🎉 Health Canada Provides a No Objection Letter for ATMA’s N500 Phase II Clinical Trial Application

Announcement

On September 13, 2022, ATMA received the NOL from Health Canada for the Phase II N500 clinical trial for psilocybin. Following the Ethic’s Board approval process, which is expected to be about 90 days, information regarding enrollment will be posted to the ATMA website. Please continue to check the website for updates and details as they become available.

Evaluating safety and efficacy with our psilocybin trials

As part of our initiative to move psilocybin toward legalization, we are working with Health Canada to conduct multiple clinical trials evaluating its safety and efficacy. View our current clinical trials based in our Calgary, Alberta office.

Phase I

A Phase I Study with the intent to assess the safety of psilocybin when administered to healthy participants. This clinical trial for psilocybin-assisted therapy will evaluate the safety and tolerability of psilocybin in the healthcare practitioners.

Phase II

A Phase II Study with the intent to assess the efficacy of psilocybin when administered to frontline healthcare workers with COVID-19-related mental health concerns.

Palliative Care

End-of-life anxiety in palliative care patients is extremely prevalent, and conventional methods are not sufficient in treating such anxiety. Psilocybin-assisted therapy not only holds the promise of high levels of efficacy, but also allows for patients to discover personal insights in a shorter period of time than conventional methods, which is crucial for palliative care patients whose time is limited.

It is important for this population of patients to have access to this medicine, and the evaluation of safety and efficacy of psilocybin in this population will move it closer to legalization. This is a psychedelic clinical trial that we plan to undertake in the near future.

Terminal cancer patient Tony White is the first Albertan to have undergone legal psychedelic therapy in Canada since Health Canada started allowing palliative care patients to take magic mushrooms to relieve end-of-life distress last year.

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Bio-disasters, such as SARS, MERS, and now COVID-19, produce an unparalleled strain on frontline healthcare workers. By analyzing the long-lasting impact of prior bio-disasters on mental health, it is evident that a novel approach must be taken to address the resulting mental health concerns of frontline physicians, nurses, psychologists, psychiatrists, etc. from COVID-19. This Phase II Study’s primary objective is to demonstrate the efficacy of psilocybin in frontline healthcare professionals who are suffering from COVID-19-related mental health concerns, including major depressive disorder, generalized anxiety disorder, and/or occupational burnout. Standardized questionnaires – QIDS-SR16, the Generalized Anxiety Disorder 7-item (GAD-7), and the Burnout Assessment Tool (BAT) – will be administered to participants prior to and after the psilocybin session to assess improvement in mental state. The secondary exploratory outcome for this study will be the completion of a survey following the experiential session, which will document how effective healthcare professionals believe psilocybin is as a therapeutic tool, based on their firsthand experience.

This is the first clinical trial of its kind, evaluating 20 healthy healthcare practitioners. As psilocybin-assisted therapy nears legalization, there is the ever-growing need for healthcare practitioners to understand the psychedelic state thoroughly and completely, which is only achievable via firsthand experience. This firsthand experience will allow for practitioners to gain comprehensive insights into the medicine they will eventually be administering to their patients. The primary objective of this trial is to demonstrate the safety and tolerability of psilocybin in these healthy healthcare practitioners. In order to be considered for this study, participants must be deemed to be in good mental and physical health as assessed by a physician.  The secondary exploratory objective is to evaluate the general nature of the subjective effects occasioned by the consumption of psilocybin, via standardized self-assessment questionnaires (the Quick Inventory of Depressive Symptomatology Self-Report 16 – QIDS-SR16, and the Revised Mystical Experience Questionnaire – MEQ-30).