Status:
NOT_YET_RECRUITING
BXCL501 After Stress to Increase Recovery Success
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
United States Department of Defense
Mclean Hospital
Conditions:
Acute Stress Reaction
Acute Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will examine the safety and efficacy of BXCL501 to reduce ASR symptoms and behavioral changes among patients presenting to the Emergency Department (ED) after Motor Vehicle Collision (MVC)....
Detailed Description
U.S. military personnel are exposed to life-threatening traumatic events (e.g., intense firefights with multiple casualties) that result in acute stress reaction (ASR) symptoms (ICD-10) and posttrauma...
Eligibility Criteria
Inclusion
- ≥ 18 years and ≤ 65 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 ≥ 1 year
- Has a personal email address they regularly access
- Able to speak and read English
- PTS prediction tool risk score ≥ 16 in the ED
- Females of childbearing potential (not surgically sterilized (tubal ligation/hysterectomy) or not post-menopausal (no menstrual period for \> 6 months)) must be willing to use a medically acceptable and effective birth control method for 3 months before the study and while participating in the study. Medically acceptable methods of contraception that may be used by the participant include abstinence, birth control pills or patches, birth control implants, diaphragm, intrauterine device (IUD), or condoms.
Exclusion
- 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
- Chronic daily opioid use prior to MVC (\> 20 mg oral daily morphine equivalents)
- Bipolar disorder, psychotic disorder, active psychosis, suicidal ideation, or homicidal ideation
- Plans for hospital admission
- Clinically significant history of cardiac disease including (a) history of syncope or other syncopal attacks; (b) current evidence of orthostatic hypotension (defined as a decrease in systolic BP of 20 mm Hg or decrease in diastolic BP of 10 mm Hg within 3 minutes); (c) resting heart rate of \<55 beats per minute; (d) systolic blood pressure \<110 mm Hg or diastolic BP \<70 mm Hg; (e) participants with a corrected QT interval (QTc) interval \>440msec (males) or \>460msec (females) not in sinus rhythm; or 1st, 2nd or 3rd degree hearth block; or (f) history of severely impaired ventricular function (ejection fraction \< 30%).
- Hypomagnesia (\<1.7 mg/dL) or hypokalemia (\< 3.0 Milliequivalents (mEq/L))
- Substantial hepatic impairment (e.g. Aspartate Transaminase (AST) or Alanine Transaminase (ALT) \> 3 times the upper limit of normal or history of cirrhosis).
- Currently taking the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation including sedative/hypnotics, barbiturates, antihistamines, sedative antidepressants (e.g. doxepin, mirtazapine, trazodone), and triptans (e.g., sumatriptan); c) alpha-2-adrenergic agonists (clonidine, guanfacine, lofexidine); d) or adrenergic agents prescribed for other reasons (prazosin). (Permitted Concomitant Medications: The concomitant medications allowed in the study include non-sedative antidepressants used to treat PTSD)
- Hypersensitivity or history of allergic reaction to dexmedetomidine
- Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)
Key Trial Info
Start Date :
August 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06943404
Start Date
August 29 2025
End Date
September 29 2026
Last Update
July 28 2025
Active Locations (5)
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1
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, United States, 32209
2
Washington University in St. Louis
St Louis, Missouri, United States, 63110
3
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
4
The Miriam Hospital
Providence, Rhode Island, United States, 02906