drugset / Trial / NCT06471959
Psychedelic-assisted Group Program for First Responders
Phase 1/2
Unknown
32 enrolled
Empower Research Inc
Centre for Neurology Studies, Canada · collabEmpower Psychedelics · collabMitacs · collab
NaSequentialOpen-labelTreatment
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
Timeline
- Start
- 2025-01-01
- Primary completion
- 2025-07-01
- Completion
- 2025-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psilocybin | Other / unclassified | 10 mg | Oral |
Indications
No indication recorded.