Acute Stress ReactionPhase 2RISENCT06943404
BXCL501 After Stress to Increase Recovery Success
A Phase 2 study testing BXCL501 (dexmedetomidine HCl) in people with Acute Stress Reaction and Acute Stress Disorder, run by University of North Carolina, Chapel Hill at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Stress Reaction, Acute Stress Disorder, Post-traumatic Stress Disorder
- What is being tested?
- BXCL501 (dexmedetomidine HCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Feb 2026to 29 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UVA University Hospital
Charlottesville, Virginia, 22908
Glass George, MD
- Recruiting
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, 32209
Sophia Sheikh, MD
- Not yet recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Stacey House, MD
About this study
Official title: Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With a Sublingual Formulation of Dexmedetomidine (BXCL501)
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.
Read the detailed description
U.S. military personnel are exposed to life-threatening traumatic events (e.g., intense firefights with multiple casualties) that result in acute stress reaction (ASR) symptoms (ICD-10) and posttraumatic stress (PTS). Similarly, acute and persistent stress symptoms, and related adverse posttraumatic neuropsychiatric sequelae, are also very common and cause a tremendous burden of suffering in civilian populations following exposure to life-threatening traumatic events (e.g., motor vehicle collision, violent or accidental death of a loved one, and assault). BXCL501 (dexmedetomidine HCl sublingual film) has been evaluated in multiple clinical trials across a range of medical conditions (dementia, schizophrenia, bipolar disorder, opioid use disorder), with an excellent safety profile, and evidence of efficacy with respect to decreasing agitation. This is promising for the treatment of ASRs, as agitation is a primary feature of ASRs in many individuals. Additionally, adrenergic hyperactivity is also a key characteristic of ASRs and contributes to the development of Posttraumatic Stress Disorder (PTSD). BXCL501 is known to decrease the activity of central noradrenergic neurons, suggesting a mechanistic pathway by which BXCL501 may improve outcomes for individuals at risk of ASR/ASD/PTSD. BXCL501 therefore holds significant promise as a treatment aimed at reducing ASR symptoms and related behavioral changes, enhancing resilience and improving warfighter performance, and reducing the frequency and severity of persistent/chronic PTS symptoms. This study will evaluate the safety and efficacy of BXCL501 in a population of trauma survivors at high risk for developing ASR, ASD, and PTSD symptoms, and may ultimately provide military personnel, veterans, and civilians with an important new treatment option to improve recovery, job performance, and quality of life when administered in the early aftermath of exposure to a traumatic stressor.
- Being tested
- BXCL501 (dexmedetomidine HCl), Placebo
- Medical subject headings
- Stress Disorders, Traumatic, Acute, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXCL501 (dexmedetomidine HCl)Drug
Also called BXCL501
BXCL501 (dexmedetomidine HCl) taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.
PlaceboDrug
Placebo taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BXCL501 (dexmedetomidine HCl) | Experimental | 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. Receives: Drug: BXCL501 (dexmedetomidine HCl) |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ASD Score
Individuals are asked to complete the 14-item Acute Stress Disorder Scale (ASDS) self-report inventory where each item is rated on a 5-point scale (0= Not at all; 1= Mildly; 2= Medium; 3= Quite a bit; 4= Very Much) that indexes acute stress disorder (ASD). Range of possible total scores is 0-56, with higher total scores indicating greater acute stress symptoms.
Measured: Week 1, 3 after MVC
Secondary outcomes (8)
Median reaction time of correct responses (general cognitive function)
General cognitive function will be assessed using the Test My Brain Digit Symbol Matching Test. Participants will be asked to match symbols and numbers using a symbol-number key shown on screen. General cognitive function is assessed via measuring median reaction time of correct responses (medianRTc) to 'test' trials. Range for medianRTc (ms) is 0-30000.
