nctId: NCT06335407 id: AS210006-A08 id: W81XWH-21-2-0026 type: OTHER_GRANT domain: DoDCongressionally Directed Medical Research Program briefTitle: Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-09-30 date: 2025-10-29 date: 2024-03-28 date: 2024-03-28 name: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance class: OTHER name: United States Department of Defense name: Congressionally Directed Medical Research Programs name: VA Connecticut Healthcare System name: BioXcel Therapeutics Inc name: Yale University name: RTI International briefSummary: 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. conditions: Alcohol Use Disorder (AUD) conditions: Post Traumatic Stress Disorder (PTSD) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Participants will receive 40µg on days 1-2. On days 3 and 4, participants will receive 40µg twice per day. On days 5 and 6 participants will receive 40µg in the morning and 80µg in the evening. If dosing is tolerated, per clinical judgement, participants will begin to receive 80µg twice per day on days 7-28. primaryPurpose: OTHER masking: NONE maskingDescription: no one will be masked count: 10 type: ESTIMATED name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg measure: Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28. measure: Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28. measure: Number and Proportion of Adverse Events measure: Change in PTSD symptoms (measured via the PTSD Checklist for Diagnostic and Statistical Manual (DSM-5) - Posttraumatic Stress Disorder Checklist (PCL-5) from baseline (pre-treatment) through day 28. measure: Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28. measure: Change in compulsive drinking (measured via the Obsessive Compulsive Drinking Scale - OCDS) from baseline (pre-treatment) through day 28. measure: Change in mood (measured by the Differential Emotions Scale - DES-R) from baseline (pre-treatment) through day 28. measure: Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28. measure: Change in affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28. measure: Change in overall functioning (measured by the Veteran's RAND 12-item Health Survey - VR-12) from baseline (pre-treatment) through day 28. measure: Change in cognitive functioning (measured by the Hopkins Verbal Learning Test Revised - HVLT-R) from baseline (pre-treatment) through day 28. measure: Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28. measure: Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28. sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Connecticut Healthcare System city: West Haven state: Connecticut zip: 06516 country: United States name: Jenelle Newcomb, BA role: CONTACT phone: 203-932-5711 phoneExt: 12874 email: jenelle.leblanc@yale.edu name: Ismene Petrakis, MD role: CONTACT phone: (203) 932-5711 phoneExt: 12244 email: ismene.petrakis@yale.edu name: Ismene Petrakis, MD role: PRINCIPAL_INVESTIGATOR name: John Krystal, MD role: SUB_INVESTIGATOR lat: 41.27065 lon: -72.94705 hasResults: False