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

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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. Following the completion of our Phase I clinical trial in 2022, we are now looking to conduct our Phase II clinical trial for efficacy that runs along with ATMA’s Advanced Psychedelic-assisted Therapy (PaT) Certification Program.

As our Clinical Trials are available only to registered frontline healthcare workers who have completed an approved psilocybin-assisted therapy training program, we invite you to look at our available Training Programs.

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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.

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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.

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Palliative Care

End-of-life anxiety in palliative care patients is extremely prevalent, and conventional methods are not always 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.

There are anecdotal reports and accounts in the non-medical literature regarding the utility of the simultaneous use of psilocybin and MDMA. In order for these reports to be substantiated, both the safety and efficacy of this combination must be tested, as well as proper dosing protocols established; no such study has yet to be conducted. Psilocybin and MDMA confer some synergistic effects, both therapeutic and adverse. For this reason, the full therapeutic dose of each of these medicines, when taken as single agents, is likely not necessary and may potentially increase the risk of adverse events. To establish the optimal dose combination that maintains safety but still produces an effective and unique psychedelic experience, we will be conducting a dose escalation study to assess which dose of MDMA best complements the therapeutic dose of psilocybin.

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).