By Psychedelics Company Gets Green Light for PTSD Therapy Study Using MDMA in Canada
A mental health care company in Canada received federal approval to conduct a safety and feasibility study evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD).
“We are delighted that Health Canada has issued its Letter of No Objection allowing this important study to continue and, in doing so, potentially moving Canada toward a legal and regulated system for MDMA-assisted therapy,” said Payton Nyquvest, CEO of Numinus. .
“We are pleased that our study provides safety data and results to regulators to support the integration of this treatment into mainstream mental health care.”
This study has advanced through the pre-implementation stage in can‘Vancouver Clinic and has now received the required federal regulatory approval.
Study preparations are now moving to the final stages of staff training, drug importation, and obtaining ethical approval to enable recruitment of participants in accordance with COVID-19 public health protocols.
During the study, Numinus research staff, physician and therapist will collect data on the safety and efficacy of MDMA-assisted therapy to inform Health Canada and support that MDMA-assisted therapy is available to people living with PTSD. in Canada.
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Through collaborative and research activities, Numinus seeks to create access for patients with no other treatment options and establish the physical, human resource, and other infrastructure needed to expand access to MDMA-assisted therapy if federal approvals are finally met. current.
Dr. Devon Christie, director of medical and therapeutic services for Numinus, will act as a qualified study investigator and as a study therapist. Dr. Christie is a family physician with a focus on multidisciplinary pain management and a certified somatic relational therapist.
“Health Canada should be recognized for its continued leadership through its support of this study,” said Dr. Christie. in a sentence. “At our Vancouver clinic, we have spent months establishing the physical, technical, clinical and human resource infrastructure necessary to advance the study and ultimately foster greater access to MDMA-assisted therapy.”
New test builds on robust MAPS phase 3 results
In May 2021, MAPS announced the results of its Phase 3 randomized clinical trial that confirmed the substantial efficacy and safety of MDMA-assisted therapy for PTSD under the MAPS Public Benefit Corporation (MAPS PBC) protocol.
The trial showed that 88% of participants who received three supervised and controlled MDMA-assisted therapy sessions experienced a clinically significant reduction in symptoms, and 67% no longer qualified for the diagnosis of PTSD compared to 32% of participants randomized to placebo.
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