Acute Stress ReactionPhase 2OASISNCT06636786
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
A Phase 2 study testing Cyclobenzaprine HCl in people with Acute Stress Reaction and Acute Stress Disorder, run by University of North Carolina, Chapel Hill at 9 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Stress Reaction, Acute Stress Disorder, Neurocognitive Function
- What is being tested?
- Cyclobenzaprine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Mar 2025to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥ 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Show all 28Show fewer
- 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, 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
- 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 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
- History of presyncope or syncopal episodes
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Whitney Taylor
Lauren Walter
- Recruiting
Cooper University Health System
Camden, New Jersey, 08103
Dylan Kurowsky
Christopher Jones
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Hawa Sall
Michael Lyons
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Leah Emmons, 463 274 2373, ldemmons@iu.edu
Paul Musey, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Lucas Lemar, 913-588-3580, llemar@kumc.edu
Lindsay Maguire, MD
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Carolyn Ortega, 401-444-6619, cortega@lifespan.org
Sarah Tokarz, 401-606-9815, stokarz1@lifespan.org
- Recruiting
The Miriam Hospital
Providence, Rhode Island, 02903
Carolyn Ortega, 401-444-6619, cortega@lifespan.org
Adam Aluisio, MD
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Stephanie Perez
Ralph Riviello
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Jamie Mills, 314-273-1382, jamiem@wustl.edu
Stacey House, MD
About this study
Official title: 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)
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.
Read the detailed description
U.S. military personnel are exposed to life-threatening traumatic events (e.g., intense firefights with multiple casualties) that result in acute stress reaction (ASR) symptoms (ICD-10) and posttraumatic stress (PTS). Similarly, acute and persistent stress symptoms, and related adverse posttraumatic neuropsychiatric sequelae, are also very common and cause a tremendous burden of suffering in civilian populations following exposure to life-threatening traumatic events (e.g., motor vehicle collision, violent or accidental death of a loved one, and assault). TNX-102 SL (cyclobenzaprine HCl sublingual tablet) is being developed for the management of fibromyalgia (FM), and post-traumatic stress disorder (PTSD) by Tonix Pharmaceuticals, Inc; the FM program is in mid-Phase 3 development and PTSD is Phase 3 ready. In previous PTSD and fibromyalgia studies, TNX-102 SL has demonstrated the ability to improve sleep quality, which, based on published clinical studies of fear memory and stress responsiveness, has been shown to play a significant role in stress recovery. To date, TNX-102 SL has undergone an intense nonclinical and clinical development including Phase 1, 2, and 3 studies that assessed safety in over 1,180 subjects. TNX-102 SL is an extremely promising agent to reduce ASR symptoms and related behavioral changes, to enhance resilience and improve warfighter performance, and to reduce the frequency and severity of persistent/chronic PTS symptoms. The results of this study will ultimately provide military personnel, veterans, and civilians with an important new treatment option that, when administered in the early aftermath of traumatic stress exposure, can improve recovery, job performance, and quality of life.
- Conditions
- Acute Stress Reaction, Acute Stress Disorder, Neurocognitive Function, Post-traumatic Stress
- Being tested
- Cyclobenzaprine HCl, Placebo
- Medical subject headings
- Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclobenzaprine HClDrug
Also called TNX-102 SL
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks.
PlaceboDrug
Also called Sugar pill
Placebo sublingual tablets taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cyclobenzaprine HCl | Experimental | Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of Cyclobenzaprine HCl in the ED as part of enrollment procedures. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation. Receives: Drug: Cyclobenzaprine HCl |
| Placebo | Placebo comparator | Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of placebo in the ED as part of enrollment procedures. The placebo is the same formulation as active except the Cyclobenzaprine HCl content is replaced by Mannitol to maintain the same tablet weight and dimensions. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ASD Score
Individuals are asked to complete the 14-item Acute Stress Disorder Scale (ASDS) self-report inventory where each item is rated on a 5-point scale (0= Not at all; 1= Mildly; 2= Medium; 3= Quite a bit; 4= Very Much) that indexes acute stress disorder (ASD). Range of possible total scores is 0-56, with higher total scores indicating greater acute stress symptoms.
