Actively Recruiting
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-13
180
Participants Needed
9
Research Sites
75 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 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 determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats/reduces acute stress reaction (ASR)/acute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 180 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
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 55 years
- Presentation to the emergency department within 72 hours of a motor vehicle collision
- Expected to be discharged home from the emergency department
- Willingness to follow all study procedures and be available for the study duration
- Consent to receive unencrypted communications
- Possession of a smartphone with continuous service for at least one year
- Regular use of a personal email address
- Ability to speak and read English
- Pain severity of 4 or greater on a 0-10 scale in the emergency department
- Not of childbearing potential (e.g., hysterectomy, bilateral oophorectomy, or postmenopausal for at least 12 months)
- If able to conceive, agreement to use highly effective birth control during the first 21 days of participation
You will not qualify if you...
- Significant additional injuries such as long bone fractures
- Childbearing potential individuals who are pregnant, breastfeeding, planning pregnancy, or not using highly effective contraception
- Prisoners
- Chronic daily opioid use before the motor vehicle collision
- Active psychosis, suicidal or homicidal thoughts
- Planned hospital admission
- History of heart rhythm problems, heart failure, or heart conduction issues
- Currently recovering from a recent heart attack
- Allergy to cyclobenzaprine or ingredients in TNX-102 SL or placebo
- History of urinary retention, specific eye conditions, or hyperthyroidism
- Use of monoamine oxidase inhibitors within 14 days before participation
- Use of prohibited medications during the study, including certain antidepressants, muscle relaxants, or other specified drugs
- Liver or kidney disease as defined by specific laboratory values
- Inability to give informed consent due to sedative use
- Any other condition judged to interfere with participation or study safety
- Elevated blood pressure (systolic 170 mmHg or higher, diastolic 100 mmHg or higher) or heart rate above 115
- Abnormal baseline ECG findings such as prolonged QRS or QTc intervals, abnormal rhythm, or heart block
- Substance or alcohol use disorder, bipolar disorder, or schizophrenia
- History of severe or unexplained swelling of the mouth or throat
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Trial Site Locations
Total: 9 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
2
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
4
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Cooper University Health System
Camden, New Jersey, United States, 08103
Actively Recruiting
6
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
7
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
8
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
9
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Not Yet Recruiting
Research Team
R
Romina Soudavari
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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