Numinus given ‘go-ahead’ for MDMA study.
A mental health care company in Canada has been given federal approval to conduct a study evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD). Psychedelics can help people curb opioid addiction as well as ease symptoms of PTSD, anxiety, and depression. However, this therapy still controversial and has not been widely approved.
“This is really kind of a new zeitgeist in psychiatry,” explained Barbara Rothbaum, a clinical psychologist at Emory University. Countries other than the U.S., however, have been more progressive in their approval of psychoactive drugs for clinical use.
“It’s not understood what the role of MDMA or [another] psychedelic is in facilitating the psychotherapy, and what’s happening neurobiologically,” said Atheir Abbas, a neuroscientist and psychiatrist at Oregon Health & Science University. “Because taking psychedelics without guidance can lead to negative experiences, a guided, more psychotherapy-oriented approach is probably warranted. But it’s not clear what aspects of that guidance are critical.”
The drug is known to increase the brain’s neurotransmitters, including serotonin and dopamine, which leads to a general sense of well-being, without vivid hallucinations of other psychedelic drugs.
Payton Nyquvest, CEO of Numinus in Canada, responded to the federal approval by saying, “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. 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.”
The team is in the final stages of preparing to conduct the study, including training staff, obtaining medication, and obtaining ethical approval to seek participants while keeping up with public health protocols during the pandemic. When the study officially commences, Numinus will be collecting data on the safety and effectiveness of MDMA-assisted therapy to inform Health Canada.
In the U.S., the nonprofit agency Multidisciplinary Association for Psychedelic Studies (MAPS) has been working for more than 30 years to allow MDMA into a prescription medicine. “It gives you this fascinating ability toward self-compassion,” said Jennifer Mitchell, a neuroscientist at the University of California, San Francisco, and an investigator in the MAPS trial.
In May of this year, MAPS announced results from its Phase 3 randomized clinical trial, showing “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.”
Numinus is creating access for patients with no other treatment options available. Dr. Devon Christie, Numinus Medical and Therapeutic Services Director, is the study’s Qualified Investigator and therapist. Christie is a family physician with a focus in pain management,and a certified Relational Somatic Therapist.
“Health Canada should be recognized for its ongoing leadership through its support of this study,” said Christie. “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.”