Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)

Recruiting Phase 2 Interventional Study
Acute Stress Reaction Acute Stress Disorder Neurocognitive Function Post-traumatic Stress
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
180 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Other
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About This Trial
This study will examine the safety and efficacy of TNX-102 SL 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 Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a double-blind placebo-controlled randomized clinical trial (RCT) to …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years and ≤ 55 years of age 2. Presentation to ED within 72 hours of MVC 3. Anticipated to be discharged home from the ED 4. Stated willingness to comply with all study procedures and availability for the duration of the study 5. Consent to receive unencrypted communicat…
Contacts

Romina Soudavari

9843195030

romina_soudavari@med.unc.edu

CONTACT