Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With a Sublingual Formulation of Dexmedetomidine (BXCL501)
University of North Carolina, Chapel Hill
Summary
This study will examine the safety and efficacy of BXCL501 to reduce ASR symptoms and behavioral changes among patients presenting to the Emergency Department (ED) after Motor Vehicle Collision (MVC). Specifically, the investigators will perform the BXCL501 (BASIS) Trial, a double-blind placebo-controlled Randomized Controlled Trial (RCT) to determine if BXCL501 (dexmedetomidine hydrochloride sublingual film) initiated in the ED in the hours after MVC to high risk individuals, treats/reduces ASR/ASD symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 100 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.
Description
U.S. military personnel are exposed to life-threatening traumatic events (e.g., intense firefights with multiple casualties) that result in acute stress reaction (ASR) symptoms (ICD-10) and posttraumatic stress (PTS). Similarly, acute and persistent stress symptoms, and related adverse posttraumatic neuropsychiatric sequelae, are also very common and cause a tremendous burden of suffering in civilian populations following exposure to life-threatening traumatic events (e.g., motor vehicle collision, violent or accidental death of a loved one, and assault). BXCL501 (dexmedetomidine HCl sublingua…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥ 18 years and ≤ 65 years of age 2. Admitted to ED within 72 hours of MVC 3. Anticipated to be discharged home from the ED 4. Stated willingness to comply with all study procedures and availability for the duration of the study 5. Consent to receive unencrypted communications 6. Has a smartphone with continuous service for ≥ 1 year 7. Has a personal email address they regularly access 8. Able to speak and read English 9. Females of childbearing potential (not surgically sterilized (tubal ligation/hysterectomy) or not post-menopausal (no menstrual period for \> 12 months…
Interventions
- DrugBXCL501 (dexmedetomidine HCl)
BXCL501 (dexmedetomidine HCl) taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.
- DrugPlacebo
Placebo taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.
Locations (3)
- University of Florida College of Medicine - JacksonvilleJacksonville, Florida
- Washington University in St. LouisSt Louis, Missouri
- UVA University HospitalCharlottesville, Virginia