Patient safety concerns discovered during an ongoing federal review have led to the suspension of one of two MDMA-assisted psychotherapy clinical trials currently underway in Canada.
According to Health Canada, the Phase II trial in Toronto, sponsored by a mental health charity called the Remedy Institute, received a non-compliance rating on June 22nd.
A spokesman told CBC in an email that the study was suspended “due to concerns for the safety of participants.”
The federal regulator summary of a June 6 inspection identifies 12 concerns with the project, including failure to conduct the study in accordance with the approved protocol, problems with quality control and staff training, and lack of informed written consent from participants.
The bulletin also says that medical care for the patients involved was done without the supervision of a qualified researcher.
Anne Wagner, founder of the Remedy Institute and adjunct professor of psychology at the Metropolitan University of Toronto, said her organization had believed they were complying with Health Canada regulations, but now they understand the changes are necessary.
“We welcome Health Canada’s comments and are actively working to address them by hiring a leading regulatory compliance consultancy, reviewing documentation and administrative procedures, and creating better follow-up processes. “audit,” Wagner wrote in an email.
He said no participant in the study has been harmed.
“All participants in our study have received safe doses of drugs approved by Health Canada and the Research Ethics Board, as well as ethical psychotherapy under the supervision of a licensed psychologist,” Wagner said.
Health Canada promised a review of all trials with MDMA in April, following a complaint from a group of academics, study participants and journalists about alleged sexual misconduct by two investigators in Vancouver, potential flaws in research conducted so far and reports of increased suicidal thinking in some patients.
Inspectors are still finalizing their findings on the second active MDMA study site in Montreal, where a Phase II trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) is underway.
Despite this, an initial summary of a June 6 inspection of the site says that “deficiencies were observed in conducting the clinical trial in accordance with good clinical practice … [and] in the integrity, accuracy or availability of the required records “.
The Health Canada spokesman said staff have also reviewed all previously authorized MDMA test applications and found nothing in the plans of these studies that suggest safety issues or breaches of regulatory requirements.
The complaint raised several concerns about the investigation
The review comes at a time when psychedelic drugs are becoming more commonplace and have been hailed in some corners as miracle drugs for serious psychiatric illnesses.
MDMA, a recreational drug also known as ecstasy or molly, produces feelings of euphoria and enhances sensation and suggestibility. Research so far has focused heavily on its potential, when combined with psychotherapy, to treat post-traumatic stress disorder.
Much of the information in the complaint that preceded the Health Canada review was obtained during the investigation of the team behind it. New York magazine podcast “Cover Story: Power Trip,” which explores the growing field of psychedelic therapy.
Co-presenter Lily Kay Ross filed the complaint with Health Canada after reviewing data from MAPS trials, talking to experts, and hearing participants about their experiences.
Three people who participated in Canadian MDMA-assisted psychotherapy trials told CBC they experienced an escalation in suicidal thoughts. (suriyachan / Shutterstock)
MAPS has described many of the complaints in the complaint as inaccurate and based in part on “lack of familiarity with the subject. “
The complaint alleges that MAPS incorrectly combined data from small study sites that used different methodologies to produce favorable results.
One of the most serious allegations is that some participants increasingly committed suicide during the trials, and not all of these experiences were included in the reported MAPS results.
CBC has spoken to three Canadian participants who said they experienced a sharp increase in suicidal thoughts during or immediately after the trials.
The complaint also questions whether enough was done to keep patients safe, pointing to videos from MAPS sub-investigators, Dr. Donna Dryer and Richard Yensen. stare, hug, spoon, and blindfold participant Meaghan Buisson during experimental sessions in Vancouver in 2015.
MAPS recorded the videos to make sure the therapists followed the accepted protocol and that the patients were safe, but the organization says staff did not see the videos until six years after they were filmed.
Yensen has admitted to having sex with Buisson after the end of the experimental sessions, but while she was still enrolled in the clinical trial. She has alleged it was sexual assaultbut Yensen argues that the relationship was consensual.
MAPS issued a statement in 2019 acknowledging that Yensen had an “inappropriate and unethical” sexual intercourse. with a study participant and said he was severing ties with the couple.