On July 7, 2025, Filament Health Corp. announced that the U.S. Food and Drug Administration has granted authorization to initiate a Phase 2 clinical trial of its botanical psilocybin candidate, PEX010, aimed at treating alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in military veterans and first responders. Led by Dr Nathan Sackett at the University of Washington School of Medicine’s Centre for Novel Therapeutics in Addiction Psychiatry, this study represents the first investigation into the safety of psilocybin when combined with structured psychological support in individuals experiencing both conditions concurrently.
Addressing an Unmet Need in Mental-Health Care
Military veterans and first responders are disproportionately affected by co-occurring AUD and PTSD, yet current treatment options seldom address both disorders simultaneously. Despite extensive evidence supporting psychedelic-assisted therapies for each condition independently, no prior trial has evaluated their combined application. As Dr Sackett observes, people experiencing both AUD and PTSD have very limited evidence-based treatment options, particularly among those who have served or protected their communities.
Study Design and Therapeutic Approach
Enrolment is open to participants diagnosed with both AUD and PTSD. Each subject will receive a single oral dose of 25 mg PEX010, followed by a series of non-directive psychological support sessions. This supportive model emphasises careful safety monitoring, empathetic presence during the psychedelic experience, and subsequent integration sessions to help individuals process insights and promote lasting therapeutic benefit.
Insight from the Experts
Dr Sackett emphasises the novelty of the dual-diagnosis focus, noting that this will be the first study to investigate psilocybin-assisted support in a population experiencing both AUD and PTSD. Benjamin Lightburn, Co-Founder and CEO of Filament Health, adds that veterans and first responders dedicate their lives to protecting others yet are often left behind with regard to mental-health treatments. He expresses pride in contributing to urgently needed research that could shape the future of care for those who have given so much to their communities.
Funding, Timeline and Enrolment
The State of Washington is providing financial support for this trial, underscoring growing governmental interest in psychedelic-assisted therapies. Recruitment is underway and participants can find enrolment information at the official study link. Initial safety data are expected by fall 2026, which will guide the design of larger efficacy studies in this high-risk group.
Future Directions
Should the Phase 2 trial establish a favourable safety profile, Filament Health intends to advance PEX010 into Phase 3 trials, potentially expanding its dual-diagnosis approach to other populations. The company’s botanical platform aims to deliver standardised, naturally derived psychedelic medicines with consistent dosing and quality controls, meeting rigorous regulatory standards and ensuring patient safety moving forward.
About Filament Health
Headquartered in Vancouver, BC, Filament Health Corp. (OTC: FLHLF) is a clinical-stage developer of natural psychedelic therapeutics. The company focuses on proprietary extraction and formulation methods to create botanical psilocybin drug candidates for neuropsychiatric and substance-use disorders. Filament’s mission is to bring safe, standardised psychedelic medicines to patients as rapidly as possible, paving the way for novel treatments in mental health care.
