[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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)","SUV","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":21,"type":22},76,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Alcohol Use Disorder (AUD)","Post Traumatic Stress Disorder (PTSD)","Insomnia","RECRUITING","2026-06-18",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":35},"2025-07-16",{"date":39,"type":22},"2027-03",{"name":41,"class":42},"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100541864","phase-1-effect-of-sublingual-formulation-of-dexmedetomidine-hydrochloride-hcl-bxcl501---outpatient-study-100541864","NCT06335407","Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study","Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) on Ethanol in Heavy Drinkers With PTSD - Outpatient Study","Inclusion Criteria:\n\n1. Veterans and non-Veterans, ages 21 to 65;\n2. Able to read and write in English and sign the informed consent;\n3. Willing to comply with all study procedures and be available for the duration of the study;\n4. ECG that demonstrates no clinically significant conduction issues or arrhythmias;\n5. Have no clinically significant contraindications, in the judgement of the PI\u002Fstudy physician, for study participation (based on self-reported medical history and brief physical examination);\n6. Have a current diagnosis of Alcohol use disorder (AUD) (mild, moderate, or severe) as determined by MINI-5;\n7. Have a lifetime traumatic event in their lifetime that meets Criterion A for PTSD as determined by screening interview and the MINI-5;\n8. Have a PCL-5 score \\> 15 prior to starting the study medication;\n9. Must have \\> 1 heavy drinking episodes (\\>4 standard drink units (SDU) for men; \\>3 SDU for women) in the last 30 days (assessed by the Timeline Follow Back (TLFB));\n10. Females of childbearing potential (not surgically sterilized (tubal ligation\u002Fhysterectomy) or not post-menopausal (no menstrual period for \\> 6 months)) must be willing to use a medically acceptable and effective birth control method for 1 month before the study and while participating in the study. Medically acceptable methods of contraception that may be used by the participant include abstinence, birth control pills or patches, birth control implants, diaphragm, intrauterine device (IUD), or condoms.\n\nExclusion Criteria:\n\n1. Current bipolar disorder or psychotic disorders as determined by MINI-5;\n2. Current diagnosis of a substance use disorder (other than alcohol, nicotine, or marijuana) as determined by MINI-5;\n3. Females who are pregnant, nursing, or planning to become pregnant during study participation;\n4. Current physiological alcohol dependence requiring a higher level of care (e.g., detox) as determined by study physician conducting physical examination and CIWA score. Tolerance to alcohol will be allowed.\n5. Recent history of complicated alcohol withdrawal, alcohol withdrawal seizures, or delirium tremens (DTs);\n6. Score \\> 4 on Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) at screening;\n7. History of major medical illnesses including liver disease, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the participant to be in the study;\n8. Clinically significant history of cardiac disease including (a) chronic hypertension (even if adequately controlled by antihypertensive medications); (b) history of syncope or other syncopal attacks; (c) current evidence of orthostatic hypotension (defined as a decrease in systolic BP of 20 mm Hg or decrease in diastolic BP of 10mm Hg within 3 minutes); (d) resting heart rate of \\\u003C55 beats per minute; (e) systolic blood pressure \\\u003C110mmHg or diastolic BP \\\u003C70mmHg; or (f) participants with a QTC interval \\>440msec (males) or \\>460msec (females).\n9. Clinically significant medical conditions including hepatic (ascites, bilirubin \\>10% above the upper limit of normal \\[ULN\\] or liver function tests \\[LFT\\] \\>3 × ULN);\n10. Renal impairment as measured by BUN\u002FCreatinine;\n11. Currently taking the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation including sedative\u002Fhypnotics, barbiturates, antihistamines, sedative antidepressants (e.g. doxepin, mirtazapine, trazodone), and triptans (e.g., sumatriptan); c) antihypertensive medications; d) alpha-2-adrenergic agonists (clonidine, guanfacine, lofexidine); or adrenergic agents prescribed for other reasons are excluded (prazosin). (Permitted Concomitant Medications: The concomitant medications allowed in the study include non-sedative antidepressants used to treat PTSD);\n12. History of allergic reactions to dexmedetomidine or known allergy to dexmedetomidine;\n13. Participation in a clinical trial of a pharmacological agent within 30 days prior to screening;\n14. Any finding that, in the view of the principal investigator, would compromise the subject's ability to fulfill the study visit schedule or requirements",{"count":52,"type":22},10,[54],"PHASE1","The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials.",[28,29],[58,29,59,60,61],"Alcohol Used Disorder (AUD)","Alcohol Use","Heavy Drinkers","Dexmedetomidine HCl (BXCL501)","2025-10-23",{"date":64,"type":35},"2025-10-27",{"date":66,"type":35},"2025-07-28",{"date":68,"type":22},"2026-05-31",{"name":41,"class":42},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":4},"100560691","phase-2-brexanolone-to-target-concurrent-ptsd-and-stress-induced-alcohol-use-in-veterans-a-dose-finding-study-100560691","NCT06580444","Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study","Brexanolone to Target Concurrent Posttraumatic Stress Disorder (PTSD) and Stress Induced Alcohol Use in Veterans: A Dose Finding Study","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, aged 21-70 years old, either active duty or with a history of US military service.\n4. Current DSM-5 diagnostic criteria for AUD (mild, moderate, or severe) within 6 months at the time of the intake, as measured via Quick Structured Clinical Interview for DSM-5 (QuickSCID-5), as well as the following drinking criteria (measured by the Timeline Followback):\n\n   1. Men: drink greater than 14 drinks per week and exceed five drinks per day at least once per week within the past 30 days at the time of intake.