Actively Recruiting
Prevention and Reduction of Acute Stress Reactions and PTSD Using Sublingual Dexmedetomidine (BXCL501)
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-14
100
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of BXCL501, a sublingual film of dexmedetomidine hydrochloride, in reducing acute stress reaction (ASR) symptoms and behavioral changes in patients who visit the Emergency Department after a motor vehicle collision. The study focuses on high-risk individuals to see if this treatment can improve neurocognitive function and reduce posttraumatic stress symptoms over the long term. It involves a randomized, double-blind, placebo-controlled trial setting with 100 participants. Participants will receive either BXCL501 or a placebo, starting with an initial dose in the Emergency Department. Depending on timing, a second dose is taken either the same day or the following day at bedtime. After this, participants continue taking a dose each night before bedtime for 14 days. Both the active drug and placebo are administered sublingually (under the tongue). During the study, participants will undergo repeated assessments of psychological symptoms, neurocognitive function, and side effects at various times from minutes to weeks after the collision. Researchers will monitor changes in acute stress disorder symptoms, cognitive reaction times, pain, depressive symptoms, somatic symptoms, and posttraumatic stress symptoms. The study aims to track safety and effectiveness over this period, with a total participation duration covering the initial Emergency Department visit and 14 days of treatment.
CONDITIONS
Brief Title
BXCL501 After Stress to Increase Recovery Success
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Admitted to the Emergency Department within 72 hours of a motor vehicle collision
- Expected to be discharged home from the Emergency Department
- Willing to comply with all study procedures and available for the study duration
- Consent to receive unencrypted communications
- Owns a smartphone with continuous service for at least 1 year
- Has a personal email address regularly accessed
- Able to speak and read English
- Females of childbearing potential must use medically effective birth control for 3 months before and during the study
You will not qualify if you...
- Significant additional injuries such as long bone fractures
- Pregnant, breastfeeding, planning to become pregnant, or not using effective contraception if of childbearing potential
- Prisoner status
- Chronic daily opioid use above 20 mg oral morphine equivalents before the motor vehicle collision
- Diagnosis of bipolar disorder, psychotic disorder, active psychosis, suicidal or homicidal ideation
- Hospital admission required
- History of serious cardiac disease or abnormal heart function or rhythm
- Low magnesium or potassium levels
- Significant liver impairment or history of cirrhosis
- Taking certain medications including those for alcoholism, sedatives, alpha-2-adrenergic agonists, adrenergic agents, or QT prolonging drugs
- Allergic reaction history to dexmedetomidine
- Unable to provide informed consent
- Any condition that may interfere with study compliance or safety
- Participation in another pharmacological clinical trial within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) in the Emergency Department within 72 hours of a motor vehicle collision
Duration - 14 days
Participants take BXCL501 or placebo sublingually in the Emergency Department and then daily at bedtime for 14 days to reduce acute stress reaction symptoms.
1 initial dosing visit in the Emergency Department and daily self-administration at home for 14 days
Duration - Up to 12 weeks after treatment
Participants are monitored for changes in posttraumatic stress symptoms and cognitive function up to 12 weeks after treatment.
Regular assessments at multiple timepoints including Week 1, 3, 6, 8, 11, and 12 post motor vehicle collision
Trial Site Locations
Total: 3 locations
1
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
2
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Not Yet Recruiting
3
UVA University Hospital
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
R
Romina Soudavari, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here