MDMA-Assisted Psychotherapy Phase II Trial Halted Amid Regulatory Concerns

Citing patient safety concerns, Health Canada, the nation’s department of government responsible for health policy, recently halted a Phase II clinical trial of MDMA-assisted psychotherapy being conducted in Toronto.

The trail was being sponsored by the mental health charity Remedy Institute.

Health Canada conducted an inspection on June 6 and issued a report with its findings on June 22. The Phase II trial was deemed non-compliant based on 12 observations. Among the trial’s shortcomings, the regulator reported that the trial sponsor failed to:

• Implement systems and procedures to ensure quality
• Provide medical care and/or make medical decisions under the supervision of a qualified investigator
• Receive written informed consent from every study participant before they joined the clinical trial

A full list of violations is available on the Health Canada website.

Remedy Institute founder Anne Wagner, who is also an adjunct professor of psychology at Toronto Metropolitan University, told the Canadian news organization CBC in an email that while the organization believed it had been compliant with federal regulations and that no study participants have been harmed, changes will be implemented.

"We welcome Health Canada's observations, and we are actively working to address them by hiring a leading regulatory compliance consultancy, revising documentation and administrative procedures, and creating better audit trail processes," Wagner wrote in her email to CBC.

The citation report issued to Remedy Institute followed an announcement by Health Canada in April that it would review all trials involving MDMA, following a complaint regarding a separate Phase II study being conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS). While findings from Health Canada’s investigation of the MAPS study are still being finalized, an initial summary notes deficiencies in “keeping good clinical practices” and “completeness, accuracy, or availability of the required records.”

References

Lindsay B. Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review. CBC. July 18, 2022. Accessed July 25, 2022.

Government of Canada. Health Canada. Clinical trial inspection report card summary: Good clinical practices (GCP) inspection. Health Canada; 2022. Accessed July 25, 2022.

Government of Canada. Health Canada. Initial inspection deficiencies. Health Canada; 2022. Accessed July 25, 2022.