Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review – CBC

Report on 2nd active clinical trial has yet to be finalized, but inspectors have identified ‘deficiences’

Jul 18, 2022

Patient safety concerns uncovered during an ongoing federal review have led to the suspension of one of two clinical trials for MDMA-assisted psychotherapy currently underway in Canada.

The Phase II trial in Toronto, sponsored by a mental health charity called the Remedy Institute, was issued a non-compliant rating on June 22, according to Health Canada.

A spokesperson told CBC in an email that the study was put on hold “due to concerns for participant safety.”

The federal regulator’s summary of a June 6 inspection identifies 12 concerns with the project, including a failure to conduct the study according to the approved protocol, problems with quality control and staff training, and a lack of informed written consent from participants.

The report card also says that medical care for the patients involved was happening without supervision from a qualified investigator.

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