FDA Approves Psilocybin Trial for Veterans and First Responders With PTSD and Alcohol Use Disorder

A new clinical trial using a botanical psilocybin drug to treat co-occurring PTSD and alcohol use disorder (AUD) in veterans and first responders has received approval from the U.S. Food and Drug Administration. The study, which is being led by Dr. Nathan Sackett at the University of Washington’s Center for Novel Therapeutics in Addiction Psychiatry, will evaluate the safety of Filament Health’s psilocybin drug candidate, PEX010. Participants will receive a single 25 mg dose of psilocybin alongside non-directive psychological support, including safety monitoring, empathetic presence, and integration therapy.

According to Dr. Sackett, this marks the first time a clinical trial will assess psilocybin-assisted therapy for individuals suffering from both PTSD and AUD—conditions that frequently overlap but often lack effective dual treatments, especially among military and emergency personnel.

“Despite significant overlap between AUD and PTSD, there is a lack of evidence-based treatment options for people experiencing both conditions, particularly among veterans and first responders, who are disproportionately affected,” said Dr. Sackett in a statement.

The trial is being funded by the State of Washington and is now enrolling participants. Results are expected by fall 2026.

Benjamin Lightburn, CEO and co-founder of Filament Health, said the company is honored to support research focused on improving mental health outcomes for those who have served their communities.

“Veterans and first responders dedicate their lives to protecting others, yet are often left behind with regard to mental health treatments,” said Lightburn. “We’re proud to contribute to this urgently needed research.”

Filament Health, a clinical-stage drug development company based in Canada, specializes in natural psychedelic medicines and is developing the first FDA-approved drug candidates derived from natural psilocybin.