‘Corrective’ measures ordered, but Health Canada says 2nd MDMA trial can continue – CBC

Review conducted in response to complaint alleging patient safety issues and research flaws

Jul 22, 2022

Health Canada has completed its review of all active trials for MDMA-assisted psychotherapy, suspending one study because of patient safety concerns, but allowing the other to proceed with some “corrective and preventive” changes.

The federal regulator said Thursday that it has found the Multidisciplinary Association for Psychedelic Studies (MAPS) to be in compliance with Canadian regulations at its Phase II clinical trial in Montreal. That follows news that another study based in Toronto has been suspended.

However, MAPS has also been ordered to correct several problems inspectors identified during a visit to the study site, a Health Canada spokesperson told CBC in an email.

“While MAPS received a compliant rating, observations were noted during the inspection. This includes deficiencies related to: task delegation, ensuring accurate records, and timely training of the study team,” the email said.

Read more: https://www.cbc.ca/news/canada/british-columbia/health-canada-mdma-trial-compliant-1.6528137

NationTalk Partners & Sponsors Learn More