Is NCT06636786 recruiting in Birmingham, AL?

Yes, NCT06636786 is currently recruiting participants at its Birmingham, AL location. This post-traumatic stress clinical trial is actively enrolling qualified participants.

How do I join the post-traumatic stress clinical trial in Birmingham?

To join this clinical trial in Birmingham, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Birmingham clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Post-traumatic Stress Clinical Trial in Birmingham, AL

About This Post-traumatic Stress Study in Birmingham

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/

Sponsor: University of North Carolina, Chapel Hill

Who Can Participate

Inclusion Criteria

≥ 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

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)

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Birmingham?

Yes, this clinical trial (NCT06636786) has an active research site in Birmingham, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Post-traumatic Stress Treatment Options in Birmingham, AL

If you're searching for post-traumatic stress treatment options in Birmingham, AL, this clinical trial (NCT06636786) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Birmingham research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced post-traumatic stress specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all post-traumatic stress clinical trials near you to find additional studies recruiting in your area.

Post-traumatic Stress Clinical Trial in Birmingham, AL

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