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RECRUITING
NCT06471959
PHASE1/PHASE2

Psychedelic-assisted Group Program for First Responders

Sponsor: Empower Research Inc

View on ClinicalTrials.gov

Summary

This study is a two-group feasibility study of oral psilocybin combined with a 12-week group-based program, customized for firefighters. Trained facilitators will help create a trauma-informed space for the group (n = 6-8) to thrive and promote cognitive resilience. The topics covered throughout the 12 weeks include breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work. Group 1 (control): 12-week group-based program, with a breathwork day at week 10 Group 2 (intervention): 12-week group-based program, with a 10mg dose of psilocybin (PEX010) at Week 10 Assessment timepoints: * Baseline * Mid-program (Week 6) * End of program (Week 12) * 6-month follow up

Official title: Assessing the Feasibility of a Custom Psychedelic-assisted Group Program on Mental and Physical Health in First Responders

Key Details

Gender

All

Age Range

19 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-01-01

Completion Date

2025-09-01

Last Updated

2024-06-24

Healthy Volunteers

No

Interventions

DRUG

Psilocybin

Psilocybin in the study comes in the form of the study drug, PYEX. PYEX is a drug substance which is a partially purified fraction of the extract of Psilocybe cubensis mushroom fruiting bodies. It is a mixture of indole alkaloids, other mushroom fruiting body components and stabilization excipients. The major indole alkaloids present include psilocybin and psilocin (dephosphorylated psilocybin). PEX010 is a capsule for oral administration and is manufactured with PYEX (12.5-14.0% psilocybin), excipients, and HPMC (hydroxypropyl methyl cellulose) capsules.

Locations (1)

Centre for Neurology Studies

Surrey, British Columbia, Canada