Numinus Wellness Inc. (TSX-V:NUMI, OTC:LKYSF) said it has secured two new psychedelic clinics in Canada to host a key study into MDMA-assisted psychotherapy for PTSD (Post-Traumatic Stress Disorder).
The MAPS Public Benefit Corporation (MAPS PBC) study is titled: 'A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX)', the company said.
Numinus will manage the two new clinics, both fully compliant with Health Canada regulations and ready to provide MDMA-assisted therapy as part of the trial. It will also host the Montreal and Vancouver sites in MAPPUSX, which will continue to study the safety and efficacy of MDMA in treating severe PTSD, under the leadership of MAPS PBC as study organizer.
"We are honored to host the Canadian sites of the MAPPUSX trial as we continue to examine the important findings around MDMA-assisted therapy for PTSD," said Dr Joe Flanders, VP, Psychology at Numinus and therapist for the Montreal site of the trial in a statement.
"Our clinical and research teams are well positioned to implement MAPS' research and, ultimately, to work with MAPS on the translation of research findings into mainstream clinical practice. We are excited about this study in both BC and Quebec and look forward to how the MAPPUSX study supports expanded collaboration in the future," added Flanders.
Numinus will financially support costs relating to therapists who deliver the therapeutic intervention in the clinics during the trial.
MAPS is a non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.
“We are thrilled that our two new locations, which are purpose-developed for psychedelic-assisted therapy, regulatorily compliant and leading in industry standards, can be used to help advance this crucial work on psychedelic medicine. We look forward to deepening our collaboration with MAPS while expanding the resources and solutions available to those suffering from PTSD," said Numinus CEO Payton Nyquvest.
To date, 25 Numinus-affiliated therapists have gone through MAPS' training program for delivery of MDMA-assisted therapy and a number of these therapists will have roles in the trial. The trial will be open to eligible participants who were previously enrolled in the placebo arm of the parent study (MAPP1) or who were not able to receive treatment due to coronavirus (COVID-19) restrictions.
"We are happy to work with a trusted ally to quickly complete the extension trial at the Canadian sites" said Dr Rick Doblin, the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS).
"As we get closer to our goal of making MDMA-assisted therapy a reality, it is critical that we work with clinics who will advance making this treatment widely accessible in real-world settings," he added.
Numinus has assumed the leases of the Vancouver and Montreal psychedelic-assisted psychotherapy clinics that were previously used to conduct MAPS PBC's earlier study, which was a multi-site phase 3 study of MDMA-assisted psychotherapy for PTSD (MAPP1). In that trial, 88% of participants experienced a clinically meaningful reduction in symptoms and 67% no longer qualified for a PTSD diagnosis. The highly statistically significant results and excellent safety record suggest MDMA-assisted therapy will be an effective treatment for severe, chronic PTSD.
Securing the Canadian sites will further allow Numinus to expand its clinical activities in Quebec and British Columbia, including its ketamine-assisted psychotherapy program.