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

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial, called the OASIS Trial, is studying a medication called TNX-102 SL to see if it can help people who have experienced a motor vehicle accident (MVC) and are showing signs of acute stress reactions (ASR), which can include feelings of anxiety and distress. The researchers want to find out if taking this medication shortly after the accident can reduce ASR symptoms and improve mental function over time, as well as help prevent long-term issues like post-traumatic stress disorder (PTSD). The trial is looking for adults aged 18 to 55 who came to the emergency department within 24 hours of their accident and are at risk for developing PTSD.

Participants in the trial will receive either the study medication or a placebo (which looks like the medication but has no active ingredients) while in the emergency department, and will take the medication for two weeks after going home. Throughout the study, participants will be asked about their symptoms and overall well-being. It’s important to know that certain health conditions and medications may exclude someone from participating, so researchers will review these details with potential participants before enrolling them in the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 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 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
• • 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