Actively Recruiting
Assessing the Feasibility of a Custom Psychedelic-assisted Group Program on Mental and Physical Health in First Responders
Led by Empower Research Inc ยท Updated on 2024-06-24
32
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
E
Empower Research Inc
Lead Sponsor
E
Empower Psychedelics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a customized psychedelic-assisted group program designed for firefighters and first responders to promote cognitive resilience and mental health. This feasibility study compares a 12-week group program combined with either a 10mg dose of oral psilocybin or a breathwork day at Week 10. The program includes weekly sessions focused on breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work, delivered in a trauma-informed safe space. All participants attend a 12-week group program with one weekly session. The first session and Week 10 session happen in person, while other sessions are remote. At Week 10, participants either receive a 10mg oral psilocybin dose under clinical supervision or complete a breathwork day if assigned to the control group. Psilocybin is given in capsules containing a partially purified mushroom extract called PYEX, with trained clinicians present during dosing. Participants will be assessed at baseline, mid-program (Week 6), end of program (Week 12), and at 6 months follow-up. Researchers monitor recruitment, retention, and adherence rates. Mental health outcomes such as anxiety levels are measured using the GAD-7 Anxiety Scale. Safety and overall study participation last about 8 months, with participants attending both in-person and remote sessions and receiving clinical support during dosing days.
CONDITIONS
Brief Title
Psychedelic-assisted Group Program for First Responders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Clinically diagnosed with a mental health condition such as depression, chronic anxiety, obsessive-compulsive disorder, PTSD, unresolved grief, adjustment disorder, or acute stress disorder
- Stable dose of medications for the last three months, with no changes anticipated during the study
- Medical clearance by the Investigator (MD) prior to enrollment
- Willing and able to attend two in-person sessions and remote sessions during the 12-week program
- Concurrent therapy allowed if stable in type and frequency for at least two months prior and expected to remain stable
- Agree to consume usual caffeine amount before Week 10 visit or abstain if not usual consumer
- Agree to refrain from certain nonprescription supplements and medications one week before drug sessions unless approved
- Agree to avoid alcohol within two days prior to Week 10 visit
- Agree not to take "as needed" medications on the morning of Week 10 visit
- Agree to use highly effective contraception methods during the study (females)
- Normal body mass index (BMI 18.5-24.9)
You will not qualify if you...
- Current or past history of schizophrenia, psychotic disorders (unless substance induced or medical), bipolar disorder, delusional disorder, dissociative disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anorexia nervosa, bulimia nervosa or substance abuse
- Presence of active psychotic symptoms
- Psychotic disorder diagnosis in first-degree relatives (except those secondary to medical reasons)
- Diagnosis of dementia or delirium
- Risk of suicide as determined by Investigator
- Significantly intrusive PTSD as determined by Investigator
- Extreme emotional lability disruptive to group environment
- Uncontrolled cardiopulmonary disease, cardiovascular disease, or hypertension
- Any major concurrent illness that may interfere with study results or pose health risks
- Psychoactive substance use (MDMA, psilocybin, LSD) within previous two months
- Pregnant, suspected pregnancy, or planning pregnancy during the study (females of child-bearing potential)
- Participation in another clinical trial currently or within last 30 days
- Current use of specific medications including rifamycins, anticonvulsants, HIV protease inhibitors, cytochrome P450 inhibitors, ergot alkaloids, certain antidepressants, and others as listed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take part in a 12-week, group-based program with weekly sessions focused on breath-work, mindfulness, and other therapeutic techniques. The first session and the Week 10 session are held in-person, while other sessions are conducted remotely. During Week 10, participants in the active group receive a 10mg dose of psilocybin under clinical supervision.
1 in-person session at start, 1 in-person dosing session at Week 10, and 10 remote sessions
Trial Site Locations
Total: 1 location
1
Centre for Neurology Studies
Surrey, British Columbia, Canada, V3V 0C6
Actively Recruiting
Research Team
N
Natasha Campbell, MSc
J
Jonathan Hill
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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