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Psychedelic-assisted Group Program for First Responders

NCT06471959 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-06-24

No results posted yet for this study

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

Conditions

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.

Sponsors & Collaborators

  • Empower Psychedelics

    collaborator UNKNOWN

  • Centre for Neurology Studies, Canada

    collaborator UNKNOWN

  • Mitacs

    collaborator INDUSTRY

  • Empower Research Inc

    lead INDUSTRY

Principal Investigators

  • Reginald Peters, MD · University of British Columbia (Clinical Assistant Professor)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-07-01
Completion
2025-09-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06471959 on ClinicalTrials.gov