The Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC) is expanding its groundbreaking MDMA-assisted therapy for post-traumatic stress disorder (PTSD) trial into Canada.
Results from the parent Phase 3 trial (MAPP1) released in May demonstrated that MDMA-assisted therapy is an effective treatment for severe, chronic PTSD. 88% of participants experienced a clinically meaningful reduction in their PTSD symptoms, and 67% no longer qualified for a PTSD diagnosis.
Through a partnership with psychedelics-focused mental health care company Numinus Wellness, the trial — titled a multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX) — will be carried out at two Health Canada compliant clinics located in Montreal, Quebec, and Vancouver, British Columbia.
The trial will be open to eligible participants who were previously enrolled in the placebo arm of the parent study or those who were unable to receive treatment due to COVID-19 restrictions.
Under the leadership of MAPS PBC as the study organizer, Numinus Wellness will manage the two Canadian MAPPUSX sites and financially support costs related to therapists who deliver MDMA-assisted therapy at the clinics during the trial. To date, 25 Numinus Wellness-affiliated therapists have undergone the MAPS training program to deliver MDMA-assisted treatment, and some of these therapists will play a role in the trial.
The securing of these two sites by Numinus Wellness will also allow the company to expand its clinical activities in Quebec and British Columbia. This includes the company’s ketamine-assisted psychotherapy program, which is already available in both provinces.
“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,” said Numinus Wellness’ Vice President of Psychology, Dr. Joe Flanders. “We are excited about this study in both British Columbia and Quebec and look forward to how the MAPPUSX study supports expanded collaboration in the future.”
MAPS expects to finish its second Phase 3 MDMA study by October 2022. The non-profit’s Founder and Executive Director Dr. Rick Doblin recently told GQ that he expects it to take another year for MDMA to gain Food and Drug Administration (FDA) approval and Drug Enforcement Administration (DEA) rescheduling.
“We are happy to work with a trusted ally to quickly complete the extension trial at the Canadian sites,” Dr. Doblin said. “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.”
MAPS’ work with MDMA also recently seized the mainstream media spotlight with Iraq veteran Jon Lubecky’s appearance on the Today show. The once-suicidal veteran described how three eight-hour MDMA-assisted therapy sessions under the guidance of MAPS professionals “100% healed” his PTSD.
