RecruitingPhase 2NCT06636786

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

Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) - (Optimizing Acute Stress Reaction Interventions With TNX-102 SL - OASIS)


Sponsor

University of North Carolina, Chapel Hill

Enrollment

180 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether sublingual cyclobenzaprine (a muscle relaxant placed under the tongue) can prevent or reduce acute stress reactions and PTSD symptoms in people who have just been in a car accident. It is given in the emergency room shortly after the accident. **You may be eligible if...** - You are 18–55 years old and came to the emergency room within 24 hours of a car accident - You are expected to be discharged home (not admitted to the hospital) - You have a moderate-to-high risk score for developing PTSD after the accident - You have significant pain (4 or higher on a 0–10 scale) - You have a smartphone and personal email address - You are able to use effective contraception if you could become pregnant **You may NOT be eligible if...** - You have a major injury such as a broken bone - You are pregnant or breastfeeding - You are a prisoner - You take daily opioid medications - You have active psychosis or suicidal thoughts - You have a heart condition (arrhythmia, heart failure, recent heart attack) - You have a known allergy to cyclobenzaprine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclobenzaprine HCl

TNX-102 SL (cyclobenzaprine HCl sublingual tablets) taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks.

DRUGPlacebo

Placebo sublingual tablets taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks.


Locations(9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Indiana University

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Washington University in St. Louis

St Louis, Missouri, United States

Cooper University Health System

Camden, New Jersey, United States

The Ohio State University

Columbus, Ohio, United States

Rhode Island Hospital

Providence, Rhode Island, United States

The Miriam Hospital

Providence, Rhode Island, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06636786


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