S.J.B.
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Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review
Bethany Lindsay
CBC
July 18th, 2022
Excerpt:
Bethany Lindsay
CBC
July 18th, 2022
Excerpt:
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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