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Could a dissolving film under the tongue stop PTSD after a crash?

NCT ID NCT06943404

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a drug called BXCL501, given as a film under the tongue, can reduce acute stress and prevent post-traumatic stress disorder (PTSD) in people who have been in a motor vehicle collision. One hundred adults who come to the emergency department within 72 hours of a crash will receive either the drug or a placebo for two weeks. Researchers will track their stress symptoms, thinking abilities, and any side effects over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexmedetomidine (BXCL501) sublingual film
What this could lead to
If it works, this could offer a way to reduce stress symptoms and prevent long-term PTSD after a traumatic event like a car crash.
What could go wrong
This is an early phase 2 trial with only 100 people, so results may not apply to everyone. The drug may cause side effects like low blood pressure or drowsiness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UVA University Hospital

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Florida College of Medicine - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • Washington University in St. Louis

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

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