Canadian company obtains federal approval for MDMA and PTSD study –

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Numinus has been given the green light for the MDMA study.


A mental health care company in Canada has received federal approval to conduct a study evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD). Psychedelics can help people fight opioid addiction and relieve symptoms of PTSD, anxiety, and depression. However, this therapy remains controversial and has not been widely approved.

“He’s really kind of a new zeitgeist in psychiatry,” explained Barbara Rothbaum, clinical psychologist at Emory University. Countries other than the United States, however, have been more progressive in approving psychoactive drugs for clinical use.

“We do not understand what is the role of MDMA or [another] psychedelic is to facilitate psychotherapy and what’s going on neurobiologically, ”said Atheir Abbas, neuroscientist and psychiatrist at Oregon Health & Science University. “Because taking psychedelics without counseling can lead to negative experiences, a guided and more psychotherapy-oriented approach is probably warranted. But it is not clear which aspects of this orientation are critical.

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The drug is known to increase neurotransmitters in the brain, including serotonin and dopamine, which leads to a general feeling of well-being without the vivid hallucinations of other psychedelic drugs.

Payton Nyquvest, CEO of Numinus in Canada, responded to the federal approval by stating: “We are delighted that Health Canada has released its letter of no objection allowing this important study to continue and in doing so, move forward. potentially Canada towards an MDMA assisted therapy system. We are excited that our study is providing safety and outcome data to regulators to support the 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 medications, and obtaining ethical approval to search for participants while adhering to protocols. public health during the pandemic. When the study officially begins, Numinus will collect data on the safety and effectiveness of MDMA-assisted therapy to inform Health Canada.

In the United States, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) has worked for more than 30 years to make MDMA a prescription drug. “It gives you this fascinating capacity for self-compassion,” said Jennifer Mitchell, a neuroscientist at the University of California, San Francisco and a researcher in the MAPS trial.

In May of this year, MAPS announced the results of its Phase 3 randomized clinical trial, showing that “88% of participants who received three sessions of controlled and supervised MDMA-assisted therapy experienced a clinically significant reduction in symptoms, 67% no longer qualifying for PTSD. diagnosis compared to 32% of participants randomized to receive a placebo. “

Numinus creates access for patients with no other treatment option available. Dr Devon Christie, director of medical and therapeutic services at Numinus, is the qualified investigator and therapist for the study. Christie is a family physician specializing in pain management and a Certified Relational Somatic Therapist.

“Health Canada should be recognized for its continued leadership through its support of this study,” said Christie. “At our Vancouver clinic, we spent months putting in place the physical, technical, clinical and human resource infrastructure necessary to move the study forward and ultimately foster greater access to assisted therapy. by MDMA.

Sources:

Psychedelic company gets green light for study into PTSD therapy using MDMA in Canada

Psychedelic medication can help treat PTSD. But questions remain about how best to use and regulate

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