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, emphasised 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.”. 

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 

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