Longitudinal experiences of Canadians receiving compassionate access to psilocybin-assisted psychotherapy
In a prospective longitudinal survey of eight Canadian cancer patients granted compassionate Section 56 access, psilocybin-assisted psychotherapy produced significant two-week improvements in anxiety, depression, pain, quality of life and spiritual well‑being, consistent with clinical‑trial results. The small sample size and at least one substantial negative outcome highlight the need for formal real‑world evaluation and surveillance as legal access expands.
Authors
- Robin Carhart-Harris
- David Erritzoe
- Hannes Kettner
Published
Abstract
Recent clinical trials have found that the serotonergic psychedelic psilocybin effectively alleviates anxiodepressive symptoms in patients with life-threatening illnesses when given in a supportive environment. These outcomes prompted Canada to establish legal pathways for therapeutic access to psilocybin, coupled with psychological support. Despite over one-hundred Canadians receiving compassionate access since 2020, there has been little examination of these ‘real-world’ patients. We conducted a prospective longitudinal survey which focused on Canadians who were granted Section 56 exemptions for legal psilocybin-assisted psychotherapy. Surveys assessing various symptom dimensions were conducted at baseline, two weeks following the session (endpoint), and optionally one day post-session. Participant characteristics were examined using descriptive statistics, and paired sample t-tests were used to quantify changes from baseline to the two-week post-treatment endpoint. Eight participants with Section 56 exemptions (four females, Mage = 52.3 years), all with cancer diagnoses, fully completed baseline and endpoint surveys. Significant improvements in anxiety and depression symptoms, pain, fear of COVID-19, quality of life, and spiritual well-being were observed. Attitudes towards death, medical assistance in dying, and desire for hastened death remained unchanged. While most participants found the psilocybin sessions highly meaningful, if challenging, one reported a substantial decrease in well-being due to the experience. These preliminary data are amongst the first to suggest that psilocybin-assisted psychotherapy can produce psychiatric benefits in real-world patients akin to those observed in clinical trials. Limited enrollment and individual reports of negative experiences indicate the need for formal real-world evaluation programs to surveil the ongoing expansion of legal access to psychedelics.
Research Summary of 'Longitudinal experiences of Canadians receiving compassionate access to psilocybin-assisted psychotherapy'
Introduction
Recent clinical trials indicate that one or two high doses of psilocybin, when delivered with psychological support, can produce rapid and clinically meaningful reductions in depression and anxiety among people with life-threatening illness. De La Salle and colleagues note that these trial findings have driven regulatory changes internationally and prompted interest in providing psilocybin-assisted psychotherapy (PAP) outside of research settings. However, compassionate access pathways operate in heterogeneous, less-controlled conditions than clinical trials: formulations (mushrooms versus synthetic psilocybin), dosing, therapist training, preparation/integration procedures, and patient selection can all differ, and the effects of such real-world differences on safety and effectiveness are unknown. This study aimed to fill that gap by prospectively surveying Canadians who received legal, compassionate access to psilocybin via Section 56 exemptions. The investigators sought preliminary longitudinal data on patient characteristics, acute session features, changes in mood, anxiety, quality of life, spiritual well-being and attitudes toward death and medical assistance in dying (MAiD), and to document adverse effects and subjective experiences following a single PAP session in naturalistic settings.
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Study Details
- Study Typeindividual
- Journal
- Compound
- Topics
- Authors
- APA Citation
de la Salle, S., Kettner, H., Thibault Lévesque, J., Garel, N., Dames, S., Patchett-Marble, R., Rej, S., Gloeckler, S., Erritzoe, D., Carhart-Harris, R., & Greenway, K. T. (2024). Longitudinal experiences of Canadians receiving compassionate access to psilocybin-assisted psychotherapy. Scientific Reports, 14(1). https://doi.org/10.1038/s41598-024-66817-0
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Cited By (1)
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Jungwirth, J., Westenhöfer, S., Aicher, H. et al. · Preprints (2025)
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