Investigating psychedelic assisted therapy in Alberta
Pass Herald Reporter
ATMA Journey Centers Inc. (ATMA), an Alberta-based company focused on the international delivery of innovative psychedelic-assisted therapy solutions, announced on September 14 that it has received approval from Health Canada to move forward with its Phase II psilocybin clinical trial. This trial is aimed at studying the potential relief of COVID-19-associated mental health concerns in frontline healthcare providers, as well as documenting healthcare providers' firsthand evaluation of the potential effectiveness of psilocybin psychotherapy in application.
"Health Canada has stated the path forward for psychedelic medicine is through clinical trials," explained ATMA's Chief Scientific Officer, Dr. Michael Blough, "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."
With positive outcomes of clinical trials being published in top-tier medical journals, such as the New England Journal of Medicine, psilocybin-assisted therapy may soon be on the horizon. However, more work is still needed to figure out the protocols for effectively and safely transitioning psilocybin into a real-world clinical setting. After approval of ATMA's Phase I safety trial, conversations began on the goals of a more substantial Phase II trial.
"We spent a significant amount of time discussing which demographics might benefit from psilocybin therapy," stated Blough. "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."
The primary aim of this Phase II trial is to assess the capacity of psilocybin to improve the overall mental health of frontline healthcare providers. Using a variety of self-administered assessments, healthcare providers will assess their levels of anxiety, depression, and occupational burnout before and after the consumption of 25 mg of psilocybin, under the guidance of licensed medical practitioners. This objective will supply data on the effectiveness of psilocybin in a clinical setting. As a secondary goal, participants will complete an assessment of their psilocybin experience to inform the potential use of psilocybin as a therapeutic tool from the perspective of a healthcare provider. ATMA believes its clinical studies will show that psilocybin is safe and effective in treating various mental health issues, laying the groundwork for future trials. However, treatment must be done under the supervision of trained professionals.
"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," stated Dr. Ravinder Bains, ATMA's Chief Medical Officer.
Unfortunately, the current structure of the healthcare system would be prohibitive to this endeavour.
"As we observed, it required four to six hours for participants to return to their baseline physiological and psychological states after psilocybin consumption," continues Bains, "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."
Meeting the requirement of a trained professional is one of ATMA's mandates and relates to the tertiary exploratory outcome of the trial.
David Harder, ATMA CEO, explains that "the need for qualified, certified therapists is becoming increasingly evident, as we see that these medicines must be given in protocols of pre- and post-treatment counselling. Understanding the nature of psilocybin therapy may prove more effective when the training includes an experiential component."
Psilocybin-assisted therapy is quite different from other medicines and requires a unique understanding compared to regular prescription medications. By gaining this understanding, healthcare providers may be able to provide more effective personalized treatments. ATMA plans to collaborate with clinics across Canada, which will provide clinical trial sites that are geographically accessible to healthcare professionals, minimizing excessive travel requirements.
Harder explained, "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."
While ATMA will be running its Advanced Psychedelic Training Program with this trial, allowing for the cross participation of healthcare professionals, other Canadian-based companies, such as Therapsil, will offer similar training. Healthcare professionals from either training program will be able to take part in this trial should they meet the requirements. For more information on ATMA's clinical trials and training programs, visit atmajourney.com.
Harder added that "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."