Measured: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Median reaction time of correct responses (procedural reaction time)
Procedural reaction time will be assessed using the Test My Brain Choice Reaction Time Test. Participants see a set of three arrows, where one arrow is a different color from the rest. The participant presses left or right to indicate the direction of the odd colored arrow. Reaction time is assessed via measuring median reaction time of correct responses (medianRTc) to 'test' trials. Range for medianRTc (ms) is 0-5000.
Measured: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Proportion of targets correctly identified (visuospatial processing and attention)
Visuospatial processing and attention will be assessed using the Test My Brain Multiple Object Tracking Test. In this test of visuospatial processing and attention, participants have to track a set of target circles around the screen (amidst a field of distractors) that move at increasing speed with each trial. Once the circles stop moving, participants select which were targets must identify targets instead of distractors. Visuospatial processing and attention are assessed via the proportion of targets correctly identified. Range for measure is 0-1.
Measured: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
d-prime identification (psychomotor vigilance)
Psychomotor vigilance will be assessed via the Test My Brain Gradual Onset Continuous Performance Test. In this task, participants monitor a stream of city and mountain images that rapidly fade from one to the next with no interstimulus interval. Participants are asked to press/touch for each city image and to withhold for each mountain image. Vigilance is assessed via measuring d-prime for identification of each city image, a signal detection-based measure that takes into account both hits and false alarms to provide an unbiased estimate of performance where higher values reflect better performance. Response inhibition is defined as the suppression of actions that are inappropriate in a given context. Response inhibition is assessed using results from the above, by measuring the number of commission errors (failure to withhold responses) where most positive scores reflect more impulsive responding. Range for measure is -4.2279 to 4.2279.
Measured: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Change in Pain Symptom Score
The Regional Pain Scale (RPS) will be used to assess the extent of body pain. 13 items will be scored on a 0-10 pain scale where 0 is no pain and 10 is severe pain. Range of possible total scores is 0-130, with higher total scores indicative of greater pain symptoms
Measured: Baseline, Week 1, 3, 6, 12 after MVC
Change in Depressive Symptoms Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8b; an 8-item scale, and one question from the PROMIS Depression Item Bank will be aggregated/combined to assess depression. Each item is scored on a 5-point scale where 0 is "none of the time" and 5 means "all or almost all of the time". Range of possible total scores is 0-45, with higher total scores indicative of greater depressive symptoms.
Measured: Baseline, Week 1, 3, 6, 12 after MVC
Change in Somatic Symptom Score
The Pennebaker Inventory of Limbic Languidness (PILL) assesses the frequency of common physical symptoms and sensations. The investigators will use a version with adapted response options for greater consistency across measures, greater precision in response levels, and to allow administration via self-report. 20 items will be scored on a 0-10 scale where 0 is "no problem" and 10 means "major problem". Range of possible total scores is 0-200, with higher total scores indicative of greater somatic symptoms.
Measured: Baseline, Week 1, 3, 6, 12 after MVC
Change in PTSD Symptoms
The PTSD Checklist for DSM-5 (PCL-5) assesses PTSD symptoms as defined by the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5). 20 items will be scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Range of possible total scores is 0-80, with higher total scores indicative of greater PTSD symptoms.
Measured: Baseline, Week 1, 3, 6, 12 after MVC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start23 Feb 2026
- Primary completion29 Sep 2026 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress ReactionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Mclean Hospital, Washington University School of Medicine, University of Florida, Rhode Island Hospital, Vanderbilt University School of Medicine, Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Samuel McLean, MD, Principal investigator, University of North Carollina at Chapel HillStacey House, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943404
- Sponsor's protocol ID
- 25-0345
- Acronym
- RISE
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina at Chapel Hill (UNC).
