The Department of Veterans Affairs (VA) has launched a new clinical trial to test the effectiveness and safety of psilocybin—the main ingredient in magic mushrooms—in treating veterans with treatment-resistant depression and post-traumatic stress disorder (PTSD).
The trial, called “Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression” (PIVOT), will be conducted at the following locations: Birmingham VA Health Care System and Tuscaloosa VA Medical Center in Alabama; VA Portland Health Care System in Oregon; Corporal Michael J. Crescenz VA Medical Center in Philadelphia; and VA Puget Sound Health Care System in Seattle, Washington.
The trial comes after President Donald Trump issued an executive order in April, calling on the U.S. Food and Drug Administration (FDA) to facilitate access to psychedelic drugs, including ibogaine compounds, psilocybin, ketamine, LSD and MDMA, for eligible patients suffering from major depressive disorder and substance abuse disorders.
The order directed federal agencies to fast-track psychedelic therapy research, allocating roughly $50 million through ARPA-H for state programs.
The VA hopes the trial will have a major impact on those living with mental health conditions like PTSD, which affects veterans with numerous physical and mental symptoms—including flashbacks to traumatic events—and is more common among veterans than civilians.
Roughly 7 out of every 100 veterans will have PTSD at some point in their life, according to the VA. In the general population, 6 out of every 100 adults (or 6%) will have PTSD in their lifetime.
“Far too many veterans are living with mental health conditions that don’t respond to available treatments,” said VA Secretary Doug Collins in a statement. “Under President 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.”
Other Psilocybin Trials
Researchers have long examined the efficacy of psilocybin in treating mental health conditions, though perhaps not as prevalent domestically as worldwide.
Psilocybin is authorized for treatment-resistant depression in Australia, while Switzerland also allows it in limited contexts.
As part of a recent clinical trial, researchers treated 12 former soldiers suffering with PTSD using psilocybin and found that after a month of treatment, nine of the 12 veterans in the trial no longer met the criteria for PTSD, according to a pilot study published July 30 in Communications Medicine. The study was conducted by researchers at the Center for Psychedelic Drug Research and Education at Ohio State University.
“For a population with severe treatment-resistant PTSD, these results are striking,” study co-author Stacey Armstrong, of Ohio State University, said in a statement about the trial.
In May, the VA announced a new clinical trial of methylenedioxymethamphetamine-assisted therapy (MDMA) to evaluate the safety and efficacy when treating current and former military personnel for severe mental health disorders, including PTSD. That trial will enroll some 80 veterans and will be conducted with the FDA.
Overall, the VA is involved in 20 active clinical trials in which they are testing psychedelic therapies for mental health conditions.
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