protocolSection identificationModule nctId: NCT06335407, orgStudyIdInfo id: AS210006-A08, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-10-29, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, class: OTHER, collaborators name: United States Department of Defense, collaborators name: Congressionally Directed Medical Research Programs, collaborators name: VA Connecticut Healthcare System, collaborators name: BioXcel Therapeutics Inc, collaborators name: Yale University, collaborators name: RTI International, descriptionModule 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., conditionsModule conditions: Alcohol Use Disorder (AUD), conditions: Post Traumatic Stress Disorder (PTSD), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo 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, maskingInfo masking: NONE, maskingDescription: no one will be masked, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, interventions name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg, outcomesModule primaryOutcomes measure: Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28., primaryOutcomes measure: Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28., primaryOutcomes measure: Number and Proportion of Adverse Events, secondaryOutcomes 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., secondaryOutcomes measure: Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in compulsive drinking (measured via the Obsessive Compulsive Drinking Scale - OCDS) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in mood (measured by the Differential Emotions Scale - DES-R) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in overall functioning (measured by the Veteran's RAND 12-item Health Survey - VR-12) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in cognitive functioning (measured by the Hopkins Verbal Learning Test Revised - HVLT-R) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28., eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Connecticut Healthcare System, city: West Haven, state: Connecticut, zip: 06516, country: United States, contacts name: Jenelle Newcomb, BA, role: CONTACT, phone: 203-932-5711, phoneExt: 12874, email: jenelle.leblanc@yale.edu, contacts name: Ismene Petrakis, MD, role: CONTACT, phone: (203) 932-5711, phoneExt: 12244, email: ismene.petrakis@yale.edu, contacts name: Ismene Petrakis, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: John Krystal, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.27065, lon: -72.94705, hasResults: False