FIRST RESPONDER CLINICAL TRIAL
PARTNERSHIP
MAPS Canada is excited to be in a research partnership with Empower Psychedelics, a non-profit organization based in British Columbia, on a groundbreaking study of psychedelic-assisted group therapy for first responders.
ABOUT OUR PARTNERSHIP
MAPS Canada is partnering with Empower Psychedelics toward a common commitment to support the utilization of psychedelic-assisted therapies through the conduct of a clinical trial to address mental and physical health challenges and promote wellness.
As part of this partnership, Empower Psychedelics will conduct a Health Canada approved clinical trial to assess the feasibility of a psilocybin-assisted group therapy program. This body of research will determine the efficacy of a group therapy program for first responders and veterans. The intention is to assess the most effective interventions and indications for a group therapy setting. MAPS Canada will support this project to raise funds that will go directly towards completing this clinical trial.
ABOUT THE CLINICAL RESEARCH
The purpose of this body of research is to assess the feasibility of a group therapy program, specifically for firefighters. (Advarra: Assessing the feasibility of a custom psychedelic-assisted group program on mental and physical health in firefighters Protocol PRo00066170).
Empower Psychedelics will submit a Clinical Trials Application to Health Canada, for approval of the group therapy protocol. Upon approval, the protocol will receive a No Objections Letter and Section 56 Exemption. The pilot of this program will include a group of 8 firefighters, and our intent is to expand this into a multi-site study across Canada, with 32-36 patients involved from across the country.
Our initial clinical sites are hosting groups in Surrey, BC, and Abbotsford, BC, with the intention of this fully approved clinical research study beginning to take place in Q4 2023. The pilot group of 8 firefighters will take part in an eight-week program, meeting once a week, each week, for 45 minutes in an online group setting. The group will then meet up on the final week in-person, where they will take a Health Canada approved psilocybin product (10-25mg) and undergo a series of activities including breath work, stretching, and psychological assessments from trained clinicians. Standard medical health questionnaires and scoring assessments will be utilized to gather evidence on the perceived and reported impacts from the patients – during the in-person integration session, and online one week after the session, and one month after the session.
Empower Psychedelics was recently awarded a Mitacs Accelerate grant (Mitacs Ref: IT32313) that will oversee the academic collaborations and assessments of this body of research over a two year period, beginning in September 2023. This grant is in collaboration with the University of Quebec in Montreal. We are considering additional academic collaborators from Alberta and Ontario institutions for new clinical sites, as well as grant funding opportunities. A small portion of the funding from this partnership will be utilized to continue to apply for additional grants in Canada and the US.
In order to support the research program, an ethics-approved research survey study was conducted from September 2021 to January 2022 (Advarra: Exploring Medically Perceived Benefits in Psychedelics and Cannabinoids: Observational Study with First Responders and Military Personnel Examining Previous Use Experience and Interest in participating in future Research studies: Protocol PRo00053720).
The purpose of this study was to gather information on the current conditions, interventions, and indications that were being experienced by individual first responders from around North America. Submissions were sent in from around the world, and 102 final survey responses were considered in the conclusions, which are currently in review for publication.
Based on the expressed interest from firefighter groups and individuals as a result of that study, our team has collaborated with the Centre of Neurology Studies to complete the group therapy protocol and clinical research with this specific audience. We intend to continue to expand this body of research across Canada and the US over the course of the next 2-3 years.
FIRST RESPONDER COMMUNITY
First responders are among the first to respond to disasters and emergency situations that may be challenging, dangerous, and emotionally taxing. This is part of the reason that it is estimated that 30 percent of first responders will develop behavioral health conditions including, but not limited to, depression, anxiety, and post-traumatic stress disorder (PTSD). This is well above the average for the general population and in studies of suicidality, firefighters were reported as the highest in the category for attempt and ideation rates.
While traditional treatment methodologies are often covered, at least minimally, under benefits packages as provided by provincial, federal and military health coverage plans, there is a growing need for not only a wider net of coverage, but to expand upon existing treatment methods. Firefighters, and first responders as a whole, are demonstrating an increased desire and openness to novel treatments, including psychedelic-based interventions, that are growing in popularity due to the exciting and positive early results of related studies and treatments.
ABOUT EMPOWER PSYCHEDELICS
Empower Psychedelics was founded in 2020, with a mission to provide safe and respectful access to psychedelics for professionals. The founding team has over a decade of experience in the cannabis sector, working with private and publicly traded companies in leadership roles.
The team also has several years of experience working as first responders, and has established significant interest from this community throughout North America.
Empower Psychedelics has advisors in Canada, USA, Australia, UK and Africa. If you would like to learn more about the organization, visit their website.
HOW YOU CAN HELP
If you would like to support this effort or get involved, please contact everyone@empresearch.co for further information. If you would like to learn more about the recruitment process, please mention your background and we will respond with additional details.
Your donations will help establish access to psychedelic-assisted therapies for first responders. This research will gather important information for Health Canada that will guide future developments, including new interventions and indications that could be appropriate for this group therapy setting.