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News Release

VA Portland Health Care System Named One Of Five VA Sites To Test Efficacy Of Psilocybin As Treatment For Depression - 08/07/26

VA Portland HCS today announced its participation in a new clinical trial to evaluate the effectiveness and safety of psilocybin to treat major depression in Veterans, including those with concurrent posttraumatic stress disorder (PTSD).

 

The new trial comes after President Trump’s recent executive order on “Accelerating Medical Treatments for Serious Mental Illness.” Among other things, the order aims to increase clinical trial participation and accelerate innovative research models and drug approvals for psychedelic drugs.

 

“VA Portland is committed to exploring every evidence-based avenue to improve the mental health and well‑being of the Veterans we serve,” said Karla Azcuy Director of The VA Portland HCS “By participating in this trial, our facility is helping advance innovative research into new treatment options that may offer meaningful relief for Veterans, both here in the Portland/Vancouver area and across the country.”

 

VA’s trial, titled "Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression," or PIVOT, reflects VA's commitment to pursuing innovative, evidence-based solutions for Veterans who have not responded to existing treatments.

 

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 dosages of psilocybin. The study will measure effectiveness by comparing participants’ levels of depression before treatment and after treatment. It will also assess PTSD symptom severity, tolerability of side effects, and overall patient-reported depression.

 

The health and safety of Veterans who choose to participate in this trial is VA’s top priority. Investigational treatments will be delivered 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.

 

Psychedelic drugs are a class of substances that alter consciousness or awareness and can be organically or synthetically produced. 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).

 

For more information, contact Megan Crowley at megan.crowley@va.gov or 503915807.

VA Portland Health Care System Named One Of Five VA Sites To Test Efficacy Of Psilocybin As Treatment For Depression - 08/07/26

VA Portland HCS today announced its participation in a new clinical trial to evaluate the effectiveness and safety of psilocybin to treat major depression in Veterans, including those with concurrent posttraumatic stress disorder (PTSD).

 

The new trial comes after President Trump’s recent executive order on “Accelerating Medical Treatments for Serious Mental Illness.” Among other things, the order aims to increase clinical trial participation and accelerate innovative research models and drug approvals for psychedelic drugs.

 

“VA Portland is committed to exploring every evidence-based avenue to improve the mental health and well‑being of the Veterans we serve,” said Karla Azcuy Director of The VA Portland HCS “By participating in this trial, our facility is helping advance innovative research into new treatment options that may offer meaningful relief for Veterans, both here in the Portland/Vancouver area and across the country.”

 

VA’s trial, titled "Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression," or PIVOT, reflects VA's commitment to pursuing innovative, evidence-based solutions for Veterans who have not responded to existing treatments.

 

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 dosages of psilocybin. The study will measure effectiveness by comparing participants’ levels of depression before treatment and after treatment. It will also assess PTSD symptom severity, tolerability of side effects, and overall patient-reported depression.

 

The health and safety of Veterans who choose to participate in this trial is VA’s top priority. Investigational treatments will be delivered 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.

 

Psychedelic drugs are a class of substances that alter consciousness or awareness and can be organically or synthetically produced. 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).

 

For more information, contact Megan Crowley at megan.crowley@va.gov or 503915807.