The Department of Veterans Affairs is launching research to determine whether psilocybin — the psychoactive ingredient in “magic mushrooms” — can be used safely and effectively to address veterans’ treatment-resistant depression and post-traumatic stress disorder.
The trial, known as the Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression,” or PIVOT, study aims to include at least 240 veterans, all of whom have difficult-to-treat major depressive disorder and some who also have PTSD.
The study will take place at five VA medical centers through June 2031 and will assess patients’ levels of depression before and after treatment, side effects and overall response among participants.
“Far too many veterans are living with mental health conditions that don’t respond to available treatments,” VA Secretary Doug Collinssaid in a statement. “Under President [Donald] Trump, VA is pursuing all avenues to evaluate new treatments and offer meaningful relief for those who have worn the uniform. This clinical trial reflects another step toward this goal.”
Last month, researchers with Ohio State University’s Center for Psychedelic Drug Research and Education published the findings of a small, 12-person study on the safety of using psilocybin to treat severe PTSD in veterans.
After receiving eight hours of psychotherapy and two doses of synthetic psilocybin and integrative therapy, nine participants, or 75%, no longer met the clinical criteria for having PTSD.
According to the research, published July 30 in Communications Medicine, participants showed no serious adverse effects, including suicidal ideation or behavior. Non-serious side effects included headache, anxiety and dizziness.
“For a population with severe treatment-resistant PTSD, these results are striking,” said Stacey Armstrong, associate director and senior researcher at the center.
The PIVOT study will involve veterans with major depressive disorder who have not responded to current treatments, including those with or without a diagnosis of PTSD. In the double-blind, randomized trial, veterans will receive one dose of psilocybin or a placebo, along with therapeutic support. They will receive a second dose one month later, also with support, and will be evaluated two to four weeks following each session.
They also will receive follow-up six months after their participation.
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