Patient safety concerns uncovered during an ongoing federal review have led to the suspension of one of two MDMA-assisted psychotherapy clinical trials currently underway in Canada.
The Phase II trial in Toronto, sponsored by a mental health charity called the Remedy Institute, received a noncompliance rating on June 22, according to Health Canada.
A spokesperson told the CBC in an email that the study was halted “due to concerns for the safety of the participants.”
The federal regulator June 6 inspection summary identified 12 problems with the project, including failure to conduct the study according to the approved protocol, problems with quality control and staff training, and lack of informed written consent from participants.
The report card also says that the medical care of the participating patients occurred without the supervision of a qualified researcher.
Anne Wagner, founder of the Remedy Institute and assistant professor of psychology at Toronto Metropolitan University, said her organization had believed they were in compliance with Health Canada’s regulations, but now realize changes are needed.
“We welcome Health Canada’s observations and are actively working to address them by hiring a lead regulatory compliance consultant, revising documentation and administrative procedures and creating better audit follow-up processes,” Wagner wrote in an email.
She said none of the study participants were injured.
“All participants in our study received safe doses of medication approved by Health Canada and the Research Ethics Board, as well as ethical psychotherapy under the supervision of a licensed psychologist,” Wagner said.
Hello Canada promised a review of all trials involving MDMA in April, following a complaint by a group of academics, research participants and journalists about alleged sexual misconduct by two investigators in Vancouver, potential gaps in research conducted to date, and reports of increased suicidal ideation by some patients.
Inspectors are still finalizing their findings on the second active MDMA research site in Montreal, where a phase II trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) is underway.
However, initial inspection summary dated June 6 the site says that “deficiencies were noted in the conduct of the clinical trial in accordance with good clinical practice… [and] in the completeness, accuracy or availability of the required records.”
The Health Canada spokesperson said staff also reviewed all applications for pre-authorized trials of MDMA and found nothing in the plans for those trials to suggest safety issues or breaches of regulatory requirements.
The complaint raised several concerns about the research
The review comes at a time when psychedelic drugs are becoming more mainstream and are being hailed in some quarters as miracle cures for serious psychiatric conditions.
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 PTSD.
Much of the information in the complaint, which precedes Health Canada’s review, was obtained during research by the team behind it New York Magazine Podcast “Cover Story: Power Trip,” which explores the growing field of psychedelic therapy.
Co-host Lily Kay Ross filed the complaint with Health Canada after reviewing data from studies conducted by MAPS, talking to experts and hearing from participants about their experiences.
Three people who took part in Canadian trials of psychotherapy using MDMA told the CBC they had escalating suicidal thoughts. (suriyachan/Shutterstock)
MAPS characterized many of the criticisms in the complaint as inaccurate and based in part on “lack of knowledge of the subject.”
The complaint alleges that MAPS improperly mixed data from small study sites that used different methodologies to produce favorable results.
One of the most serious accusations is that some participants became increasingly suicidal during the trials, and these experiences were not included in the reported results of MAPS.
CBC spoke to three Canadian participants who said they experienced a spike in suicidal thoughts during or immediately after the ordeal.
The complaint also questions whether enough was done to protect patients, citing videos by MAPS sub-investigators Dr. Donna Dryer and Richard Jensen squeezing, cuddling, spooning and blindfolding participant Meaghan Buisson during experimental sessions in Vancouver in 2015.
MAPS recorded the videos to ensure therapists followed accepted protocol and patients were safe, but the organization says staff did not view the videos until six years after they were taken.
Jensen admitted that he had sex with Buisson after the experimental sessions ended, but while she was still enrolled in the clinical trial. She claims it was sexual assaultbut Jensen claims the relationship was consensual.
MAPS issued a statement in 2019 admitting that Jensen had “inappropriate and unethical” sexual relationship with a study participant and said she was ending ties with the couple.
Add Comment