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A Phase 2 Single-site, Double-blind, Placebo-controlled, Randomized Clinical Trial With an Open-label Extension Phase to Examine the Safety, Subjective Experiences, Acute Effects, and Suitability of Psilocybin Combined With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

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Trial Profile

A Phase 2 Single-site, Double-blind, Placebo-controlled, Randomized Clinical Trial With an Open-label Extension Phase to Examine the Safety, Subjective Experiences, Acute Effects, and Suitability of Psilocybin Combined With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Oct 2025

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At a glance

  • Drugs Psilocybin (Primary) ; Maltodextrin
  • Indications Alcoholism; Post-traumatic stress disorders
  • Focus Adverse reactions
  • Acronyms Psi-PS; Psi-PS

Most Recent Events

  • 28 Aug 2025 Planned primary completion date changed from 30 Mar 2026 to 1 Jun 2026.
  • 28 Aug 2025 Status changed from not yet recruiting to recruiting.
  • 07 Jul 2025 According to Filament Health Corp media release, the U.S. Food and Drug Administration (FDA) has authorized a phase 2 clinical trial of PEX010, for the treatment of alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in military veterans and first responders.

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