Recruiting
Phase 2

BXCL501

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06943404

Conditions

Acute Stress Reaction

Acute Stress Disorder

Post-traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

BXCL501 (dexmedetomidine HCl)

Placebo

Study Details

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). 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.

Conditions

Acute Stress Reaction

Acute Stress Disorder

Post-traumatic Stress Disorder

Study ID

NCT06943404

Start date

Feb 23, 2026

Status verified date

Apr, 2026

Completion date

Sep 29, 2026

Anticipated

Primary completion date

Sep 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥ 18 years and ≤ 65 years of age
2. Admitted to ED within 72 hours of MVC
3. Anticipated to be discharged home from the ED
4. Stated willingness to comply with all study procedures and availability for the duration of the study
5. Consent to receive unencrypted communications
6. Has a smartphone with continuous service for ≥ 1 year
7. Has a personal email address they regularly access
8. Able to speak and read English
9. 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 Criteria:

1. Substantial comorbid injury (e.g., long bone fracture)
2. 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
3. Prisoner status
4. Chronic daily opioid use prior to MVC (> 20 mg oral daily morphine equivalents)
5. Bipolar disorder, psychotic disorder, active psychosis, suicidal ideation, or homicidal ideation
6. Hospital admission
7. 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%).
8. Hypomagnesia (<1.7 mg/dL) or hypokalemia (< 3.0 mEq/L)
9. Substantial hepatic impairment (e.g. AST or ALT > 3 times the upper limit of normal or history of cirrhosis).
10. 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)
11. Hypersensitivity or history of allergic reaction to dexmedetomidine
12. Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)
13. 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)
14. Participation in any other clinical trial of a pharmacological agent within 30 days prior to screening.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: BXCL501 (dexmedetomidine HCl)

Participants will be instructed to take an initial dose of BXCL501 (equivalent to 1 film, 120mcg) in the ED as part of enrollment procedures. If the time between the first dose and the planned bedtime of the participant is greater than 6 hours, participants will be instructed to take the second dose at bedtime on the day of enrollment. If the time between the first dose and the planned bedtime of the participant is less than 6 hours participants will be instructed to take the second dose before bedtime on the day following enrollment. Following the initial dosing on the day of enrollment, all participants will be instructed to take a dose of study medication before bedtime until they have completed 14 days of treatment.

placebo comparator: Placebo

Participants will be instructed to take an initial dose of placebo (equivalent to 1 film, 120mcg) in the ED as part of enrollment procedures. If the time between the first dose and the planned bedtime of the participant is greater than 6 hours, participants will be instructed to take the second dose at bedtime on the day of enrollment. If the time between the first dose and the planned bedtime of the participant is less than 6 hours participants will be instructed to take the second dose before bedtime on the day following enrollment. Following the initial dosing on the day of enrollment, all participants will be instructed to take a dose of study medication before bedtime until they have completed 14 days of treatment.

Interventions

BXCL501 (dexmedetomidine HCl)

BXCL501 (dexmedetomidine HCl) taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.

Placebo

Placebo taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.

Primary outcome measure

  • Change in ASD Score [ Time Frame: Week 1, 3 after MVC ]

Central Contacts and Locations

Central contacts

Locations

University of Florida College of Medicine - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Principal Investigator:

Sophia Sheikh, MD

UVA University Hospital

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

Glass George, MD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-04-14.