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BXCL501 After Stress to Increase Recovery Success

Study acronym: RISE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 14, 2026 (before its estimated September 29, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Recruitment opened Start date changed from estimate of Feb 11, 2026 to Feb 23, 2026 · Eligibility criteria expanded, about 21 words · Site details revised at 3 of 3 sitesv4 Show 3 more changesShow less
    • Start date changed from estimate of Feb 11, 2026 to Feb 23, 2026
    • Eligibility criteria expanded, about 21 words
    • Site details revised at 3 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Aug 29, 2025 to Feb 11, 2026 Study sites: 5 to 3 · Eligibility criteria expanded, about 17 wordsv3 Show 2 more changesShow less
    • Study sites: 5 to 3
    • Eligibility criteria expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Jun 5, 2025 to Aug 29, 2025 Study sites: 4 to 5v2 Show 1 more changeShow less
    • Study sites: 4 to 5
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06943404
Lead Sponsor University of North Carolina, Chapel Hill
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)
Conditions Acute Stress Reaction, Acute Stress Disorder, Post-traumatic Stress Disorder
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov