Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzap… (NCT06636786) | Clinical Trial Compass
RecruitingPhase 2
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
United States180 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. ≥ 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
✓. Consent to receive unencrypted communications
✓. Has a smartphone with continuous service for ≥ 1 year
✓. Has a personal email address they regularly access
✓. Able to speak and read English
Exclusion criteria
✕. 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