Numinus Wellness (NUMI.T) has moved into the implementation part of their MDMA-assisted psychotherapy trial for post-traumatic stress disorder (PTSD) clinical trial by enrolling and dosing its first volunteer.
Numinus plays host to the study through its Montreal and Vancouver clinics. This week, the Montreal site began administering the drug. The treatment follows MAPS’s protocol of three sesssions of MDMA administration and therapy, followed by three integration sessions. The entire program should be finished by midsummer 2022.
“We are proud of our clinical and research teams who have been and continue to be instrumental in driving MDMA-assisted therapy for PTSD research forward in Canada,” said Payton Nyquvest, chief executive officer and founder, Numinus. “This week’s trial progress is another step in our strengthening collaboration with MAPS as we work together to make psychedelic-assisted therapy accessible to those in need. We will continue to work with MAPS, Health Canada and the industry to help make MDMA-assisted therapy a reality.”
Estimates from the Canadian Health Association are that about 8% of Canadians who experience a traumatic event develop PTSD. In Canada, the lifetime prevalence rate of the disorder is 9.2%.
It typically manifests with four symptoms:
- Intrusions, including continually re-experiencing the event through intrusive thoughts or unwanted dreams.
- Avoiding stimuli related to the traumatic event, either consciously or unconsciously.
- Negative cognitions or mood related to oneself or the world around them.
- Hyperarousal, including irritability, difficulty sleeping, feeling constantly on guard.
The trial is an extension of MAPS’s phase three studies conducted to investigate the safety and efficacy of MDMA-assisted therapy on PTSD. It’s open to participants from phase three studies who received placebo last time, and those who couldn’t get treatment thanks to COVID-19. The data will go to regulatory bodies in the sponsors drug application.
“Numinus is excited to administer the first MDMA-assisted therapy dosing of MDMA at our clinics and contribute to the growing body of MAPS’s research. Designed with accessibility and ethics at its core, we look forward to the continuation of this study and translating the findings into clinical practice,” said Dr. Flanders.
—Joseph Morton
