent total days abstinent during the 14-day quit attempt period.","Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption per day. Participants are given a blank calendar covering the time interval to be re-constructed and are asked to reconstruct retrospectively their drinking behavior over that interval. The TLFB will be used to document the total number of abstinent days over the course of the study period.","Baseline (Day 0) through Day 14",{"measure":61,"description":62,"timeFrame":63},"Change in the mean number of days abstinent during the medication period (day 0 through 14) compared to the 30-days prior (screening period).","Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption per day. Participants are given a blank calendar covering the time interval to be re-constructed and are asked to reconstruct retrospectively their drinking behavior over that interval. The TLFB will be used to document the number of days with and without drinking from 30-days prior to baseline and 14-days post randomization.","Screening (30-days prior to baseline) and Baseline through Day 14",{"measure":65,"description":66,"timeFrame":59},"Change in PTSD total symptom severity score as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline to Day 14.","Gold-standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The symptom severity score ranges from 0 to 80 with higher score indicating worse PTSD symptoms.",{"measure":68,"description":69,"timeFrame":59},"Change in PTSD score as measured by the PTSD Checklist for DSM-5 (PCL-5) from baseline to Day 14.","The PCL-5 is a 20-item self-report measure that assesses DSM-5-based criteria for PTSD symptoms. Each item is rated on a 5-point Likert-type scale (0 = Not at all; 4 = Extremely) that indicates how much the participant has been bothered by an identified \"worst\" stressful event in the past month. The PTSD score ranges from 0 to 80 with higher score indication worse PTSD symptoms.","ALL","21 Years","65 Years",false,{"inclusion":75,"exclusion":83,"raw_text":95},[76,77,78,79,80,81,82],"Age between 21 and 65.","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.","Currently experiencing PTSD symptoms at screening (Day -7\u002F-6) as indicated by PCL-5 cut-score \\> 30.","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.","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.","Agree to abstain from all other sleep medications (starting at Day -7).","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.",[84,85,86,87,88,89,90,91,92,93,94],"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).","A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.","Positive urine test for any recreational drugs other than marijuana at screening (Day -7\u002F-6).","Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).","Currently pregnant, nursing, or no reliable method of birth control (females only).","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).","Use of suvorexant (within 30 days of Day -7).","Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))","Hepatic insufficiency (AST\u002FALT \\> 5x upper limit of normal (ULN)).","Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.","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.","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.",[97,98],"ADULT","OLDER_ADULT",[100,119],{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":116},"University of California - Los Angeles","Los Angeles","California","90095","United States",[107,111,114],{"name":108,"role":109,"email":110},"Lara Ray, PhD","CONTACT","lararay@psych.ucla.edu",{"name":112,"role":109,"email":113},"Jessica Jenkins","jenkinsj@ucla.edu",{"name":108,"role":115},"PRINCIPAL_INVESTIGATOR",{"lat":117,"lon":118},34.05223,-118.24368,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":105,"contacts":124,"geoPoint":132},"The University of Texas Health Science Center - Houston","Houston","Texas","77054",[125,128,131],{"name":126,"role":109,"email":127},"Scott Lane, PhD","scott.d.lane@uth.tmc.edu",{"name":129,"role":109,"email":130},"Jessica Vincent","jessica.n.vincent@uth.tmc.edu",{"name":126,"role":115},{"lat":133,"lon":134},29.76328,-95.36327,[136,138],{"name":126,"role":109,"phone":137,"email":127},"713-486-2535",{"name":108,"role":109,"email":110},[140,142],{"name":126,"affiliation":141,"role":115},"The University of Texas Health Science Center, Houston",{"name":108,"affiliation":143,"role":115},"University of California, Los Angeles",[145],{"pmid":146,"type":147,"citation":148},"41630040","DERIVED","Ray LA, Nieto SJ, Miotto K, Mooney L, LeBeau R, Yoon JH, Schmitz JM, Acierno R, Bailey NW, Jenkins J, Vincent J, Nolen T, Hirsch S, Williams A, Lane SD. Suvorexant for alcohol use disorder and post-traumatic stress disorder: study protocol for a phase II randomized clinical trial. Trials. 2026 Feb 3;27(1):188. doi: 10.1186\u002Fs13063-026-09489-7.",[],{"nct_id":4,"conditions":151,"biomarkers":154},[152,21,153],"Alcohol use disorder","Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":15,"summary":156,"prompt_version":166},{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This is a randomized, double-masked (meaning neither you nor the study staff will know if you're getting the active drug or placebo), placebo-controlled study with about 76 participants.","completed","Suvorexant for Alcohol Use Disorder (AUD) and PTSD","This study is looking at whether suvorexant, a medication, can help reduce sleep problems (insomnia) in 76 men and women who have both alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) symptoms. Participants will be between 21 and 65 years old. You would first have a 7-day period where you receive a placebo (an inactive pill), then you would be randomly assigned to receive either suvorexant or a matching placebo for 14 additional days. During this time, you would try to stop drinking alcohol and complete daily diaries. The main goal is to see if suvorexant improves your insomnia score after 14 days.","Your insomnia will be measured at the start of the study (Day 0) and again on Day 14.",104,"You would have a 7-day placebo run-in period, followed by 14 days of receiving either suvorexant or placebo. You would also complete daily virtual diaries and attend in-person clinic visits on days 7 and 14.","Not stated in the trial record.",[33,41],"v2"]