Canada: MDMA-Assisted Therapy Trials Reviewed By Health Canada, Here's What's Happening

Health Canada has just completed a review of all active MDMA-assisted psychotherapy trials, in response to alleged patient safety issues and research flaws.

The issues had resulted in one of the two existing studies being suspended while the other allowed to proceed with some "corrective and preventive" changes.

On July 21, the federal regulator stated MAPS’ phase 2 trial in Montreal has proven to be in compliance with Canadian regulations. On the other hand, the Toronto phase 2 study led by the Remedy Institute had been suspended over patient safety concerns on June 22. 

As CBC news earlier reported, an inspection identified 12 concerns with the project, including failure to address the approved protocol, issues with quality control and staff training, absence of informed written consent from participants and even medical care for the patients happening without supervision from a qualified researcher.

The review came as a state response to a complaint made in April by a group of academics, study participants and journalists on alleged sexual misconduct by two investigators in Vancouver, potential research flaws and reports of increased suicidal thinking on behalf of some patients.

While the MAPS study qualified to continue, it has also been ordered to correct several problems, including those related to task delegation, accurate recording and timely study training. MAPS must now "submit acceptable corrective and preventive actions to address all inspection observations."

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