MAPS/Numinus Seek Approval for MDMA Trial

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  • Numinus Wellness and the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation will be seeking approval to deliver MDMA-assisted psychotherapy for post-traumatic stress disorder in a compassionate access trial. 
  • If approved, the first-of-its-kind trial in Canada would take place at Numinus’ Vancouver clinic. 
  • It is hoped the trial will improve accessibility to MDMA-assisted therapies. 

Numinus Wellness and the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), have announced that through a collaboration agreement they will be seeking approval to deliver MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) via a single-arm, open-label, compassionate access trial. 

If approved, the trial would be conducted at Numinus’ Vancouver clinic and would provide MDMA-assisted psychotherapy to an initial sample group of 20 individuals experiencing PTSD, as well as collecting outcome and safety data for Health Canada. 

In a joint statement issued by Numinus and MAPS, the companies said Numinus’ physicians, therapists, and staff would be trained to deliver the treatment under MAPS’ clinically-tested PTSD treatment protocol prior to approval by Health Canada. “This clinical trial will be the first-of-its-kind in Canada and will take a meaningful step in furthering the accessibility of MDMA-assisted treatment options for those experiencing PTSD around the world,” the companies said. 

MDMA and the Treatment of PTSD

Research undertaken by MAPS and MAPS PBC into MDMA-assisted psychotherapy was granted “breakthrough therapy” status from the United States Food and Drug Administration (FDA) in 2017. Six Phase II trials of the novel treatment package, which combines psychotherapeutic techniques with three administrations of MDMA, have been completed, and Phase III trials are ongoing. Other psychedelics being tested as possible treatments for PTSD include psilocybin, ketamine, and ayahuasca. 

In the statement, medical director at Numinus and MAPS-trained therapist for the delivery of MDMA-assisted therapy Devon Christie said the collaboration which leveraged MAPS’ evidence-based treatment protocol and Numinus’ clinical infrastructure “will open the door to MDMA-assisted psychotherapy in Canada”. 

MAPS PBC chief executive officer Amy Emerson said training Numinus therapists in the MDMA-assisted psychotherapy protocol for PTSD would provide a meaningful expansion of access to the ongoing research program for this promising treatment. “Though this treatment is still investigational, if approval is granted through the regulatory pathway this collaboration will bolster our shared goal of addressing the enormous, and growing, need for improved proven treatments for people suffering from PTSD,” Emerson said in the statement. 

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MAPS founder and executive director Rick Doblin added that the company was excited to work with Numinus “to build the case for regulatory approval through this compassionate access trial and expand best practice clinical infrastructure.” 

Numinus chief executive officer Payton Nyquvest also expressed his enthusiasm for the collaboration. “We are proud to work alongside MPAS in furthering the regulatory landscape for psychedelic-assisted therapies, including MDMA, and setting the stage for the healthcare system of tomorrow.”

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