Acute Stress Reaction study: Cyclobenzaprine HCl
Official title Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
ClinicalTrials.gov ID: NCT06636786
What this study is testing
What is TNX-102 SL?
An investigational sublingual tablet being studied for treating acute stress reaction after a motor vehicle collision.
Also referred to as cyclobenzaprine HCl.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether TNX-102 SL started in the emergency department after a car crash can reduce stress symptoms and improve thinking. It also looks at whether it helps prevent later trauma symptoms.
- Who it's for
- You may be able to join if you were in a serious car crash and were taken to the emergency department for treatment.
- What's involved
- You will take a small pill under your tongue in the emergency department and then keep a supply for two weeks. You will have several check‑ins to report how you feel and to do simple thinking tests.
- Time commitment
- The study lasts about two weeks, with visits in the emergency department and follow‑up check‑ins over that period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- ≥ 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
You likely can't join if
- 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...
- Prisoner status
- Any chronic daily opioid use prior to MVC
- Active psychosis, suicidal ideation, or homicidal ideation
- Plans for hospital admission
See the full eligibility criteria
- ≥ 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...
- 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...
- 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...
- 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)
- 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
- 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...
- 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
- History of presyncope or syncopal episodes
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- St Louis, Missouri, United States
- Camden, New Jersey, United States
- Columbus, Ohio, United States
- Providence, Rhode Island, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Indianapolis, Indiana, United States; Kansas City, Kansas, United States; St Louis, Missouri, United States; Camden, New Jersey, United States; Columbus, Ohio, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.