Actively Recruiting
Psychedelic-assisted Group Program for First Responders
Led by Empower Research Inc · Updated on 2024-06-24
32
Participants Needed
1
Research Sites
34 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
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
Official 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
- 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 anticipated changes during the study
- Medical clearance by the Investigator (MD) prior to enrollment
- Willing and able to attend two in-person sessions during the 12-week program, plus remote sessions
- Concurrent therapy allowed if stable for at least two months prior to screening and expected to remain stable
- Agree to consume usual caffeine amount or abstain on Week 10 morning
- Agree to refrain from nonprescription medications and certain supplements one week before drug sessions unless approved
- Agree to avoid alcohol within two days before 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 condition), 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
- Diagnosed psychotic disorder in first-degree relatives (except 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
- Uncontrolled cardiopulmonary disease, cardiovascular disease, or hypertension
- Any major illness interfering with study or posing health risk as judged by Investigator
- Psychoactive substance use (MDMA, psilocybin, LSD) within two months prior
- Pregnant, suspected, or planning pregnancy during study (females of child-bearing potential)
- Participation in another clinical trial currently or within last 30 days
- Current use of certain medications including rifamycins, anticonvulsants, nevirapine, efavirenz, taxol, dexamethasone, cytochrome P450 inhibitors, ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl, warfarin, metoprolol, propranolol, buspirone, tramadol, selegiline, sumatriptan
- Current use of inhibitors of UGT1A9 and 1A10, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, aldehyde dehydrogenase inhibitors (ALDHs), and alcohol dehydrogenase inhibitors (ADHs)
AI-Screening
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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
CONTACT
J
Jonathan Hill
CONTACT
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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