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Scottsdale Research Institute (SRI) is an Arizona-based research organization conducting the world's first controlled clinical trial of whole psilocybin mushrooms. Their FDA-approved Phase 1 study tests naturally-grown whole mushrooms (30mg psilocybin dose) for PTSD in first responders and military veterans, funded by $5M from the Arizona Legislature. The study explores the entourage effect hypothesis compared to isolated synthetic psilocybin. Led by Dr. Sue Sisley.

Development Programmes

1

Whole Psilocybin Mushroom (Psilocybe cubensis)

Psilocybin
Phase I

PTSD in first responders and veterans — 4.32g whole mushroom in chocolate capsule (~30mg psilocybin). First-ever FDA-authorized whole mushroom psilocybin trial.

Programme Tracker

PTSD

Primary: US (FDA)
Phase IActive

Phase 1/2 enrolling (NCT07275970). 24 participants: 8 police, 8 firefighters, 8 military veterans. 4.32g whole Psilocybe cubensis mushroom in chocolate form (~30mg psilocybin). Group therapy setting. First patient enrolled late 2025. Dr. Sue Sisley leads study. Arizona state funded (~$2.7M of $5M appropriation). Partnered with Alira Health for regulatory support.

Milestones

Phase I started

Completed

Actual: Dec 1, 2025

First patient enrolled — Army veteran Nick Jones became the first participant in the whole mushroom trial

Why it matters: First dosing confirms the trial is operational. The group therapy format with whole mushroom in chocolate form is unique among clinical psychedelic trials. 24-participant design across police, firefighter, and veteran populations will test generalizability across first-responder groups.

Watch next: Enrollment of all 24 participants and initial safety data

Regulatory review accepted

Completed

Actual: Jan 1, 2025

FDA authorized Phase 1/2 trial using whole psilocybin mushroom — first-ever FDA authorization for a whole mushroom product in a clinical trial

Why it matters: FDA authorization for a whole botanical mushroom product (not synthetic or extracted psilocybin) is a regulatory landmark. All prior FDA-authorized psilocybin trials used synthetic (COMPASS/GH Research) or extracted (Filament) forms. The "entourage effect" hypothesis — that other mushroom compounds enhance or modulate the therapeutic response — can now be tested clinically. Dr. Sue Sisley holds the only DEA Schedule I license for farming psilocybin mushrooms for human research.

Watch next: Enrollment completion and Phase 1/2 safety/efficacy data

Funding milestone

Completed

Actual: May 1, 2023

Arizona legislature approved $5M for psilocybin research; SRI ultimately awarded ~$2.7M

Why it matters: State government funding for a psilocybin trial is unprecedented in the US. Arizona's bipartisan support signals growing political acceptance of psychedelic research. The $2.7M funds the first-ever FDA-authorized whole mushroom clinical trial.

Recorded Events

Dec 1, 2025: Phase I started

Jan 1, 2025: Regulatory review accepted

May 1, 2023: Funding milestone

Quick Facts

Type
Non-Profit
Lead Stage
Phase I
Website
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