Psychedelic-assisted Group Program for First Responders

NCT06471959 | Recruiting Phase 1 DMC

• 1 other identifier: EMP_Psilo_002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Psilocybin; Psychotherapy, Group

Outcome Measures

Primary Outcomes (3)

• Target recruitment rate

  A minimum recruitment rate of 70% of our target of 36 individuals within 6 months

  Within 6 months

• Retention rate

  Retention rate of 90% at study completion

  Study Completion (8 months)

• Adherence to schedule

  Adherence to scheduled study visits at a rate of 90% or higher at study completion.

  Through Study completion (8 months)

Secondary Outcomes (1)

• Scores on the GAD-7 Anxiety Scale

  Study Completion (8 months)

Study Arms (1)

Active Group

EXPERIMENTAL

All participants will undergo a 12-week, group-based program (one session per week, for 12 weeks). The first group session, as well as the Week 10 session will occur in-person. The remainder of the sessions will occur remotely. Each week, trained facilitators will help create a trauma-informed safe space for the group to thrive and promote cognitive resilience. The topics covered throughout the 12-week program include breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work. During Week 10, participants will be provided with either psilocybin (active group) or complete a breathwork day (control group). For participants randomized to the active group, they will receive 10mg of psilocybin on Week 10. A clinician certified and trained in the therapeutic use of psilocybin will be on site for participants in the psilocybin group.

Drug: Psilocybin

Interventions

Psilocybin DRUG

Psilocybin 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.

Also known as: PEX010

Active Group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Acute Stress Disorder
• Stable dose of medications for the last three months, with no changes anticipated for the duration of the study
• Medical clearance by the Investigator (MD) prior to study enrollment
• Willing and able to attend two in-person sessions throughout the 12-week program, in addition to remote sessions

You may not qualify if:

• 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
• Risk of suicide as determined by the Investigator
• Significantly intrusive PTSD as determined by the Investigator
• Uncontrolled cardiopulmonary disease, cardiovascular disease, or hypertension
• Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, vascular or any other major concurrent illness that, in the opinion of the Investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study
• Psychoactive substance use (MDMA, psilocybin, LSD) within the previous two months.
• If female and of child-bearing potential: pregnant, suspected or planning to become pregnant during the study
• Participation in another clinical trial (currently or within the last 30 days)
• Current use of rifamycins (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, taxol, dexamethasone); cytochrome P450 Inhibitors - including all HIV protease inhibitors, verapamil, diltiazem, itraconazole, ketoconazole, erythromycin, clarithromycin, azithromycin, and troleandomycin; 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).

Sponsors & Collaborators

• Empower Research Inc: lead
• Empower Psychedelics: collaborator
• Centre for Neurology Studies, Canada: collaborator
• Mitacs: collaborator

Study Sites (1)

Centre for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

RECRUITING

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Reginald Peters, MD

  University of British Columbia (Clinical Assistant Professor)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Campbell, MSc

CONTACT

1-778-874-7758; natashacampbell@healthtechconnex.com

Jonathan Hill

CONTACT

1-604-897-9115; jon@empresearch.co

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: All participants who pass screening and have been deemed eligible by the Investigator will be randomized during their baseline visit on a 1:1 ratio to either Group 1 (Control) or Group 2 (Intervention). Randomization will follow a randomization schedule which will be maintained by a person on the research team who is not directly involved with any assessments. This is an open-label study, and unblinding is not applicable (all participants will be aware of their group assignment).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One week prior to the dosing session, participants will be given a list of suggested guidelines designed to enhance the psilocybin experience. The suggestions are optional, but compliance will be recorded. Before arriving at the research unit on the morning of the dosing session day, they will be instructed to consume the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning and to eat a light breakfast. Participants in Group 2 (intervention) will be instructed to take ten (10) 1mg capsules at Week 10. Participants will be advised that the capsules should not be opened, chewed, or held in the mouth for an extended period without swallowing.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: June 24, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CA (1)