Alberta-based ATMA Journey Centers Inc. has received Health Canada’s approval to move forward with its N500 Phase II psilocybin clinical study investigating the potential relief of COVID-19-associated mental health challenges in frontline healthcare professionals while documenting their firsthand evaluation.
ATMA’s R&D is focused on advancing a therapist-centered and therapist-driven business model for the psychedelic industry, offering education, training, clinical trials and business support to mental healthcare professionals wishing to adopt psychedelic-assisted therapy as part of their services.
"Health Canada has stated the path forward for psychedelic medicine is through clinical trials," CSO Dr. Michael Blough explained. "ATMA's clinical trial platform aims to provide policymakers with the real-world data they require to make informed decisions regarding the future of psychedelic medicine in Canada."
After the Phase I safety trial’s success, the company was aiming for a more substantial and demographically-specific Phase II psilocybin study. "We unanimously decided that the pandemic has tremendously impacted frontline healthcare providers, and as such, they should be our first foray into testing the efficacy of psilocybin in treating mental health concerns," said Blough.
As it is conceived, this study is set to contribute to determining the protocols for effectively and safely transitioning psilocybin into real-world clinical settings, while also providing a self-informed assessment of the psilocybin therapeutic experience from the perspective of healthcare providers.
Study volunteers will self-measure their levels of anxiety, depression and occupational burnout before and after taking 25mg of psilocybin combined with therapy. The assessments will include the Quick Inventory of Depressive Symptomatology Self-Report 16-item (QIDS-SR16), the Generalized Anxiety Disorder 7-item (GAD-7), and the Burnout Assessment Tool (BAT).
For the trial, ATMA aims to collaborate with different clinics across Canada, welcoming all but especially those physicians, clinicians and clinics looking to explore psilocybin-assisted therapy as part of their future service offerings.
Further, ATMA will run an advanced psychedelic training program concurrent to the Phase II study. Healthcare professionals interested in learning how to provide this treatment will be allowed to cross-participate, whether enrolled in ATMA’s or in Therapsil’s therapy training.
The Phase II study is also set to explore the impact it might produce in healthcare professionals’ work to first experience psilocybin therapy and later provide it. "Understanding the nature of psilocybin therapy may prove more effective when the training includes an experiential component," concluded CEO David Harder.
ATMA’s Phase I trial showed “transient, expected adverse events,” including a temporary increase in blood pressure and altered psychological states. While no medical intervention was required, ATMA’s CMO Dr. Ravinder Bains stated that “patient observation is certainly required after the consumption of psilocybin."
This task could potentially get hampered, considering the healthcare system’s current structure: ATMA’s Phase I study showed that it required 4-6 hours for participants “to return to their baseline physiological and psychological states” after taking the psilocybin dose.
As Dr. Bains stated, this amount of time would be “neither cost-effective nor the best use of a physician's time.” This is why ATMA is beginning to train other healthcare providers, including therapists, nurses, and psychologists, to safely and effectively administer the therapeutic.
Photo by Usen Parmanov on Unsplash
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