The world’s largest medical psilocybin access and data project set to launch, led by Canadian non-profit TheraPsil. Real-world data aims to inform development of regulated psilocybin therapy
TheraPsil, in collaboration with Drug Science have announced the launch of the world’s largest medical psilocybin access and data-collection project, ‘Project Solace’.
The objectives of Project Solace are two-fold. The primary objective is to expand legal access to psilocybin medicine for Canadian patients suffering from conditions such as end-of-life distress, Major Depressive Disorder and other serious conditions for which traditional treatment options have failed. The secondary objective of Project Solace is to develop a substantial body of evidence, using a real-world data registry, to document clinical effectiveness, safety, and clinician and patient reported outcomes in patients who have received psilocybin-assisted psychotherapy by access to psilocybin through Canada’s Special Access Program (the “SAP”) or under exemptions authorizing possession of psilocybin
The SAP is Health Canada’s preferred pathway, outside of clinical trials, for patients in medical need to access legal psilocybin-assisted psychotherapy and psilocybin for medical purposes. Unfortunately, the SAP is inaccessible to many patients for at least three reasons. The SAP is limited to emergency situations where other treatments have been tried and failed. Accessing the SAP requires working through layers of bureaucracy and puts unfettered discretion in the hands of the government. Finally, healthcare professionals who are proficient in psilocybin assisted psychotherapy, and carry the confidence to request this treatment option are few and far between.
Professor of Neuropsychopharmacology at Imperial College London and Founder and Chair of Drug Science, David Nutt, emphasized that:
“The Canadian Special Access Program has the potential to provide thousands of Canadian patients with a life-changing opportunity to receive psilocybin-assisted psychotherapy from a team of trained medical professionals. The clinical trial procedure is not an appropriate process for many patients due to the severity of the conditions that psilocybin-assisted psychotherapy attends to treat. Project Solace will be the largest database of prescribed psilocybin in the world and real-world data gathering helps us to understand how these drugs are affecting patients.”
Through Project Solace, TheraPsil will support prescribing healthcare practitioners in Canada to feel confident and capable to request psilocybin-based medical products on behalf of their patients through the SAP. As part of ensuring patient safety and treatment efficacy, TheraPsil will also identify and connect prescribing healthcare professionals with trained treatment therapy teams across Canada that will support patients in medical need through the facilitation of psilocybin-assisted psychotherapy. Project Solace plans to begin assisting patients in 5 primary regions in British Columbia, Ontario and Quebec, and plans to expand as additional treatment teams are onboarded.
TheraPsil’s Director of Research, Julia Joyes, Msc highlighted that:
“The SAP represents a giant leap forward in our healthcare system, allowing unprecedented early access to medications that are clearly on the path to full Health Canada approval. This expanded access also presents an invaluable opportunity to collect real-world data on the use of psychedelic medicine in clinical practice. We should certainly cherish this opportunity.
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TheraPsil will help patients connect to prescribing healthcare professionals who can request cGMP psilocybin from licensed dealers enrolled in Project Solace. Enrolled suppliers of psychedelic compounds so far include HAVN Life Sciences, Filament Health and Psygen.
A patient who has been able to access a psilocybin-based medical product named Thomas Hartle, had this to say:
“Getting access to this proven treatment through the SAP is bittersweet for me. I am grateful to receive the treatment. However, the vast majority of Canadians who need this therapy do not have access to the level of professional support that TheraPsil provided to me, and that played such a great role in my SAP application being approved.”.
Patients who consent to participate in Project Solace will complete standard healthcare questions at various points in their psilocybin-therapy journey.
Dr. Houman Farzin MD, MSc a family medicine and palliative care physician who has prescribed a psilocybin-based medical product through the SAP, added that:
“The SAP represents a giant leap forward in our healthcare system, allowing unprecedented early access to medications that are clearly on the path to full Health Canada approval. This expanded access also presents an invaluable opportunity to collect real-world data on the use of psychedelic medicine in clinical practice. We should certainly cherish this opportunity.”.
The anonymised data collected through Project Solace will be provided to regulatory bodies including Health Canada, to facilitate decision-making surrounding the regulatory system for the future of medicalized psilocybin.
The data will also be released to licensed dealers enrolled in Project Solace and the general public.
Psilocybin manufacturers interested in enrolling in Project Solace are encouraged to email the Project Solace Director – James Bunn at james@therapsil.ca.
For more information about project solace, and how to get involved as either a patient or healthcare professional, visit the Project Solace webpage here.
TheraPsil is a Canadian non-profit dedicated to advocating for patients in medical need of psilocybin and psilocybin-assisted psychotherapy.
Learn more at therapsil.ca.
Media contact
John Gilchrist – john@therapsil.ca
All other inquiries
Spencer Hawkswell, CEO, TheraPsil – spencer@therapsil.ca