A Phase 2 interventional study of BXCL501 (dexmedetomidine HCl) and Placebo in Acute Stress Reaction, Acute Stress Disorder and Post-traumatic Stress Disorder, sponsored by University of North Carolina, Chapel Hill. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Prevention
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Among 26 studies in Stress Disorders, Traumatic, Acute with a site in United States — 9 open to participants now, 9 under way, none of them phase 3. Stress Disorders, Traumatic, Acute · United States.
Among the 26 studies in Stress Disorders, Traumatic, Acute with a site in United States, this one is the 9th largest by planned enrollment of the 24 interventional ones that give a count, is one of 4 that started in 2026, is one of 6 in phase 2, and was the 19th registered.
58 studies on the registry are indexed under Stress Disorders, Traumatic, Acute; 15 are open to participants now.
Browse Stress Disorders, Traumatic, Acute studies →9 of the 26 studies in Stress Disorders, Traumatic, Acute with a site in United States are open now. Recruiting first, the newest first:
Walter Reed Army Institute of Research (WRAIR) · Sites in United States
Ages 18–40 · Healthy volunteers
Rhode Island Hospital · Sites in United States
Ages 12–17 · Healthy volunteers
University of Minnesota · Sites in United States
Ages 21–70 · Healthy volunteers
Walter Reed Army Institute of Research (WRAIR) · Sites in United States
Ages 18–40
University of North Carolina, Chapel Hill · Sites in United States
Ages 18–55
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Stress Disorders, Traumatic, Acute studies recruiting now, 2 set no upper age limit and 7 stop at 75 or younger; 1 takes children under 18; 3 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 1 · Phase 4 3
First in 2002; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is close to the median of 91 across 52 interventional studies indexed under Stress Disorders, Traumatic, Acute.
Median enrollment 73 across the 24 interventional studies, 172 across the 1 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 26 have an industry lead sponsor. The 10 most frequent:
University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
University of North Carolina, Chapel Hill has 3 studies filed under Stress Disorders, Traumatic, Acute — fewer than ten, so there is no comparison to draw.
5 of the studies in Stress Disorders, Traumatic, Acute with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06636786University of North Carolina, Chapel HillPrevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) | 2026-11 |
| NCT06482567University of North Carolina, Chapel HillPromoting Improved Functioning Among People Experiencing Stressful Situations | 2027-03 |
| NCT07197476Rhode Island HospitalAdolescent Stress and Substance Intervention Subsequent to Trauma | 2027-04 |
| NCT05427708University of Texas at AustinRespiratory Training in the Treatment of Transdiagnostic Pathological Anxiety | 2027-05 |
| NCT07654777Walter Reed Army Institute of Research (WRAIR)The Efficacy of Vitamin D Supplementation to Sustain Performance Outcomes | 2027-09 |
Add all 5 to your calendar (.ics) → With an account.
Among the 26 studies in Stress Disorders, Traumatic, Acute with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: BXCL501 (dexmedetomidine HCl)
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.
Drug: Placebo
BXCL501 (dexmedetomidine HCl) taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.
Also known as: BXCL501
Placebo taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.
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.
Time frame: Week 1, 3 after MVC
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.
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)
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.
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)
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.
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)
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.
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 1, 3, 6, 12 after MVC
Plan to share: 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).
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 12 months following publication and continuing for 36 months.
Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Sep 2026, 7 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Dexmedetomidine
Stress Disorders, Traumatic, Acute →
University of North Carolina, Chapel Hill →