Phase II Trial with Psilocybin for End-of-Life Oncology Patients

Roots to Thrive

Clinical Trial

Roots to Thrive is a non-profit healthcare and research collective based in British Columbia that integrates evidence-based medicine with community and group-based healing.

The organization delivers innovative psychedelic-assisted therapy programs addressing trauma, depression, and end-of-life anxiety within regulated, ethically grounded frameworks. In partnership with clinical and academic collaborators, Roots to Thrive launched one of Canada’s first Phase II feasibility studies investigating group-based psilocybin-assisted psychotherapy for depression and anxiety in terminal cancer patients. 

Challenge

As an emerging leader in psychedelic-assisted therapy, Roots to Thrive required comprehensive support to prepare its first Health Canada–regulated clinical trial. 

The team needed to develop a full suite of compliant trial materials, establish regulatory and clinical infrastructure, and train staff across multiple disciplines in Good Clinical Practice (GCP). 

Unique challenges included: 

  • Developing inspection-ready documentation and processes for a novel psychedelic therapy trial 

  • Navigating Health Canada’s Clinical Trial Application (CTA) process and Section 56 exemptions for psilocybin use 

  • Coordinating Research Ethics Board (REB) submissions and site-level training for clinicians and facilitators with varying research experience 

Roots to Thrive sought a partner with deep expertise in regulatory strategy, trial design, and ethical oversight within the context of emerging psychedelic therapies. 

Solution

Changemark provided full regulatory, operational, and capacity-building support to help Roots to Thrive design, launch, and manage its first Health Canada–authorized clinical trial.  

The approach integrated rigorous compliance with adaptable, community-centered trial design, ensuring both scientific and ethical integrity across all components.  

The project included:

Regulatory Affairs + Trial Design 

  • Co-development of the clinical trial protocol and investigator brochure, aligning with ICH-GCP and Health Canada Division 5 requirements 

  • Preparation and management of all Health Canada submissions, including the Clinical Trial Application (CTA) and Section 56 exemptions for psilocybin 

  • Oversight of the full Research Ethics Board (REB) lifecycle, from submission to approval, continuing review, and close-out 

  • Creation of document control and version management systems to ensure inspection readiness and traceability  


Training + Capacity Building 

  • Delivery of customized Good Clinical Practice (GCP) and operations training for 8–19 physicians, therapists, and research staff 

  • Development of standard operating procedures (SOPs) to guide ongoing and future psychedelic research 

  • Integration of quality management systems and compliance monitoring tools to sustain long-term research capacity

Results

The trial achieved REB approval, Health Canada authorization, and successful pre-inspection clearance, marking a major milestone for psychedelic-assisted therapy research in Canada. 

Impact Highlights:

  • All documentation and processes met Division 5 standards for inspection readiness 

  • Research and clinical staff fully trained in GCP principles and trial conduct 

  • Established a replicable clinical and regulatory framework for future psychedelic research initiatives 

  • Positioned Roots to Thrive as a national leader in advancing safe, ethical, and community-grounded psychedelic therapy 

By embedding regulatory precision, clinical rigor, and experiential learning, Changemark helped establish the foundation for sustainable, evidence-based psychedelic research within a clinical care context. 

Interested in Learning More?

Let’s talk about how we can help you design and operationalize compliant clinical trials in emerging areas of care. 

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