BXCL501 for Acute Stress Disorder
(BASIS Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires you to stop taking certain medications, including those for alcoholism, some sedative antidepressants, and specific blood pressure medications. However, non-sedative antidepressants for PTSD are allowed.
What data supports the effectiveness of the drug BXCL501 for treating acute stress disorder?
The research suggests that drugs blocking norepinephric hyperactivity, like prazosin, show promise in treating stress-related conditions such as PTSD. This indicates that similar mechanisms might be effective for acute stress disorder, potentially supporting the use of BXCL501 if it has similar properties.12345
Is BXCL501 safe for humans?
What is the purpose of this trial?
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.
Research Team
Samuel McLean, MD
Principal Investigator
University of North Carollina at Chapel Hill
Stacey House, MD
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for individuals who have experienced a Motor Vehicle Collision and are at high risk of developing acute stress reactions or post-traumatic stress. Participants will receive treatment in the Emergency Department and must be able to take medication sublingually (under the tongue).Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BXCL501 or placebo in the ED and continue treatment for 14 days with a sublingual film
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of psychological and somatic symptoms, neurocognitive function, and adverse events
Treatment Details
Interventions
- BXCL501
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
University of Florida
Collaborator
Vanderbilt University School of Medicine
Collaborator
Washington University School of Medicine
Collaborator
Mclean Hospital
Collaborator
United States Department of Defense
Collaborator
Rhode Island Hospital
Collaborator
Walter Reed Army Institute of Research (WRAIR)
Collaborator