Condition: Acute Stress Reaction · Acute Stress Disorder · Post-traumatic Stress Disorder · Sponsor: University of North Carolina, Chapel Hill
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.
This description comes directly from the study's public registry record.
Romina Soudavari, MPH · 9843195030 · romina_soudavari@med.unc.edu
Always discuss trial participation with your own doctor first.
| University of Florida College of Medicine - Jacksonville | Jacksonville, Florida, United States | Recruiting |
| Washington University in St. Louis | St Louis, Missouri, United States | Not Yet Recruiting |
| UVA University Hospital | Charlottesville, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06943404