RECRUITING

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

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Conditions

Acute Stress ReactionAcute Stress DisorderNeurocognitive FunctionPost-traumatic Stress

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2025-03-25
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06636786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion 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. * Consent to receive unencrypted communications
  6. * Has a smartphone with continuous service for ≥ 1 year
  7. * Has a personal email address they regularly access
  8. * Able to speak and read English
  9. * PTS prediction tool risk score ≥ 16 in the ED
  10. * Pain severity in the ED ≥ 4 (0-10 numeric rating scale)
  11. * People who are not of childbearing potential (e.g., hysterectomy, bilateral oophorectomy, or confirmed postmenopausal for at least last 12 consecutive months)
  12. * 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 diaphrams)
  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. * Any chronic daily opioid use prior to MVC
  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. * 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 (TSH \< lower 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 of protocol
  13. * Any hepatic impairment or renal disease (defined as aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal) or renal disease (defined as glomerular filtration rate (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 and or elevated heart rate of ≥115
  17. * 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
  18. * Substance or alcohol use disorder, bipolar disorder, or schizophrenia
  19. * History of severe or unexplained oral, or oropharyngeal swelling or edema

Contacts and Locations

Study Contact

Romina Soudavari
CONTACT
9843195030
romina_soudavari@med.unc.edu

Principal Investigator

Samuel McLean, MD
PRINCIPAL_INVESTIGATOR
University of North Carollina at Chapel Hill
Christopher Jones, MD
PRINCIPAL_INVESTIGATOR
Cooper University Health Care

Study Locations (Sites)

Indiana University
Indianapolis, Indiana, 46202
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Massachusetts Chan Medical School (Umass Memorial Medical Center)
Worcester, Massachusetts, 01655
United States
Washington University in St. Louis
Saint Louis, Missouri, 63110
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
The Miriam Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Samuel McLean, MD, PRINCIPAL_INVESTIGATOR, University of North Carollina at Chapel Hill
  • Christopher Jones, MD, PRINCIPAL_INVESTIGATOR, Cooper University Health Care

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25
Study Completion Date2025-09

Study Record Updates

Study Start Date2025-03-25
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Stress Reaction
  • Acute Stress Disorder
  • Neurocognitive Function
  • Post-traumatic Stress