VA launches PIVOT, a five-site randomized trial of psilocybin for veterans with treatment-resistant depression
The US Department of Veterans Affairs has announced a randomized controlled trial to test whether psilocybin can safely and effectively treat veterans with treatment-resistant major depressive disorder, including veterans who also have post-traumatic stress disorder. The study, called PIVOT, is the largest psilocybin trial the VA has undertaken.
What the trial will do
- Enrol at least 240 veterans diagnosed with treatment-resistant major depression, with or without co-occurring PTSD.
- Randomise participants between two psilocybin dose levels rather than against an inert placebo, a design that helps keep participants blinded.
- Run at five VA medical centres: the Birmingham VA Health Care System and Tuscaloosa VA Medical Center in Alabama, VA Portland Health Care System in Oregon, the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, and VA Puget Sound Health Care System in Seattle.
- Measure depression severity before and after treatment, side effects, and overall response, with the study running through June 2031.
Why it matters
Until now, VA-related psilocybin research has consisted of small pilot studies, most recently an Ohio State pilot in 12 veterans with severe PTSD. A multi-site randomised trial funded and run by the VA itself is the kind of evidence that could support psilocybin becoming an approved VA treatment, and it signals institutional acceptance of the therapy within the federal government's largest health system.
The trial follows the FDA's Breakthrough Therapy designation for psilocybin in treatment-resistant depression and a series of positive phase 2 results in civilian populations. Veterans have historically had limited access to psychedelic trials because most were run outside the VA system.