Measured: Week 1, 3 after MVC
Secondary outcomes (8)
Median reaction time of correct responses (general cognitive function)
General cognitive function will be assessed using the Test My Brain Digit Symbol Matching Test. Participants will be asked to match symbols and numbers using a symbol-number key shown on screen. General cognitive function is assessed via measuring median reaction time of correct responses (medianRTc) to 'test' trials. Range for medianRTc (ms) is 0-30000.
Measured: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Median reaction time of correct responses (procedural reaction time)
Procedural reaction time will be assessed using the Test My Brain Choice Reaction Time Test. Participants see a set of three arrows, where one arrow is a different color from the rest. The participant presses left or right to indicate the direction of the odd colored arrow. Reaction time is assessed via measuring median reaction time of correct responses (medianRTc) to 'test' trials. Range for medianRTc (ms) is 0-5000.
Measured: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Proportion of targets correctly identified (visuospatial processing and attention)
Visuospatial processing and attention will be assessed using the Test My Brain Multiple Object Tracking Test. In this test of visuospatial processing and attention, participants have to track a set of target circles around the screen (amidst a field of distractors) that move at increasing speed with each trial. Once the circles stop moving, participants select which were targets must identify targets instead of distractors. Visuospatial processing and attention are assessed via the proportion of targets correctly identified. Range for measure is 0-1.
Measured: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
d-prime identification (psychomotor vigilance)
Psychomotor vigilance will be assessed via the Test My Brain Gradual Onset Continuous Performance Test. In this task, participants monitor a stream of city and mountain images that rapidly fade from one to the next with no interstimulus interval. Participants are asked to press/touch for each city image and to withhold for each mountain image. Vigilance is assessed via measuring d-prime for identification of each city image, a signal detection-based measure that takes into account both hits and false alarms to provide an unbiased estimate of performance where higher values reflect better performance. Response inhibition is defined as the suppression of actions that are inappropriate in a given context. Response inhibition is assessed using results from the above, by measuring the number of commission errors (failure to withhold responses) where most positive scores reflect more impulsive responding. Range for measure is -4.2279 - 4.2279.
Measured: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Change in Pain Symptom Score
The Regional Pain Scale (RPS) will be used to assess the extent of body pain. 13 items will be scored on a 0-10 pain scale where 0 is no pain and 10 is severe pain. Range of possible total scores is 0-130, with higher total scores indicative of greater pain symptoms
Measured: Baseline, Week 1, 3, 6, 12 after MVC
Change in Depressive Symptoms Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8b; an 8-item scale, and one question from the PROMIS Depression Item Bank will be aggregated/combined to assess depression. Each item is scored on a 5-point scale where 0 is "none of the time" and 5 means "all or almost all of the time". Range of possible total scores is 0-45, with higher total scores indicative of greater depressive symptoms.
Measured: Baseline, Week 1, 3, 6, 12 after MVC
Change in Somatic Symptom Score
The Pennebaker Inventory of Limbic Languidness (PILL) assesses the frequency of common physical symptoms and sensations. We will use a version with adapted response options for greater consistency across measures, greater precision in response levels, and to allow administration via self-report. 20 items will be scored on a 0-10 scale where 0 is "no problem" and 10 means "major problem". Range of possible total scores is 0-200, with higher total scores indicative of greater somatic symptoms.
Measured: Baseline, Week 1, 3, 6, 12 after MVC
Change in PTSD Symptoms
The PTSD Checklist for DSM-5 (PCL-5) assesses PTSD symptoms as defined by the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5). 20 items will be scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Range of possible total scores is 0-80, with higher total scores indicative of greater PTSD symptoms.
