July 18: Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review

July 18: Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review
CANNANNEW REPORT

CBC Canada Patient safety concerns uncovered during an ongoing federal review have led to the suspension of one of two clinical trials for MDMA-assisted psychotherapy currently underway in Canada. The Phase II trial in Toronto, sponsored by a mental health charity called the Remedy Institute, was issued a non-compliant rating on June 22, according to Health Canada. A spokesperson told CBC in an email that the study was put on hold “due to concerns for participant safety.” The federal regulator’s summary of a June 6 inspection identifies 12 concerns with 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. The report card also says that medical care for the patients involved was happening without supervision from a qualified investigator. Anne Wagner, founder of the Remedy Institute and an adjunct professor of psychology at Toronto Metropolitan University, said her organization had believed they were compliant with Health Canada regulations, but they now understand changes are necessary. “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 wrote in an email. She said 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,” Wagner said. 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 alleged sexual misconduct by two investigators in Vancouver, potential flaws in the research conducted to date and reports of increased suicidal thinking from some patients. Inspectors are still finalizing their…

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Source : July 18: Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review

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