BXCL501 for Acute Stress After a Motor Vehicle Accident

This study is looking at whether a drug called BXCL501 (dexmedetomidine HCl) can help people recover better after experiencing a motor vehicle accident (MVC). Researchers want to see if taking BXCL501 under the tongue in the emergency department (ED) and at bedtime for two weeks can reduce symptoms of acute stress reaction (ASR), acute stress disorder (ASD), and post-traumatic stress disorder (PTSD). You might be able to join if you are 18-65 years old, were admitted to the ED within 72 hours of an MVC, and are expected to go home from the ED. The main goal is to see if BXCL501 changes your ASD score, measured at Week 1 and Week 3 after the MVC. The study plans to enroll 100 participants.

Study design
This is a double-blind, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving BXCL501 or a placebo (an inactive substance). 100 participants will be randomly assigned to one of these groups.
What's involved
You would take BXCL501 or placebo under your tongue in the ED and at bedtime for two weeks. You would also need to be available for the duration of the study and have a smartphone with continuous service.
Compensation
Not stated in the trial record.
Follow-up
Your ASD score will be measured at Week 1 and Week 3 after your motor vehicle accident.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06943404

BXCL501 After Stress to Increase Recovery Success

Recruiting
PHASE2Ages 18–65InterventionalPrevention
University of North Carolina, Chapel Hill
~100 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:BXCL501 (dexmedetomidine HCl)Placebo

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ASD Score
Measured over Week 1, 3 after MVC
Acute Stress Reaction
Acute Stress Disorder
Post-traumatic Stress Disorder
3 sites across 3 states
Florida1
Missouri1
Virginia1
  • Samuel McLean, MD · PRINCIPAL_INVESTIGATOR · University of North Carollina at Chapel Hill
  • Stacey House, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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  • Change in ASD ScoreWeek 1, 3 after MVC

    Individuals are asked to complete the 14-item Acute Stress Disorder Scale (ASDS) self-report inventory where each item is rated on a 5-point scale (0= Not at all; 1= Mildly; 2= Medium; 3= Quite a bit; 4= Very Much) that indexes acute stress disorder (ASD). Range of possible total scores is 0-56, with higher total scores indicating greater acute stress symptoms.