Measured: Baseline, Week 1, 3, 6, 12 after MVC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start25 Mar 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress ReactionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Tonix Pharmaceuticals, Inc., Mclean Hospital, Cooper University Health Care
- Responsible party
- Sponsor
- Investigators
- Samuel McLean, MD, Principal investigator, University of North Carollina at Chapel HillChristopher Jones, MD, Principal investigator, Cooper University Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636786
- Sponsor's protocol ID
- 23-0711
- Acronym
- OASIS
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06636786
- Acronym / sponsor ID
- OASIS / 23-0711
- Conditions
- Acute Stress Reaction, Acute Stress Disorder, Neurocognitive Function, Post-traumatic Stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- United States Department of Defense, Tonix Pharmaceuticals, Inc., Mclean Hospital, Cooper University Health Care
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
U.S. military personnel are exposed to life-threatening traumatic events (e.g., intense firefights with multiple casualties) that result in acute stress reaction (ASR) symptoms (ICD-10) and posttraumatic stress (PTS). Similarly, acute and persistent stress symptoms, and related adverse posttraumatic neuropsychiatric sequelae, are also very common and cause a tremendous burden of suffering in civilian populations following exposure to life-threatening traumatic events (e.g., motor vehicle collision, violent or accidental death of a loved one, and assault). TNX-102 SL (cyclobenzaprine HCl sublingual tablet) is being developed for the management of fibromyalgia (FM), and post-traumatic stress disorder (PTSD) by Tonix Pharmaceuticals, Inc; the FM program is in mid-Phase 3 development and PTSD is Phase 3 ready. In previous PTSD and fibromyalgia studies, TNX-102 SL has demonstrated the ability to improve sleep quality, which, based on published clinical studies of fear memory and stress responsiveness, has been shown to play a significant role in stress recovery. To date, TNX-102 SL has undergone an intense nonclinical and clinical development including Phase 1, 2, and 3 studies that assessed safety in over 1,180 subjects. TNX-102 SL is an extremely promising agent to reduce ASR symptoms and related behavioral changes, to enhance resilience and improve warfighter performance, and to reduce the frequency and severity of persistent/chronic PTS symptoms. The results of this study will ultimately provide military personnel, veterans, and civilians with an important new treatment option that, when administered in the early aftermath of traumatic stress exposure, can improve recovery, job performance, and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclobenzaprine HCl | Experimental | Drug: Cyclobenzaprine HClParticipants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of Cyclobenzaprine HCl in the ED as part of enrollment procedures. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of placebo in the ED as part of enrollment procedures. The placebo is the same formulation as active except the Cyclobenzaprine HCl content is replaced by Mannitol to maintain the same tablet weight and dimensions. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- ≥ 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclobenzaprine HClAlso: TNX-102 SLTNX-102 SL (cyclobenzaprine HCl sublingual tablets) taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks. | Drug | Cyclobenzaprine HCl |
| PlaceboAlso: Sugar pillPlacebo sublingual tablets taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks. | Drug | Placebo |
Primary outcome
Change in ASD Score
Time frame: Week 1, 3 after MVC
Individuals are asked to complete the 14-item Acute Stress Disorder Scale (ASDS) self-report inventory where each item is rated on a 5-point scale (0= Not at all; 1= Mildly; 2= Medium; 3= Quite a bit; 4= Very Much) that indexes acute stress disorder (ASD). Range of possible total scores is 0-56, with higher total scores indicating greater acute stress symptoms.
8 secondary outcomes
Median reaction time of correct responses (general cognitive function)
Time frame: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Median reaction time of correct responses (procedural reaction time)
Time frame: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Proportion of targets correctly identified (visuospatial processing and attention)
Time frame: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
d-prime identification (psychomotor vigilance)
Time frame: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Change in Pain Symptom Score
Time frame: Baseline, Week 1, 3, 6, 12 after MVC
Change in Depressive Symptoms Score
Time frame: Baseline, Week 1, 3, 6, 12 after MVC
Change in Somatic Symptom Score
Time frame: Baseline, Week 1, 3, 6, 12 after MVC
Change in PTSD Symptoms
Time frame: Baseline, Week 1, 3, 6, 12 after MVC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Related trials for Acute Stress Reaction
Not yet recruiting
Acute Effect of Aerobic Exercise on Cardiovascular Reactivity During a Mental Stress Test in Teachers
Behavior
RecruitingPhase 1
Acute Effects of Cannabis on Cognition and Affect
Cannabis Use
Not yet recruiting
Assessment of the Preventive Effect of Defusing on Traumatic Kindling
Acute Stress Disorder, Post Traumatic Stress Disorder PTSD
Recruiting
Integrative Medicine for Hospital Workers Exposed to War
Anxiety
Recruiting
The Efficacy of Vitamin D Supplementation to Sustain Performance Outcomes
Acute Stress Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel McLean, MD principal investigator
University of North Carollina at Chapel Hill
Christopher Jones, MD principal investigator
Cooper University Health Care
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclobenzaprine HCl in people with Acute Stress Reaction and Acute Stress Disorder, run by University of North Carolina, Chapel Hill at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romina Soudavari (9843195030, romina_soudavari@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ASD Score (time frame: Week 1, 3 after MVC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.