Psychedelic-assisted Group Program for First Responders
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19-65
SponsorEmpower Research Inc
About this trial
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
Eligibility criteria
Qualifiers
Male or female, 19 to 65 years of age
Must be a first responder, any work status (Employed full-time or part-time, Off-work, Retired, Volunteer)
Fluent in English
Able to understand the informed consent form, study procedures and willing to participate in study
Disqualifiers
Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, dissociative disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anorexia nervosa, bulimia nervosa or substance abuse, as assessed by medical history
Presence of active psychotic symptoms
Currently diagnosed psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain, as assessed by medical history.
Diagnosis of dementia or delirium
Trial design
Treatments tested in this trial
- Psilocybin
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Empower Research Inc
Lead sponsor
Empower Psychedelics
Collaborator
Centre for Neurology Studies, Canada
Collaborator
Mitacs
Collaborator
Source ClinicalTrials.gov