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.
BXCL501 After Stress to Increase Recovery Success
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Samuel McLean, MD · PRINCIPAL_INVESTIGATOR · University of North Carollina at Chapel Hill
- Stacey House, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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What this trial measures
- 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.