Evaluating safety and efficacy with psilocybin clinical trials
As part of our initiative to provide efficacy data to health authorities as well as to demonstrate the utility of psychedelic medicines to healthcare professionals, we are working with Health Canada to conduct multiple clinical trials evaluating the safety and efficacy of psilocybin and MDMA in a therapeutic setting.
Qualifiers
Who can participate in psilocybin and MDMA clinical trials?
Our Clinical Trials are available to registered frontline healthcare workers who have completed an approved Advanced PaT Certification Program. Participants must meet eligibility criteria. Contact us to discuss your participation.
Phases
Psilocybin Clinical Trial Phases
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 evaluated the safety and tolerability of psilocybin in the healthcare practitioners.
This was ATMA’s first clinical trial, 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 allowed for practitioners to gain comprehensive insights into the medicine they will eventually be administering to their patients. The primary objective of this trial was to demonstrate the safety and tolerability of psilocybin in these healthy healthcare practitioners. In order to be considered for this study, participants were required to be in good mental and physical health as assessed by a physician. The secondary exploratory objective was 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).
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.
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.
N500 MDMA Phase II Clinical Trial Application for Healthcare Professionals
But wait, there’s more!
Psychedelic-Assisted Therapy Clinical Trials News & Articles
Read more about clinical trials and the latest findings in psychedelic-assisted therapy research.
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