Could a dissolving film under the tongue stop PTSD after a crash?
NCT ID NCT06943404
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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UVA University Hospital
RECRUITINGCharlottesville, Virginia, 22908, United States
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University of Florida College of Medicine - Jacksonville
RECRUITINGJacksonville, Florida, 32209, United States
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Washington University in St. Louis
NOT_YET_RECRUITINGSt Louis, Missouri, 63110, United States
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