'Corrective' measures ordered, but Health Canada says 2nd MDMA trial can continue
Review conducted in response to complaint alleging patient safety issues and research flaws
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.
A summary of the inspection shows a list of nine problems with the trial, including several instances of failing to "implement systems and procedures to ensure the quality of the clinical trial."
The Health Canada spokesperson said MAPS must now "submit acceptable corrective and preventive actions to address all inspection observations."
CBC has reached out to MAPS for comment.
Review prompted by complaint
MDMA — a recreational drug also known as ecstasy or molly — produces feelings of euphoria and enhances sensation and suggestibility. Research to date has largely focused on its potential, when combined with psychotherapy, to treat post-traumatic stress disorder.
Health Canada promised a review of all trials involving MDMA in April, following a complaint from a group of academics, study participants and journalists about MAPS's research to date. It included alleged sexual misconduct by two investigators in Vancouver, potential flaws in the research and reports of increased suicidal thinking from some patients.
There are only two active trials underway in Canada.
The other one, sponsored by the Remedy Institute in Toronto in collaboration with MAPS, was previously found to be non-compliant with the Food and Drugs Act and suspended because of concerns about the safety of the participants.
The problems identified included 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 Remedy Institute, an Ontario-based charity, says it has hired a regulatory compliance consultancy to help it address the issues with its study.
Health Canada says staff have also reviewed all applications for previously authorized MDMA trials and found nothing in the plans for those studies that suggested safety problems or violations of regulatory requirements.