ATMA Journey Centers Inc. has been granted a No Objection Letter by Health Canada, a crucial step towards opening ATMA’s first sponsored clinical trial.
| CALGARY, AB, Jan. 7, 2022 /CNW/ - ATMA Journey Centers Inc. (“ATMA”) has been granted a No Objection Letter (“NOL”) by Health Canada, a crucial step towards opening ATMA’s first sponsored clinical trial. The trial participants are licensed health care providers enrolled in a psychedelic-assisted therapy program. The trial’s primary goal will be to document the safety of synthetic psilocybin when administered to healthy participants in a controlled clinical setting. The secondary exploratory approach of the trial will be to assess the psychological outcome, documented by self-administered assessments before and after the experiential psilocybin session. The trial will begin in mid-2022, led by psychiatrist and Chief Medical Officer of ATMA: Dr. Ravinder Bains. “Health care providers who meet our inclusion criteria will enrol in the trial after careful screening and assessment,” states Dr. Bains. “Further, after administration of psilocybin during the experiential session, we will be documenting heart rate, body temperature, blood pressure, and monitoring for irregular heartbeat via ECG.” Dr. Bains has stated that he does not expect any long-term or serious adverse events based on published literature. Still, it will be essential to acquire this primary safety data with healthy individuals as a baseline for future studies with psilocybin. “There is a growing body of evidence in reputable medical journals that psychedelic medicine, and specifically psilocybin, has very significant efficacy in treating a variety of mental health issues. We [ATMA] believe this approach will offer much hope to patients suffering from mental health issues that have been untreatable, but believe it is crucial to begin this journey to treatment with basic safety data.” In addition to demonstrating the safety of psilocybin in a clinical setting, study investigators and participants will gain a greater appreciation of the effects and intended therapeutic applications of the medicine via psychological assessments. Once enrolled, participants will complete self-administered basic assessments of psychological well-being, which will then be repeated two days after their experiential session. “These exploratory assessments of the trial will allow us to compile additional data regarding the psychological outcome of psilocybin treatment in healthy individuals,” continues Dr. Bains. “The fact that the participants are health care providers that deal daily with patients with serious mental health issues will provide a unique first-hand perspective on the potential of psychedelic-assisted therapy.” The regulatory environment surrounding psychedelic medicine in Canada has become increasingly receptive to progression, as evidenced by recent amendments to the Special Access Program, released January 4, 2022, allowing physicians to request psychedelic medicine on behalf of eligible patients. With sufficient clinical and scientific evidence, together with the NOL granted to ATMA, Canadian policymakers and healthcare professionals are receptive to the therapeutic potential of psychedelic medicine. “With the studies that have already been done, and based on increasing clinical evidence, the future of psychedelic medicine is becoming a reality as a viable therapy,” states David Harder, co-CEO of ATMA. “While the access of psychedelic medicine for patients will continue to be something we all work towards, we are optimistic that with ongoing research and clinical trials, 2022 is going to be a banner year in seeing these novel and effective treatment options become an important tool of therapy for many therapists and medical professionals.” ABOUT ATMA JOURNEY CENTERS INC. SOURCE ATMA Journey Centers Inc |