Last reviewed · How we verify
NCT06943404: RISE
BXCL501 After Stress to Increase Recovery Success
Phase 2 trial testing BXCL501 (dexmedetomidine HCl) in Acute Stress Reaction in 100 participants. Currently enrolling.
29 September 2026
Quick facts
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 100 |
| Start date | 23 February 2026 |
| Primary completion | 29 September 2026 |
| Estimated completion | 29 September 2026 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- BXCL501 (dexmedetomidine HCl) — full drug profile →
- Placebo
Conditions studied
- Acute Stress Reaction — all drugs for Acute Stress Reaction →
- Acute Stress Disorder — all drugs for Acute Stress Disorder →
- Post-traumatic Stress Disorder — all drugs for Post-traumatic Stress Disorder →
Sponsor
University of North Carolina, Chapel Hill
Who can join
Adults 18 to 65, any sex, with Acute Stress Reaction or Acute Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06943404
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Stress Reaction
Currently open trials in the same condition.
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Other University of North Carolina, Chapel Hill trials
Trials by the same sponsor.
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- NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
- NCT07534254 — Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06943404 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
- Last refreshed: 14 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06943404.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing