The U.S. Department of Veterans Affairs (VA) is launching a new clinical trial to investigate whether psilocybin can help military veterans who are struggling with treatment-resistant depression.
The move follows VA’s recent announcement of a separate trial on MDMA-assisted therapy in treating veterans with severe mental health disorders, including PTSD and alcohol use disorder.
The new psilocybin and depression research announced on Wednesday, titled “Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression,” or PIVOT, will also include veterans concurrent PTSD.
The randomized, controlled trial—which comes on the heels of an executive order President Donald Trump signed in April with the aim of expediting psychedelic therapy access—will be conducted at five separate VA medical centers across Alabama, Oregon, Pennsylvania and Washington State.
“Far too many veterans are living with mental health conditions that don’t respond to available treatments,” VA Secretary Doug Collins said in a press release. “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.”
The psilocybin study will compare outcomes between two different dosage levels and will assess levels of depression before and after the psychedelic treatment, as well as tolerability of side effects.
The research “reflects VA’s commitment to pursuing innovative solutions for veterans who have not responded to existing treatments,” the department said in a press release.
Collins, the VA secretary, recently touted psychedelic therapy development at an event in Florida, saying that “we’re making massive progress in how we diagnose things, but also how we do new treatments, which in the past was more of a wait-and-see approach, and now we’re being more cutting-edge.”
Last month, VA and the Department of Health and Human Services (HHS) launchd a new partnership to collaborate on research and development of psychedelic medicines to treat people struggling with serious mental health conditions.
HHS Secretary Robert F. Kennedy Jr. said recently that the Trump administration is “very anxious” to create a pathway for access to psychedelics therapy and that top officials across federal agencies want to “get it out to the public as quickly as possible.”
In an interview on the Joe Rogan Experience in February, Kennedy said he’s confident “we’re going to get it done,” with plans to develop and finalize rules that would enable patients with conditions such as post-traumatic stress disorder (PTSD) and depression to access psychedelic substances like psilocybin and MDMA in a “very controlled setting.”
“Everybody in my agency…is very anxious to get a rule out there that will allow these kind of studies and will allow access under therapeutic settings, particularly [for] the military soldiers who have suffered these injuries to get access to these products,” the HHS secretary said. “We’re working through that process now. We’re all working on it and trying to make it happen.”
“I think that we’re going to get it done,” he said.
Last June, Kennedy said his agency is “absolutely committed” to expanding research on the benefits of psychedelic therapy and, alongside of the head of FDA, is aiming to provide legal access to such substances for military veterans “within 12 months.”
Collins disclosed last year that he had an “eye-opening” talk with Kennedy about the therapeutic potential of psychedelic medicine. And he said he’s open to the idea of having the government provide vouchers to cover the costs of psychedelic therapy for veterans who receive services outside of VA as Congress considers pathways for access.
Photo courtesy of Mark Groeneveld.
