About this trial
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.
Eligibility criteria
Qualifiers
≥ 18 years and ≤ 65 years of age
Admitted to ED within 72 hours of MVC
Anticipated to be discharged home from the ED
Stated willingness to comply with all study procedures and availability for the duration of the study
Disqualifiers
Substantial comorbid injury (e.g., long bone fracture)
People of childbearing potential who are pregnant, breastfeeding, planning to become pregnant, or not using a highly effective form of contraception (e.g., implants, intrauterine devices (IUDs), tubal ligation, hormonal birth control pills, patches, vaginal rings, or injections) during their participation
Prisoner status
Chronic daily opioid use prior to MVC (> 20 mg oral daily morphine equivalents)
Trial design
Treatments tested in this trial
- BXCL501 (dexmedetomidine HCl)
- Placebo
Treatment groups
Sponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
United States Department of Defense
Collaborator
Mclean Hospital
Collaborator
Washington University School of Medicine
Collaborator
University of Florida
Collaborator
Rhode Island Hospital
Collaborator
Vanderbilt University School of Medicine
Collaborator
Walter Reed Army Institute of Research (WRAIR)
Collaborator