Study of TNX-102 SL for Acute Stress After Car Accidents
This study is looking at whether a medication called TNX-102 SL (cyclobenzaprine HCl sublingual tablets) can help prevent or reduce severe stress reactions and post-traumatic stress (PTSD) in people who have been in a car accident. You might be able to join if you are between 18 and 55 years old and come to the emergency department within 72 hours of a car accident. The study will compare TNX-102 SL to a placebo (an inactive pill) to see if it reduces acute stress disorder (ASD) symptoms and improves brain function. The main goal is to see how much your ASD score changes after 1 and 3 weeks. The current recruitment status is unclear.
- Study design
- This is a double-blind, placebo-controlled, randomized clinical trial, meaning neither you nor your doctor will know if you are receiving the active drug or a placebo. The study plans to enroll 180 participants.
- What's involved
- You would take TNX-102 SL or a placebo under your tongue in the emergency department and then every day at bedtime for a total of 2 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 the car 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.
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
At a glance
Conditions
Where it's being run
9 sites across 8 statesStudy leadership
- Samuel McLean, MD · PRINCIPAL_INVESTIGATOR · University of North Carollina at Chapel Hill
- Christopher Jones, MD · PRINCIPAL_INVESTIGATOR · Cooper University Health Care
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.