Phase 2A trial of the efficacy and safety of PT150 in the treatment of US veterans with posttraumatic stress disorder

The Defense Health Agency (DHA) awarded $2.48M to the Veterans Medical Research Foundation of San Diego under the Military Medical Research and Development program (CFDA 12.420) on September 30, 2025, to conduct a Phase 2A randomized controlled clinical trial evaluating the efficacy and safety of PT150 in treating posttraumatic stress disorder (PTSD) in U.S. military veterans. The four-year project, scheduled for completion on September 29, 2029, will be conducted at multiple Veterans Affairs (VA) medical centers, with research activities coordinated across sites to assess PT150's effectiveness in reducing PTSD symptoms, evaluate safety and tolerability, and explore secondary benefits in reducing alcohol use and enhancing fear extinction. The study will include structured recruitment protocols with emphasis on minority enrollment, informed consent procedures, data integrity management in coordination with a Data Safety Monitoring Board, and peer-reviewed publication of results.

Baylor College of Medicine serves as a sub-awardee under the project with specific operational responsibility for the Houston VA site. Dr. Verrico will serve as the Houston site principal investigator, supervising research staff, managing participant recruitment and enrollment, coordinating study harmonization with the lead investigator at San Diego VA, and ensuring compliance with institutional review board, VA Research and Development, and federal regulatory requirements. The sub-award was issued on February 19, 2026, and includes oversight of hypothesis development, experimental design, data acquisition, statistical analysis, and collaborative reporting of clinical trial outcomes.