\n   2. Women: drink greater than 7 drinks per week and exceed four drinks per day at least once per week within the past 30 days at the time of intake.\n   3. Men and women will not endorse a desire to completely abstain from alcohol use at any point during the study. It will be necessary to confirm, via self-report (TLFB), consumption of alcohol within the week prior to the alcohol laboratory sessions. In the event the TLFB indicates recent abstinence, participants will be explicitly queried regarding desire to completely abstain from alcohol use moving forward, utilizing a one question item. If a patient completes the drug administration session, but then endorses desire to abstain completely he\u002Fshe will be followed via observation and not participate in laboratory sessions, in which alcohol is self-administered.\n5. Have a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total score ≥26 for the past month at intake, as well as a PTSD Checklist for DSM-5 (PCL-5) total score ≥31 for the past month at intake.\n6. Not currently taking medications thought to influence alcohol consumption such as Acamprosate, formulations of naltrexone, topiramate, ondansetron, baclofen, disulfiram, or gabapentin within 30 days prior to enrollment.\n7. Females of childbearing potential, who are not surgically sterilized (tubal ligation\u002Fhysterectomy) or not post-menopausal (no menstrual period for \\> 6 months) must be willing to use a medically acceptable and effective birth control method for at least 1 month prior to screening, randomization and intake and while participating in the study. Medically acceptable methods of contraception that may be used by the participant include abstinence, birth control pills, patches, implants, injections, rings, diaphragm, intrauterine device (IUD), or condoms.\n\nExclusion Criteria:\n\n1. Meets current DSM-5 diagnostic criteria for schizophrenia, bipolar disorder, and\u002For other severe mental illnesses, as defined by the QuickSCID-5 at intake. Please note that the QuickSCID-5 provides a Psychotic Symptom Screen. In the event, a patient screens positive for psychotic symptoms, the study team member will administer Modules B (Psychotic and Associated Symptoms) and C (Differential Diagnosis of Psychotic Disorders) from the Structured Clinician Interview for DSM-5 Clinician Version to determine a diagnosis of schizophrenia or another psychotic disorder.\n2. Increased risk of suicide that necessitates inpatient treatment or warrants therapy excluded by the protocol, and\u002For a current suicidal plan, per investigator's clinical judgement during interview.\n3. Treatment with trauma-focused therapy (e.g., Cognitive Processing Therapy, Prolonged Exposure Therapy, or Eye Movement Desensitization \\& Reprocessing Therapy) for PTSD within two weeks of intake (if participant is receiving therapy, he\u002Fshe must complete treatment prior to entering study). Note: Supportive psychotherapy in process at time of Screening may be continued.\n4. Meets criteria for current diagnosis of moderate or severe non-alcohol substance use disorder (except for caffeine and nicotine), as measured via QuickSCID-5, during the preceding 1 month relative to intake, per PI discretion, based on participant's screening interview.\n5. Tests positive for illicit substances during urine toxicology screens (except cannabis) at intake session. Patients who utilize cannabis but do not meet substance use disorder criteria are permitted.\n6. Self-reported past 30-day use at intake of psychoactive drugs (except cannabis), including opioids, CNS depressants (such as benzodiazepines), use of psychotropic medications in the class of antipsychotics, mood stabilizers, or stimulants. Note: Participant use of stable doses (prescribed for \\>2 months and the current dose has been stable or ≥3 weeks at intake) of antidepressants will be reviewed by Study MD.\n7. Likely to exhibit clinically significant alcohol withdrawal during the study. Specifically, we will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, assessed during physical examination as part of intake procedures or b) have a score of \\> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointment. Participants must have a CIWA-Ar score of \\\u003C 8 prior to randomization.\n8. Any clinically significant, uncontrolled, or medical\u002Fsurgical condition, that at the discretion of the investigator, would contraindicate use of brexanolone, or limit ability to complete study assessments, including end stage renal disease, significant arrhythmia or heart block, or heart failure, severe thrombocytopenia or hemophilia, severe hepatic failure, complete hearing loss, and\u002For need for surgery that might interfere with ability to participate. Such conditions will be assessed by the Study MD based upon physical examination (including review of medical history), as well as review of medical records, ECG and basic blood chemistries (i.e., CBC).\n9. Females who are pregnant, nursing, planning to become pregnant or fail to use one of the following methods of birth control during study participation (unless she or her partner is surgically sterile, or she is postmenopausal). Birth control includes: hormonal contraceptives (oral, implant, injection, patch, or ring), contraceptive sponge, double barrier (diaphragm or condom plus spermicide) or IUD.\n10. Any finding that, in the view of the principal investigator, would compromise the subject's ability to fulfill the study visit schedule or requirements.","70 Years",{"count":80,"type":22},40,[25],"The purpose of this research study is to find out how Zulresso®\u002Fbrexanolone influences Posttraumatic Stress Disorder (PTSD) symptoms and alcohol use.",[28,29],[58,29,59,60,85],"Brexanolone","NOT_YET_RECRUITING","2025-05-27",{"date":89,"type":35},"2025-05-31",{"date":66,"type":22},{"date":92,"type":22},"2027-03-19",{"name":41,"class":42},""]