RecruitingPhase 2NCT06943404

BXCL501 After Stress to Increase Recovery Success

Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With a Sublingual Formulation of Dexmedetomidine (BXCL501)

Sponsor

University of North Carolina, Chapel Hill

Enrollment

100 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Stress Disorder Acute Stress Reaction

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

≥ 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
Females of childbearing potential (not surgically sterilized (tubal ligation/hysterectomy) or not post-menopausal (no menstrual period for > 12 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 Criteria14

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
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)
Substantial hepatic impairment (e.g. AST or 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) adrenergic agents prescribed for other reasons (prazosin); e) or medications known to cause QT prolongation. (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)
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)
Participation in any other clinical trial of a pharmacological agent within 30 days prior to screening.