A mental health care company in Canada has been given federal approval to conduct a safety and feasibility study evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD).

"We are thrilled that Health Canada has issued its No Objection Letter allowing this important study to proceed and, in doing so, potentially advance Canada toward a legal, regulated system for MDMA-assisted therapy," said Payton Nyquvest, CEO of Numinus.

"We are gratified that our study will provide safety and outcome data to regulators to support integration of this treatment into mainstream mental health care."

This study has advanced through the pre-implementation stage at Numinus‘ Vancouver clinic and has now received the required federal regulatory approval.

Study preparations are now transitioning into the final stages of training staff, importing medication, and obtaining ethical approval to allow the recruitment of participants according to COVID-19 public health protocols.

During the study, research, medical, and therapist staff at Numinus will collect data on the safety and effectiveness of MDMA-assisted therapy to inform Health Canada and support making MDMA-assisted therapy available to individuals living with PTSD in Canada.

Through the collaboration and study activities, Numinus seeks to create access for patients with no other treatment options and establish the physical, human resource and other infrastructure required to scale up access to MDMA-assisted therapy if federal approvals are ultimately in place.

Dr. Devon Christie, Numinus Medical and Therapeutic Services Director, will serve as the study's Qualified Investigator and as a study therapist. Dr. Christie is a family physician with a focus in multidisciplinary pain management and a certified Relational Somatic Therapist.

"Health Canada should be recognized for its ongoing leadership through its support of this study," said Dr. Christie in a statement. "At our Vancouver clinic, we have spent months establishing the physical, technical, clinical, and human resource infrastructure needed to move the study forward and ultimately foster greater access to MDMA-assisted therapy."

In May 2021, MAPS announced results from 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 demonstrated that 88% of participants who received three controlled and supervised MDMA-assisted therapy sessions experienced a clinically significant reduction in symptoms, with 67% no longer qualifying for PTSD diagnosis in comparison to 32% of participants randomized to placebo.

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