Health Canada Provides a No Objection Letter to ATMA’s N500 Phase II Clinical Trial Application, Paving The Way For The Largest Psilocybin Trial To Date

ATMA Journey Centers Inc. (“ATMA”), an Alberta-based company focused on the international delivery of innovative psychedelic-assisted therapy solutions, announced today that it has received approval from Health Canada to move forward with its N500 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.

Indeed, with positive outcomes of clinical trials being published in top-tier medical journals such as the New England Journal of Medicine, JAMA, and LANCET, psilocybin-assisted therapy may soon be on the horizon. However, more work is still required to determine 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 objectives of a more substantial Phase II trial. “We spent a significant amount of time discussing which demographics might benefit from psilocybin therapy,” states Dr. 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 objective 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, including 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), healthcare providers will assess their levels of anxiety, depression, and occupational burnout before and after the consumption of 25mg psilocybin, under the guidance of licensed medical practitioners. The outcome of this objective will provide real-world data as to the effectiveness of psilocybin in a clinical setting. As a secondary exploratory objective, participants will complete an assessment of their psilocybin experience to inform the potential utility of psilocybin as a therapeutic tool from the perspective of a healthcare provider.

Looking forward, ATMA believes its clinical studies will demonstrate that psilocybin is safe (Phase I) and effective (Phase II) in treating various mental health issues, laying the groundwork for future trials. However, it has become clear that 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,” states Dr. Ravinder Bains, ATMA’s Chief Medical Officer. Unfortunately, the current structure of the health care system would be prohibitive to this endeavour. “As we observed, it required 4-6 hours for participants to return to their baseline physiological and psychological states after psilocybin consumption,” continues Dr. 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 counseling. Understanding the nature of psilocybin therapy may prove more effective when the training includes an experiential component.” Indeed, psilocybin-assisted therapy is very different from other medicines and requires a unique understanding compared to conventional pharmacological interventions. By gaining this understanding, both from the physiological and psychological perspective, 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.  Mr. Harder adds, “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 concurrent to this trial, allowing for the cross participation of healthcare professionals interested in pursuing the path of psychedelic-assisted therapy in the near future, other Canadian-based companies, such as Therapsil, will offer similar training. Healthcare professionals from either training program will be able to participate in this trial should they meet the clinical trial requirements. For more information on ATMA’s clinical trials and training programs, visit https://www.atmajourney.com/.

Mr. Harder exclaims 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.”

ATMA is pioneering a therapist-centred and therapist-driven business model for the psychedelic industry by building the largest online community platform for psychedelic practitioners. Education, training, clinical trials, and business support services are all being developed to assist mental healthcare professionals in adopting psychedelic-assisted therapy. Our philosophy of inclusivity will encourage increased participation from healthcare professionals, which will in turn, yield more data and experiences.

Overall, this will lead to increased effectiveness and accessibility of psychedelic-assisted therapy. Beginning with a clear focus on psilocybin-assisted therapy, we will be able to expand to other psychedelics as the regulatory environment also expands.

ATMA provides a clear, guided path for healthcare professionals and clinics to build psychedelic-assisted therapies into their current practices.