ATMA Submits N500 MDMA Phase II Trial Application To Health Canada

ATMA Journey Centres Inc. (ATMA), Canada's leading psychedelic-assisted therapy training provider, announced that it has submitted to Health Canada a N500 3,4-Methylenedioxymethamphetamine (MDMA) phase II Clinical Trial Application (CTA), which aims to assess the efficacy of MDMA in treating mental health issues in frontline healthcare workers, as well as provide subjective documentation of its clinical utility. This will be the most extensive MDMA clinical experiment ever conducted. Healthcare personnel, like the general population, suffer from psychological trauma, anxiety, depression, and burnout.

However, evidence suggests that because of the nature of their frontline work on a daily basis, they face these mental health difficulties to a far greater extent than the general public. From compassion fatigue to vicarious traumatization, as well as personal mental health issues, frontline healthcare personnel have generally learned to bury their pain and operate with it in their daily lives. Many frontline healthcare workers, in fact, have unintentionally adapted to burnout. ATMA's mandate includes evaluating the therapeutic efficacy of psychedelic medicine in the treatment of certain mental health disorders.

ATMA's Health Canada-approved phase II psilocybin trial is expected to begin in the summer of 2023. Students are enthused about the prospect of participating in this experiment as ATMA's first cohort of 80+ graduates nears completion of the Advanced Psychedelic-Assisted Therapy Training course. Enrollment will begin following clearance from the Health Research Ethics Board of Alberta (HREBA). The primary goal of the N500 clinical trial is to investigate the efficacy of psilocybin in the treatment of generalised anxiety disorder, major depressive disorder, and occupational burnout syndrome in frontline healthcare professionals who have been negatively impacted by stressful work conditions as a result of Covid-19.

The secondary goal of this study is to provide insights into the utility of this medicine as a therapeutic tool from the standpoint of healthcare professionals engaged in this line of work. While psilocybin may be effective in treating the aforementioned mental health concerns, MDMA may also be a viable therapeutic option. As Australia moves towards the legalisation of both psilocybin and MDMA for clinical use, and Canada is expected to follow suit, there is a clear need for a large-scale MDMA clinical trial; this is necessary in order to provide the necessary data to support clinical implementation and protocol development, as well as to provide healthcare professionals with the opportunity to gain a better understanding of the utility of MDMA as an adjuvant therapeutic agent, in the same way that psilocybin and MDMA are.

ATMA's phase II MDMA experiment is very similar to their N500 psilocybin trial in that frontline healthcare professionals with proven mental health disorders will conduct self-administered psychological assessments before and after treatment to document the efficacy of MDMA as a therapeutic agent. Additionally, ATMA will solicit participant comments on the possible clinical value of MDMA. The experience of seeing other participants who are under the influence of MDMA will be a tertiary outcome of the research, which may help healthcare practitioners comprehend how MDMA-assisted therapy could be effective in a legal, therapeutic context. “We are excited to begin collecting data and hearing the perspective of healthcare professionals participating in our clinical trials using putative psychedelic therapeutics,” states Dr Ravi Bains, ATMA’s chief medical officer. “To then be able to compare the data and experiences of healthcare professionals undergoing psilocybin versus MDMA treatment for similar indications will be crucial to determining the clinical utility of these compounds.” “We believe that the data coming out of these clinical trials will be invaluable to both the development of this field and our community of psychedelic practitioners,” states Vu Tran, Founder of ATMA. “Practitioners sharing their personal experiences with their peers will also help to innovate best practices and establish sound protocols for the effectiveness of psychedelic-assisted therapy.”

“As psychedelic-assisted therapy nears legal status globally, Health Canada will be seen by the world as a progressive leader in psychedelic medicines, for making these types of clinical trials available to healthcare professionals who are training in this field,” Tran adds. “As a result, more effective practitioners and leaders will emerge in the Canadian psychedelic industry.” ATMA’s programmes and trials are open to international healthcare professionals who meet the exclusion and inclusion criteria. Graduates of MAPS, CIIS, and other qualifying advanced psychedelic programs are also welcome. ATMA is pioneering a therapist-centred and therapist-driven business model for the psychedelic industry. Education, training, clinical trials, and business support services are all being developed for the largest community of psychedelic practitioners, to assist mental healthcare professionals in adopting psychedelic-assisted therapy into their practices.