Phase 2 PTSD Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 55 years old
• You came to the emergency department (ED) within 72 hours of being in a motor vehicle crash (car accident)
• You are expected to be sent home from the ED (not admitted to the hospital)
• You are willing and able to follow all study requirements for the full duration of the study
• You agree to receive messages or communications that are not encrypted (not specially secured)
• You have a smartphone with an active service plan that you have had for at least 1 year
• You have a personal email address that you check regularly
• You can speak and read English
• Your pain level in the ED is at least 4 out of 10
• You either cannot become pregnant (for example, due to a hysterectomy, removal of both ovaries, or confirmed menopause for at least 12 months in a row), OR you are able to become pregnant but agree to use a highly effective form of birth control for the first 21 days of the study (such as hormonal methods, an IUD, or double barrier methods like condoms and a diaphragm)

Who may not be able to join:

• You have a serious additional injury from the crash, such as a broken bone in your arm or leg
• You are pregnant, breastfeeding, planning to become pregnant, or are able to become pregnant but are not using a reliable form of birth control
• You are currently incarcerated (in prison or jail)
• You were using opioid pain medications (such as oxycodone or morphine) every day before the crash
• You are currently experiencing psychosis, thoughts of harming yourself, or thoughts of harming others
• You are expected to be admitted to the hospital rather than going home
• You have a history of irregular heartbeat, heart block, problems with how your heart's electrical signals work, or heart failure
• You are currently recovering from a recent heart attack
• You have had a bad reaction or allergy to cyclobenzaprine or the ingredients in the study drug or placebo
• You have a history of difficulty urinating, a type of glaucoma called angle-closure glaucoma, increased pressure in your eyes, or an overactive thyroid gland
• You are currently taking, or have taken in the past 14 days, a type of medication called MAO inhibitors (a type of antidepressant), due to a risk of a dangerous drug interaction
• You are currently taking or plan to take certain medications during the study, including some antidepressants (SSRIs, SNRIs, tricyclics), certain pain medications (tramadol, meperidine), certain heart medications (verapamil, guanethidine), anticholinergic drugs, bupropion, muscle relaxants (long-term use), St. John's Wort, or certain other medications listed by the study team (confirm with trial site)
• You have significant liver or kidney problems, as measured by specific blood test results (confirm with trial site for exact values)
• You are currently unable to make your own decisions, for example because you have been given sedatives or sleeping medications
• You have any other condition or history that the study doctor believes would make it unlikely you could safely or properly participate in the study (confirm with trial site)
• Your blood pressure or heart rate is too high at the start of the study (specifically, top number of blood pressure 170 or above, bottom number 100 or above, or heart rate of 115 or above)
• Your ECG (a test that checks your heart's electrical activity) shows certain abnormal results at the start of the study (confirm with trial site for details)
• You have a substance use disorder, alcohol use disorder, bipolar disorder, or schizophrenia
• You have a history of severe or unexplained swelling in your mouth or throat

Important: Always verify eligibility with the trial site directly before applying.