A new clinical initiative aimed at improving the mental well-being of frontline workers with trauma related to the COVID-19 pandemic will soon be underway in Alberta.
On Wednesday, ATMA Journey Centers announced that it had been granted Health Canada approval to proceed with its N500 phase II psilocybin clinical trial.
The study will assess levels of depression, anxiety and occupational burnout in healthcare workers before and after ingesting 25 milligrams of psilocybin.
ATMA is known for being the first private company in Canada to undertake legally approved psilocybin-assisted therapy. The organization says it provides a path for healthcare professionals and clinics to integrate psychedelic medicines into their current practices.
“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,” explained Dr. Michael Blough, Chief Scientific Officer for ATMA.
Following the approval of ATMA’s successful phase I safety trial, a conversation ensued regarding potential objectives for a more sizeable phase II trial and a great deal of time was spent discussing which demographics could reap the benefits of psilocybin therapy.
“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. While enduring the pandemic has been difficult for all Canadians, healthcare providers have had the unique challenge of helping patients cope with both the direct and indirect physical and psychological burdens of COVID-19,” said Dr. Blough.
The organization also emphasizes the importance of professional supervision with studies such as these and says that psilocybin therapy is quite different from other varieties of medicine and requires greater attention than conventional treatments.
“While transient, expected adverse events were observed in our phase I trial, including temporary increase in blood pressure and altered psychological states, medical intervention was unnecessary. However, patient observation is certainly required after the consumption of psilocybin,” said Dr. Ravinder Bains, ATMA’s Chief Medical Officer.
“As we observed, it required 4-6 hours for participants to return to their baseline physiological and psychological states after psilocybin consumption. It is neither cost-effective nor the best use of a physician’s time for them to spend six hours monitoring a patient in an altered psychological state. We believe training other healthcare providers, such as therapists, nurses, and psychologists, will provide the expertise required for the safe and effective administration of this medicine,” added Bains.
ATMA plans on working with clinics throughout Canada to offer clinical trial sites nationwide in order to minimize travel requirements for healthcare professionals. Study participants will also complete an assessment of their psilocybin experience to help evaluate the potential of the compound as a therapeutic tool from a healthcare provider’s perspective.
“We welcome more physician, clinician, and clinic participation in this historic collaboration of the largest psilocybin clinical trial to date. Physicians, clinicians, and clinics looking to explore psilocybin-assisted therapy as part of their future service offerings could benefit greatly from this trial,” said David Harder, CEO of ATMA.
“ATMA is extremely excited by Health Canada’s approval of this trial. The opportunities that will emerge, the knowledge that will be gained, and the life-improving experiences for healthcare providers that will occur are ultimately what drive ATMA’s pursuit of this medicine.”