BXCL501 After Stress to Increase Recovery Success

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). 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.

Conditions

• Acute Stress Reaction
• Acute Stress Disorder
• Post-traumatic Stress Disorder

Interventions

DRUG

BXCL501 (dexmedetomidine HCl)

BXCL501 (dexmedetomidine HCl) taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.

DRUG

Placebo

Placebo taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Mclean Hospital

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Rhode Island Hospital

  collaborator OTHER

• Vanderbilt University School of Medicine

  collaborator OTHER

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Samuel McLean, MD · University of North Carollina at Chapel Hill

• Stacey House, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-23

Primary Completion

2026-09-29

Completion

2026-09-29

FDA Drug

Yes

Countries

• United States

Study Locations