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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Psilocybin
DrugPsilocybin 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Active GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Target recruitment rate
A minimum recruitment rate of 70% of our target of 36 individuals within 6 months
Time frame
Within 6 months2
Retention rate
Retention rate of 90% at study completion
Time frame
Study Completion (8 months)3
Adherence to schedule
Adherence to scheduled study visits at a rate of 90% or higher at study completion.
Time frame
Through Study completion (8 months)Secondary outcomes
1
Scores on the GAD-7 Anxiety Scale
Scores on the GAD-7 Anxiety scale will be evaluated using a two-way mixed effects ANOVA with a between factor of GROUP and a within factor of TIME to determine the effect of the psilocybin and control interventions on symptoms of anxiety in firefighters. The scale reports scores with a lowest value of 0 representing "Not at all" experiencing the symptoms of what is asked in the questions. The highest score of 3 represents "Nearly every day" experiencing the symptoms of what is asked in the questions.
Time frame
Study Completion (8 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Empower Research Inc
Lead sponsor
Empower Psychedelics
Collaborator
Centre for Neurology Studies, Canada
Collaborator
Mitacs
Collaborator
Source ClinicalTrials.gov