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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)
Investigating the Effects of an Investigational Medication on Stress Responses After Motor Vehicle Collisions
P
Paul Musey, MD
Primary Investigator
Enrolling By Invitation
18 years - 55 years
All
Phase
N/A
36 participants needed
1 Location
Brief description of study
Primary To evaluate the safety and efficacy of TNX-102 SL to reduce acute stress reaction (ASR)/acute stress disorder (ASD) after a motor vehicle collision (MVC) Secondary To evaluate the efficacy of TNX-102 SL to improve neurocognitive function and prevent posttraumatic stress (PTS) symptoms after an MVC
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential research subjects will be pooled from those presenting to the emergency department (ED) within 24 hours of MVC with a PTS prediction tool risk score ≥16.
Detailed description of study
- Eligible patients who consent to participate in the study will: receive a blood draw to collect approximately 15 mL of blood (equivalent to about 1 tablespoon) to confirm eligibility and determine baseline blood values, be randomized in the ED, receive a half dose of the study drug (equivalent to 1 tablet) in the ED, and be discharged from the ED with a two-week supply of study drug.
- Prior to initial 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Post-Traumatic Stress Disorder, PTSD, Acute Stress Reaction, ASR
-
Age: 18 years - 55 years
-
Gender: All
Inclusion criteria
1. ≥ 18 years and ≤ 55 years of age
2. Admitted to ED within 24 hours of MVC
3. Anticipated to be discharged home from the ED
4. Stated willingness to comply with all study procedures and availability for the duration of the study
5. Has a smartphone with continuous service for ≥ 1 year
6. Has a personal email address they regularly access
7. Able to speak and read English
8. PTS prediction tool risk score ≥ 16 in the ED
9. Pain severity in the ED ≥ 4 (0-10 numeric rating scale)
10. People who are not of childbearing potential (e.g., hysterectomy, bilateral oophorectomy, or confirmed postmenopausal for at least last 12 consecutive months)
11. 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 diaphragms)
Exclusion criteria
1. Substantial comorbid injury (e.g., long bone fracture)
2. 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
3. Prisoner status
4. Chronic daily opioid use prior to MVC (>20 mg oral daily morphine equivalents)
5. Active psychosis, suicidal ideation, or homicidal ideation
6. Plans for hospital admission
7. History of arrhythmias, heart block or conduction disturbances, congestive heart failure
8. Currently in the acute recovery phase of myocardial infarction
9. Known hypersensitivity to cyclobenzaprine or the excipient in TNX-102 SL or placebo formulations
10. History of urinary retention, angle-closure glaucoma, increased intraocular pressure, or hyperthyroidism (known or identified in ED as TSH > 1.5 times the upper limit of normal)
11. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation due to risk of potential fatal drug-drug interactions
12. 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
13. Any hepatic impairment (defined as AST OR ALT > 3 times the upper limit of normal or renal disease (defined as GFR ≥ 80 mL/min)
14. Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)
15. 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)
16. Elevated baseline blood pressure defined as systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mmHg
17. Abnormal baseline ECG as defined as: QRS duration ≥ 120 ms; QTc value > 460 ms; not in sinus rhythm; or 1st, 2nd, or 3rd degree heart block indicated
18. Known substance or alcohol use disorder, bipolar disorder, or schizophrenia
1. ≥ 18 years and ≤ 55 years of age
2. Admitted to ED within 24 hours of MVC
3. Anticipated to be discharged home from the ED
4. Stated willingness to comply with all study procedures and availability for the duration of the study
5. Has a smartphone with continuous service for ≥ 1 year
6. Has a personal email address they regularly access
7. Able to speak and read English
8. PTS prediction tool risk score ≥ 16 in the ED
9. Pain severity in the ED ≥ 4 (0-10 numeric rating scale)
10. People who are not of childbearing potential (e.g., hysterectomy, bilateral oophorectomy, or confirmed postmenopausal for at least last 12 consecutive months)
11. 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 diaphragms)
Exclusion criteria
1. Substantial comorbid injury (e.g., long bone fracture)
2. 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
3. Prisoner status
4. Chronic daily opioid use prior to MVC (>20 mg oral daily morphine equivalents)
5. Active psychosis, suicidal ideation, or homicidal ideation
6. Plans for hospital admission
7. History of arrhythmias, heart block or conduction disturbances, congestive heart failure
8. Currently in the acute recovery phase of myocardial infarction
9. Known hypersensitivity to cyclobenzaprine or the excipient in TNX-102 SL or placebo formulations
10. History of urinary retention, angle-closure glaucoma, increased intraocular pressure, or hyperthyroidism (known or identified in ED as TSH > 1.5 times the upper limit of normal)
11. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation due to risk of potential fatal drug-drug interactions
12. 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
13. Any hepatic impairment (defined as AST OR ALT > 3 times the upper limit of normal or renal disease (defined as GFR ≥ 80 mL/min)
14. Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)
15. 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)
16. Elevated baseline blood pressure defined as systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mmHg
17. Abnormal baseline ECG as defined as: QRS duration ≥ 120 ms; QTc value > 460 ms; not in sinus rhythm; or 1st, 2nd, or 3rd degree heart block indicated
18. Known substance or alcohol use disorder, bipolar disorder, or schizophrenia
Updated on
23 Jun 2025.
Study ID: EMER-UNC-OASIS, 23388
This study investigates the effects of an investigational medication on reducing acute stress reactions and acute stress disorder following a motor vehicle collision. Acute stress reactions are immediate psychological responses to a traumatic event, which can develop into acute stress disorder if symptoms persist. The purpose of this study is to evaluate both the safety and effectiveness of the investigational medication in managing these conditions and to assess its impact on neurocognitive function and the prevention of posttraumatic stress symptoms.
Participants in the study will undergo several procedures. After consenting, they will have a blood sample taken to confirm eligibility and establish baseline values. Participants will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. They will then be monitored through assessments of psychological and somatic symptoms, neurocognitive function, and any adverse events over time.
- Who can participate: Participants must be between 18 and 55 years old and admitted to the emergency department within 24 hours of a motor vehicle collision. They should have a smartphone and email access, be able to speak and read English, and meet specific health criteria including a PTS risk score of 16 or higher.
- Study details: Participants will take the investigational medication or a placebo, an inactive substance resembling the investigational medication. They will attend regular assessments to monitor their symptoms and provide feedback on their condition throughout the study duration.
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