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NCT06636786RECRUITINGIRB Ready

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

(OASIS)

Sponsored by University of North Carolina, Chapel Hill

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 180 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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).

Who Can Participate

Inclusion Criteria

โ‰ฅ 18 years and โ‰ค 55 years of age
Admitted to ED within 24 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 โ‰ฅ 1 year
Has a personal email address they regularly access
Able to speak and read English
PTS prediction tool risk score โ‰ฅ 16 in the ED
Pain severity in the ED โ‰ฅ 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 hormonal methods of contraception for at least one full menstrual cycle prior to

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

180 participants

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Age Range

18 Years - 55 Years

โšง

Gender

ALL

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Sponsor

University of North Carolina, Chapel Hill

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Indianapolis

Indiana

Location available
View Indianapolis location page
RECRUITING

Kansas City

Kansas

Location available
View Kansas City location page
RECRUITING

Worcester

Massachusetts

Location available
View Worcester location page
RECRUITING

St Louis

Missouri

Location available
View St Louis location page
RECRUITING

Providence

Rhode Island

Location available
View Providence location page
RECRUITING

Providence

Rhode Island

Location available
View Providence location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Post-traumatic Stress Treatment in Indianapolis?

Join others in Indiana exploring innovative treatment options through clinical research

Post-traumatic Stress Treatment Options in Indianapolis, Indiana

If you're searching for Post-traumatic Stress treatment in Indianapolis, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Indianapolis, Kansas City, Worcester and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Post-traumatic Stress. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Indiana
Now Enrolling
Up to 180 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Post-traumatic Stress?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Post-traumatic Stress

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Post-traumatic Stress Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06636786. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.