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

Neurocognitive Function Post-traumatic Stress Acute Stress Disorder Acute Stress Reaction

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

Inclusion Criteria12

≥ 18 years and ≤ 55 years of age
Admitted to ED within 24 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
PTS prediction tool risk score ≥ 16 in the ED
Pain severity in the ED ≥ 4 (0-10 numeric rating scale)
People who are not of childbearing potential (e.g., hysterectomy, bilateral oophorectomy, or confirmed postmenopausal for at least last 12 consecutive months)
People with the capacity to conceive a pregnancy must agree to employ a highly effective form of birth control throughout the first 21 days of study participation (e.g., oral, injected, transdermal, or implanted hormonal methods of contraception for at least one full menstrual cycle prior to study drug administration; placement of an intrauterine device (IUD) or intrauterine system (IUS); or double barrier methods such as condoms and diaphrams)

Exclusion Criteria19

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
Active psychosis, suicidal ideation, or homicidal ideation
Plans for hospital admission
History of arrhythmias, heart block or conduction disturbances, congestive heart failure
Currently in the acute recovery phase of myocardial infarction
Hypersensitivity to cyclobenzaprine or the excipient in TNX-102 SL or placebo formulations
History of urinary retention, angle-closure glaucoma, increased intraocular pressure, or hyperthyroidism (TSH \< lower limit of normal)
Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation due to risk of potential fatal drug-drug interactions
Current or planned use of the following prohibited concomitant medications during study participation: anticholinergic medications, guanethidine, selective serotonin reuptake inhibitors (SSRIs) , serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, MAO inhibitors, anticholinergic medications, guanethidine, potent cytochrome P450 subtype 3A4 inhibitor, St. John's wort, or other prohibited concomitant medications listed in section 5.6 of protocol
Any hepatic impairment or renal disease (defined as aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal) or renal disease (defined as glomerular filtration rate (GFR) ≤ 80 mL/min)
Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)
Any other history or condition that would, in the site investigator's judgement, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger patient)
Elevated baseline blood pressure defined as systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mmHg and or elevated heart rate of ≥115
Abnormal baseline ECG as defined as: QRS duration ≥ 120 ms; QTc \> 460 ms; not in sinus rhythm; or 1st, 2nd, or 3rd degree heart block indicated
Substance or alcohol use disorder, bipolar disorder, or schizophrenia
History of severe or unexplained oral, or oropharyngeal swelling or edema