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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of North Carolina, Chapel Hill

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

180 Participants
are divided into 2 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