Question Period Note: Psychedelics Therapy Study

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About

Reference number:
MHA-2023-QP-0019
Date received:
Dec 21, 2023
Organization:
Health Canada
Name of Minister:
Saks, Ya'ara (Hon.)
Title of Minister:
Minister of Mental Health and Addictions

Issue/Question:

There is significant interest in the potential use of psychedelics, particularly psilocybin (“magic mushrooms”) and MDMA, for the treatment of a variety of serious mental health conditions, including major depressive disorder, treatment-resistant depression, and post-traumatic stress disorder.
Sexual misconduct allegations related to MDMA clinical trials sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) have drawn media attention

Suggested Response:

We are deeply concerned about the mental health of Canadians, their families, and their communities.
While psychedelics like MDMA and psilocybin [sai·luh·sai·bn] have shown promise in clinical trials for the treatment of some illnesses, further research is needed.
Clinical trials are the most appropriate and effective way to advance research with unauthorized drugs, like psilocybin and MDMA, because they have safeguards in place to protect the health and safety of patients.
I'm very happy to report that the number of authorized clinical trials with these substances has increased significantly over the past year - a trend our government is hoping will continue.

Background:

N/A

Additional Information:

In Canada, psychedelic-assisted psychotherapy is being tested in clinical trials to treat patients with selected mental health disorders.
Health Canada’s role includes a rigorous, science-based review of clinical trial applications, as well as inspection activities to help ensure compliance with federal Good Clinical Practices requirements.
As of October 2023, Health Canada has authorized 31 clinical trials with psilocybin and 9 trials with MDMA and we are encouraging further research in this area.
Allegations of investigator misconduct in a clinical trial fall under the jurisdiction of the Research Ethics Board and/or the provincial College of Physicians and Surgeons, and not Health Canada.
The Department continues to monitor compliance and will not hesitate to take appropriate enforcement action, should non-compliance with federal requirements be identified.