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

Ki vehet részt

• ≥ 18 years and ≤ 55 years of age
• Presentation to ED and able to complete enrollment visit activities 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
• 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 28 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 diaphragms)

Ki nem vehet részt

• 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
• Any chronic daily opioid use prior to MVC
• 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, chronic use muscle relaxants or planned use after MCV or other prohibited concomitant medications listed in section 5.6. PI to assess individual cases where single dose of muscle relaxant is prescribed in ED for inclusion
• 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)
• In addition to the lab results in exclusion #13 above, exclude patients who report the following and or if the following are in medical records -; history of renal disease; history of urinary retention, angle-closure glaucoma, increased intraocular pressure, or hyperthyroidism
• As part of additional screening, exclude patients who answer yes to any of the questions listed below-; Have you ever been told that you have renal or kidney disease?; Have you ever been diagnosed with hyperthyroidism or active overactive thyroid?; Have ever been told that you have a liver disease or cirrhosis, or problems with your liver?
• Any history of seizure disorder
• 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
• Substance or alcohol use disorder, bipolar disorder, or schizophrenia
• History of severe or unexplained oral, or oropharyngeal swelling or edema
• History of presyncope or syncopal episodes
• Any hepatic impairment or renal disease (defined as AST OR ALT > 3 times the upper limit of normal) or renal disease (defined as GFR ≤ 80 mL/min)
• 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
• Substantial comorbid injury (e.g., long bone fracture)
• Prisoner status
• Active psychosis, suicidal ideation, or homicidal ideation
• Plans for hospital admission
• Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)