MDMA-assisted psychotherapy trial halted due to patient safety issues

Jul 26, 2022

Two clinical trials for MDMA-assisted psychotherapy have been halted due to patient safety concerns that arose during an ongoing federal review, as written about by Bethany Lindsay for CBC. On June 22, Health Canada announced that the Phase II trial currently underway in Toronto and sponsored by a mental health charity called the Remedy Institute, was issued a non-compliant rating.

Specifically, the summary released following inspection includes 12 concerns related to the project, including 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. “Deficiencies were noted in conducting the clinical trial in keeping with good clinical practices … [and] in the completeness, accuracy or availability of the required records,” states the report.

Furthermore, the summary also states that medical care for the patients involved was happening without supervision from a qualified investigator.

According to Dr. Anne Wagner, founder of the Remedy Institute and an adjunct professor of psychology at Toronto Metropolitan University, her organization had believed they were compliant with Health Canada regulations, but realized they need to implement changes.

“We welcome Health Canada’s observations, and we are actively working to address them by hiring a leading regulatory compliance consultancy, revising documentation and administrative procedures, and creating better audit trail processes,” Wagner said in an email to CBC News.

Dr. Wagner added that no study participants have been harmed. “All participants in our study have received the safe dosages of medication approved by Health Canada and the Research Ethics Board, as well as ethical psychotherapy under the supervision of a licensed psychologist,” she said.

Health Canada announced that it will be conducting a review of all trials involving MDMA in April 2023, following a complaint from a group of academics, study participants, and journalists regarding alleged sexual misconduct by two investigators in Vancouver, as well as potential flaws in the research and reports of increased suicidal thinking from some patients.

Currently, inspectors are still finalizing their findings about the second active MDMA study site in Montreal, where a Phase II trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) is being carried out.

The complaint to Health Canada was submitted by Lily Kay Ross, the co-host of New York magazine’s podcast “Cover Story: Power Trip,” which explores psychedelic therapy. Ross reviewed the data from trials conducted by MAPS, and interviewed experts and participants about their experiences.

However, MAPS described the criticisms listed in the complaint as inaccurate and based in part on “a lack of familiarity with the subject matter.”

Moreover, the complaint submitted to Health Canada alleges that MAPS had improperly blended data from small study sites that used different methodologies to produce favourable results.

In addition, it alleged that certain participants became increasingly suicidal during the trials, and those experiences weren’t all included in MAPS’ reported results.

The complaint also raises the question of whether enough was done to keep patients safe, highlighting videos of MAPS sub-investigators Dr. Donna Dryer and Dr. Richard Yensen pinning down, cuddling, spooning, and blindfolding participant Meaghan Buisson during experimental sessions in Vancouver in 2015.

While MAPS had recorded the videos to ensure therapists were following the accepted protocol and patients were safe, the organization says staff didn’t watch the videos until six years after they were filmed.

Dr. Yensen had admitted to having sex with Buisson after the experimental sessions ended, but while she was still enrolled in the clinical trial. However, Buisson has alleged it was sexual assault, but Yensen argues the relationship was consensual. In 2019, MAPS issued a statement acknowledging that Dr. Yensen had an “inappropriate and unethical” sexual relationship with a study participant while Dr. Dryer knew about it and failed to disclose it, after ceasing collaboration with the couple.