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With a Sublingual Formulation of Dexmedetomidine (BXCL501)
- ClinicalTrials.gov ID
- NCT06943404
- Acronym / sponsor ID
- RISE / 25-0345
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- United States Department of Defense, Mclean Hospital, Washington University School of Medicine, University of Florida, Rhode Island Hospital, Vanderbilt University School of Medicine, Walter Reed Army Institute of Research (WRAIR)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
U.S. military personnel are exposed to life-threatening traumatic events (e.g., intense firefights with multiple casualties) that result in acute stress reaction (ASR) symptoms (ICD-10) and posttraumatic stress (PTS). Similarly, acute and persistent stress symptoms, and related adverse posttraumatic neuropsychiatric sequelae, are also very common and cause a tremendous burden of suffering in civilian populations following exposure to life-threatening traumatic events (e.g., motor vehicle collision, violent or accidental death of a loved one, and assault). BXCL501 (dexmedetomidine HCl sublingual film) has been evaluated in multiple clinical trials across a range of medical conditions (dementia, schizophrenia, bipolar disorder, opioid use disorder), with an excellent safety profile, and evidence of efficacy with respect to decreasing agitation. This is promising for the treatment of ASRs, as agitation is a primary feature of ASRs in many individuals. Additionally, adrenergic hyperactivity is also a key characteristic of ASRs and contributes to the development of Posttraumatic Stress Disorder (PTSD). BXCL501 is known to decrease the activity of central noradrenergic neurons, suggesting a mechanistic pathway by which BXCL501 may improve outcomes for individuals at risk of ASR/ASD/PTSD. BXCL501 therefore holds significant promise as a treatment aimed at reducing ASR symptoms and related behavioral changes, enhancing resilience and improving warfighter performance, and reducing the frequency and severity of persistent/chronic PTS symptoms. This study will evaluate the safety and efficacy of BXCL501 in a population of trauma survivors at high risk for developing ASR, ASD, and PTSD symptoms, and may ultimately provide military personnel, veterans, and civilians with an important new treatment option to improve recovery, job performance, and quality of life when administered in the early aftermath of exposure to a traumatic stressor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BXCL501 (dexmedetomidine HCl) | Experimental | Drug: 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 | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BXCL501 (dexmedetomidine HCl)Also: BXCL501BXCL501 (dexmedetomidine HCl) taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks. | Drug | BXCL501 (dexmedetomidine HCl) |
| PlaceboPlacebo taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks. | Drug | Placebo |
Primary outcome
Change in ASD Score
Time frame: Week 1, 3 after MVC
Individuals are asked to complete the 14-item Acute Stress Disorder Scale (ASDS) self-report inventory where each item is rated on a 5-point scale (0= Not at all; 1= Mildly; 2= Medium; 3= Quite a bit; 4= Very Much) that indexes acute stress disorder (ASD). Range of possible total scores is 0-56, with higher total scores indicating greater acute stress symptoms.
8 secondary outcomes
Median reaction time of correct responses (general cognitive function)
Time frame: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Median reaction time of correct responses (procedural reaction time)
Time frame: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Proportion of targets correctly identified (visuospatial processing and attention)
Time frame: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
d-prime identification (psychomotor vigilance)
Time frame: Min 30, Hour 1, 6, 12, Day 1, 2, 3, Week 1, 2, 3, 5, 6, 8, 11, 12 after MVC
Change in Pain Symptom Score
Time frame: Baseline, Week 1, 3, 6, 12 after MVC
Change in Depressive Symptoms Score
Time frame: Baseline, Week 1, 3, 6, 12 after MVC
Change in Somatic Symptom Score
Time frame: Baseline, Week 1, 3, 6, 12 after MVC
Change in PTSD Symptoms
Time frame: Baseline, Week 1, 3, 6, 12 after MVC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina at Chapel Hill (UNC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel McLean, MD principal investigator
University of North Carollina at Chapel Hill
Stacey House, MD principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BXCL501 (dexmedetomidine HCl) in people with Acute Stress Reaction and Acute Stress Disorder, run by University of North Carolina, Chapel Hill at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romina Soudavari, MPH (9843195030, romina_soudavari@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ASD Score (time frame: Week 1, 3 after MVC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.