BXCL501 After Stress to Increase Recovery Success

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Apr 16, 2025

Keywords

ClinConnect Summary

The BXCL501 study, also known as the BASIS Trial, is looking at whether a medication called BXCL501 can help people recover from acute stress after a car accident. This medication is given as a film that dissolves under the tongue, and the trial will check if it helps reduce symptoms of acute stress reaction and post-traumatic stress disorder, as well as improve thinking and memory functions in those affected. The trial will involve about 100 participants who are 18 to 65 years old, have been to the emergency department (ED) within 24 hours of a motor vehicle collision, and are expected to go home after their visit. Participants will need to have a smartphone and an email address they check regularly.

During the study, selected individuals will receive the medication in the ED and take it home for two weeks. They will also be monitored over time with regular check-ups to see how they respond to the treatment, including any side effects they might experience. To join the trial, participants must not have serious health issues or be on certain medications that could interfere with the study. This trial is not currently recruiting, but it aims to understand better ways to help people who experience severe stress after accidents.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 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 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
• • 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)