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MDMA trials under review in Canada due to alleged abuse by study participants | Canada

All clinical trials of the psychoactive drug MDMA are under review by Canadian regulators after complaints of abuse of study participants by a pioneering American psychedelic research organization.

The California-based Multidisciplinary Association for Psychedelic Studies (Maps) has led the way by conducting trials on the medicinal qualities of the drug. In May 2021, he published the results of a phase three trial in the journal Nature on the benefits of the drug – commonly sold illegally in powder form or in ecstasy tablets – as a breakthrough treatment for PTSD, for which there is currently no effective pharmaceutical product. treatment.

But government regulator Health Canada confirmed it had announced a review of Maps-sponsored MDMA clinical trials that were partly conducted in Canada, following a complaint detailing “alleged investigator misconduct “.

The suit was filed by the producers of the New York magazine Cover Story: Power Trip podcast, who heard testimony from several former trial participants complaining about their MDMA and psychotherapy treatment sessions.

In an incident in 2015Video obtained and shared by Meaghan Buisson, a patient with PTSD, shows two therapists guiding her through an MDMA session in Vancouver while picking her up and restraining her in an alleged attempt to help her relive her sexual assaults as means of healing.

One of the therapists, Richard Yensen, whose psychology license had expired years earlier, said he had consensual sex with Buisson after the experimental therapy sessions ended, but while she was still part of the trial. Buisson accused him of sexual assault constituting assault and battery. Canadian police forwarded the case to prosecutors, who opted not to pursue the case.

Buisson had first taken the therapy further by settling near Yensen and his wife, Donna Dryer, the other therapist in the case, who had a bachelor’s degree in psychology. The cards only required that one person per team be a licensed therapist.

At first, Buisson spoke positively about it, and is quoted on the Maps website: “Therapeutic breakthroughs occur at the limit of consent. They pushed me hard, my toes curling up in protest. But every time I fell, they were there… I was literally loved for life.

Buisson then began to criticize his treatment and seek action, beginning with a civil action in 2018 which went to the Supreme Court of British Columbia the following year before being settled out of court.

The complaint filed by the creators of the podcast also alleged that three other patients across the trials had expressed worsening suicidal thoughts and that these were not incorrectly recorded as adverse events. Participants were asked to stop taking antidepressants, and a tried to admit in a hospital psychiatric ward after his mental health deteriorated, although it is understood that this patient stopped his medication suddenly, contrary to the agreement required to take part in the trial.

Maps was criticized on the podcast for taking until 2021 to watch the videos, although he said ties were cut with the therapists in 2018 due to “ethical misconduct”. His protective measures at the time included having two therapists present – ​​although only one had to be licensed – and recording all visits, as well as monitoring study records. But mandatory viewing of all videos was not in place, and Buisson obtained the video years later, after requesting it from Maps.

“The feelings of love and trust that can be induced by MDMA may make patients more vulnerable to sexual pressure,” Maps founder Rick Doblin wrote in his 2000 doctoral dissertation.

Maps, which has a detailed study safety protocol, first publicly recognized the episode in May 2019 after Buisson spoke. The organization said its code of ethics prohibiting sex between therapists and patients had been violated, although it said it had seen nothing at the time to suggest the code was being violated. He gave Buisson $15,000 to get therapy while his lawsuit was pending and announced he had cut ties with the two therapists.

Last week, the Canadian Drug Policy Coalition – a group that represents more than 50 organizations across the country – released a statement expressing “unequivocal solidarity” with Buisson and calling on Maps and its Vancouver-based affiliate Maps Canada to publicly take responsibility for causing damage.

Betty Aldworth, director of communications at Maps, said: “Any treatment involving the treatment of trauma can lead to worsening of symptoms. Knowing all of this, we have worked to develop a treatment protocol that supports most participants within the limitations of clinical trials, but we look forward to the day when MDMA-assisted therapy can be approved and clinicians can collaborate with patients to individualize the moment. treatments and integration approaches.

Despite multi-million dollar companies like the American Atai Life Sciences and compass paths go public on the Nasdaq As authorities loosen controls on psychedelic drug research, some psychedelic drug advocates are increasingly concerned that drugs such as MDMA, psilocybin and LSD are being touted as panaceas before the research into the best ways to treat vulnerable patients is complete.

“Maps tries to be too many things,” said a psychotherapist who worked on Maps MDMA trials and does not want to be named for fear of professional backlash. “They need to slow down and focus on the research that’s actually happening, and do quality long-term follow-ups while listening and caring about their trial participants when they say, ‘I need ‘additional support’.

David Nickles, an expert on the fledgling psychedelic industry and co-creator of the podcast, called on the US Food and Drug Administration to also review all MDMA trials.

“I’m concerned that the regulatory bodies involved in overseeing this research are not addressing the psychotherapeutic aspect of clinical trials of MDMA,” he said. “A full audit of all video footage and trial data is required, with particular attention to psychotherapy.”

The podcast team said The cards gave them “more than five conflicting answers about who watched the videos and when.”

Aldworth said: “Based on the information I had at the time, I incorrectly stated that no one at MAPS had reviewed the participant videos. When I became aware of the error, I have sent a correction updating our response. During the trial, part of a video was reviewed but did not report concerns of an ethical violation. I regret the error and the distress that our lack of clarity caused to the participant.”

She added that Maps offers unlimited additional onboarding sessions in the months between the final session and the final study visit.

A Health Canada spokesperson confirmed that the complaint prompted it to review all previously authorized clinical trial applications involving MDMA. He says he requested additional information from Maps specifically regarding adverse events, efficacy data and participant complaints.

“The ministry will take appropriate action if necessary if deficiencies or non-compliances are found,” the spokesperson said, adding that complaints were rare and reiterating the government’s commitment to reducing mental illness across the country. .

The government review is expected to be completed next month. Potential actions could include suspending or canceling trials if Health Canada determines an immediate safety risk to participants. It can also enter breaches of the Food and Drugs Act to the public prosecutors.

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