WASHINGTON — The U.S. Department of Veterans Affairs today announced the launch of a new clinical trial to evaluate the effectiveness and safety of psilocybin to treat major depression in Veterans, including those with concurrent post-traumatic stress disorder.
The new trial comes after President Trump’s recent executive order on “Accelerating Medical Treatments for Serious Mental Illness,” which aims to increase clinical trial participation and accelerate innovative research models and drug approvals for psychedelic drugs.
VA’s trial, titled “Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression,” or PIVOT, reflects VA’s commitment to pursuing innovative solutions for Veterans who have not responded to existing treatments.
“Far too many Veterans are living with mental health conditions that don’t respond to available treatments,”said VA Secretary Doug Collins. “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 randomized, controlled trial will enroll Veterans diagnosed with treatment-resistant major depressive disorder, with or without concurrent PTSD, and will compare outcomes between two psilocybin dosage levels. The study will also assess participants’ levels of depression before and after treatment, tolerability of side effects, and overall patient-reported depression.
The trial will be conducted in five 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 health and safety of Veterans who choose to participate in this trial is VA’s top priority. The trial will be conducted in a safe, controlled, clinical setting using pharmaceutical-grade drugs under careful quality controls, stringent safety protocols that were developed with FDA, and in a setting that includes psychological support.
In addition to this trial, VA is involved in 20 active clinical trials focused on psychedelic therapies for mental health conditions. All VA research — including research into psychedelics – is conducted under strict safety protocols and in full compliance with federal guidelines.
The U.S. Food and Drug Administration has granted breakthrough therapy designation to several companies developing psychedelic substances, including MDMA, psilocybin and LSD, allowing for expedited review of these drugs. Clinical use of these therapies outside of research will only be considered by VA once FDA approval is granted.
VA strongly discourages self-medicating or attempting to replace other mental health treatment options with psychedelics or any other unprescribed substances. Proven, evidence-based treatments, are currently available at VA facilities to treat Veterans with mental health conditions. Veterans should always consult their health care providers before making any treatment decisions.
The trial is registered with ClinicalTrials.gov (NCT07226232).
