BXCL501 After Stress to Increase Recovery Success (NCT06943404) | Clinical Trial Compass
RecruitingPhase 2
BXCL501 After Stress to Increase Recovery Success
United States100 participantsStarted 2026-02-23
Plain-language 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). Specifically, the investigators will perform the BXCL501 (BASIS) Trial, a double-blind placebo-controlled Randomized Controlled Trial (RCT) to determine if BXCL501 (dexmedetomidine hydrochloride sublingual film) initiated in the ED in the hours after MVC to high risk individuals, treats/reduces ASR/ASD symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 100 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years and ≤ 65 years of age
✓. Admitted to ED 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
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
✕. Chronic daily opioid use prior to MVC (\> 20 mg oral daily morphine equivalents)
✕. Bipolar disorder, psychotic disorder, active psychosis, suicidal ideation, or homicidal ideation
✕. 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 10mm Hg within 3 minutes); (c) resting heart rate of \<55 beats per minute; (d) systolic blood pressure \<110mmHg or diastolic BP \<70mmHg; (e) participants with a 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 mEq/L)