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Prevention study for Acute Stress Reaction
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 Cyclobenzaprine HCl?
Cyclobenzaprine HCl is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute stress reaction.
Also referred to as TNX-102 SL.
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 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.
- 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 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 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 21 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.