Health Canada allows second MDMA trial to continue

Sep 9, 2022

After a review of active MDMA-assisted psychotherapy trials, Health Canada has suspended one study due to patient safety concerns, while allowing others to continue with “corrective and preventive” changes. Bethany Lindsay reported the follow-up with CBC, here.

According to a statement released by Health Canada in July, it determined that the Multidisciplinary Association for Psychedelic Studies (MAPS) is compliant with Canadian regulations at its Phase II clinical trial in Montreal. In contrast, the study based in Toronto was suspended.

In addition, MAPS has been required to correct several problems identified during an inspection visit to the study site, according to an email correspondence between a Health Canada spokesperson and CBC News. “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.

According to the released summary of the inspection, there were nine problems identified regarding the trial, including failing to “implement systems and procedures to ensure the quality of the clinical trial.” Moreover, the Health Canada spokesperson said that MAPS is required to “submit acceptable corrective and preventive actions to address all inspection observations.”

Earlier in April, Health Canada received a complaint from a group of researchers, study participants, and journalists regarding MAPS’ research, including alleged sexual misconduct by two study investigators in Vancouver, as well as potential research flaws and patients reporting an increased incidence of suicidal thoughts.

The currently suspended MDMA trial carried out in Toronto is sponsored by the Remedy Institute in collaboration with MAPS, and was found to be non-compliant with the Food and Drugs Act and became suspended due to concerns regarding the safety of study participants.

Specifically, the problems identified included a failure to conduct the study according to the approved protocol, issues regarding quality control and staff training, and a lack of informed written consent from participants.

A statement released by Health Canada mentions that all applications for previously authorized MDMA trials have been reviewed, with no findings suggesting safety problems or violations of regulatory requirements.