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 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 criteria
Qualifiers
≥ 18 years and ≤ 55 years of age
Presentation to ED within 72 hours of MVC
Anticipated to be discharged home from the ED
Stated willingness to comply with all study procedures and availability for the duration of the study
Disqualifiers
Substantial comorbid injury (e.g., long bone fracture)
People of childbearing potential who are pregnant, breastfeeding, planning to become pregnant, or not using a highly effective form of contraception (e.g., implants, intrauterine devices (IUDs), tubal ligation, hormonal birth control pills, patches, vaginal rings, or injections) during their participation
Prisoner status
Any chronic daily opioid use prior to MVC
Trial design
Treatments tested in this trial
- Cyclobenzaprine HCl
- Placebo
Treatment groups
Sponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
United States Department of Defense
Collaborator
Tonix Pharmaceuticals, Inc.
Collaborator
Mclean Hospital
Collaborator
Cooper University Health Care
Collaborator