A Community of Practice Program With Psilocybin-assisted Therapy for End-of-Life Patients

This Phase I interventional study (n=64) focuses on assessing the feasibility of a resilience-focused community of practice program that incorporates psilocybin-assisted therapy for patients experiencing end-of-life distress. Conducted at the Snuneymuxw Traditional Medicines Clinic in Nanaimo, B.C., the program runs over 10 weeks and includes one group-administered psilocybin-assisted therapy session. Data, coordinated through RedCap and hosted by Island Health, will be collected to understand the feasibility, safety, and mental health impacts of this community of practice.

The trial aims to treat patients with a terminal diagnosis and end-of-life distress, eligible for the Roots to Thrive (RTT) + Psilocybin-assisted Therapy Treatment program. Data collection involves attendance tracking, biomedical measures during psilocybin sessions, quantitative health and wellness questionnaires, and qualitative surveys and exit interviews.

The study started on September 1, 2023, with an estimated primary completion date of April 30, 2025, and overall completion by October 31, 2025. The inclusion criteria for participants include having a terminal diagnosis, aged 19-80 years, ambulatory, and experiencing emotional distress unresponsive to other treatments. Exclusion criteria involve factors such as ongoing illicit drug use, unstable housing conditions, and certain psychiatric conditions.

The study design is an early-phase I interventional trial with a single-group assignment and an open-label approach. The primary purpose is treatment, and the study involves administering psilocybin-assisted therapy within a community-of-practice model. The primary outcome measures include safety monitoring, biomedical measures, and feasibility outcomes, while secondary outcomes involve attendance during the study intervention and post-treatment qualitative surveys.

The study is sponsored by The Roots to Thrive Society for Psychedelic Therapy and collaborates with Vancouver Island Health Authority and Vancouver Island University.

Trial Details

The purpose of the study is to understand the feasibility of a resilience focused community of practice program that includes psilocybin-assisted therapy for End-of-Life Distress. The community of practice refers to a research informed group therapy process that runs over a 10-week period of time and includes one group administered psilocybin-assisted therapy session. Target population: The treatment team will treat a total of 64 patients who have: • a terminal diagnosis (experiencing end of life distress), • AND who are eligible for the RTT + Psilocybin-assisted Therapy Treatment program through the RTT Society.

NCT Number NCT05958758

Data attribution

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