The U.S. Department of Veterans Affairs has started enrolling veterans in PIVOT, a Phase 3 trial of psilocybin for treatment-resistant depression. The VA's Office of Research and Development is the sponsor. Enrollment began August 3, 2026, with a target of about 240 veterans.1
How the trial works
- Who can join: veterans with major depression that hasn't improved with standard treatment, with or without PTSD.1
- Design: participants are randomly assigned to one of two psilocybin dose levels. There's no placebo arm, so the trial compares doses rather than psilocybin against nothing.1
- Where: VA sites in Birmingham and Tuscaloosa, Alabama; Portland, Oregon; Philadelphia; and Seattle.1
- When: main data collection is expected to finish in December 2030, with the full study ending in mid-2031.1
Veterans interested in taking part should ask their VA care team or check the trial's registry page for contact details.1
Part of a larger VA push
The VA says it's involved in about 20 active psychedelic-therapy trials.2 In July 2026, HHS and the VA signed a five-year agreement to expand veterans' access to trials, train VA clinicians to deliver any treatments the FDA approves, and share real-world data.3
Sources
- ClinicalTrials.gov, NCT07226232: Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression (PIVOT). clinicaltrials.gov
- The American Legion, "VA launches psilocybin trial for veterans with treatment-resistant depression," August 2026. legion.org
- U.S. Department of Health and Human Services, HHS and VA partnership on psychedelic therapies for veterans, July 2026. hhs.gov