Actively Recruiting
BXCL501 After Stress to Increase Recovery Success
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-14
100
Participants Needed
3
Research Sites
31 weeks
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 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.
CONDITIONS
Official 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 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
- Have a smartphone with continuous service for at least 1 year
- Have a personal email address regularly accessed
- Able to speak and read English
- Females of childbearing potential must be willing to use effective birth control for 3 months before and during the study
You will not qualify if you...
- Significant other injuries such as long bone fractures
- Pregnant, breastfeeding, planning pregnancy, or not using highly effective contraception if of childbearing potential
- Prisoner status
- Chronic daily opioid use before the motor vehicle collision exceeding 20 mg oral morphine equivalents
- Bipolar disorder, psychotic disorders, active psychosis, suicidal or homicidal thoughts
- Hospital admission
- Significant heart conditions or abnormal heart tests
- Low magnesium or potassium levels
- Severe liver problems
- Taking medications for alcoholism, sedative psychotropic drugs, alpha-2 adrenergic agonists, adrenergic agents like prazosin, or QT-prolonging drugs
- Allergic to dexmedetomidine
- Unable to give informed consent due to sedation
- Any condition that may interfere with study compliance or safety
- Participation in another drug trial within 30 days before screening
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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