Health Canada receives applications regularly about clinical studies. This time the licensed producer of natural EU-GMP psilocybin and MDMA Optimi Health Corp. OPTHF along with ATMA Journey Centers they say intend to submit a Phase I Application for Clinical Trials (CTA) to document the safety of Optimi’s natural psilocybin biomass and MDMA in healthy patients.
The study plans to assess both safety – blood pressure, temperature, heart rate, ECG readings – and additional markers – ie a mystical experiential questionnaire – in healthy subjects after taking the proprietary formulation of natural psilocybin and MDMA.
Optimi’s CEO Bill Ciprick expressed his zeal To begin this study: “For the thousands of trained professionals waiting to experience natural EU-GMP psilocybin and MDMA, we share their excitement and believe we have one to deliver ethical responsibility them with a life-changing product that is making a huge impact attention from regulators around the world.”
On behalf of ATMA, CEO David Harder accepted the importance of the CTA context and reiterated the company’s commitment to the construction of a therapist-centered and therapist-driven support and training approach.
Harder believes clinical evidence is through experiential learning about the action of these molecules “is critical to delivering a robust training program for therapists to prepare for the need that is already on our doorstep.”
The current partnership is set to expand on the relationship between the two companies, which began with a Psilocybin Supply Agreement earlier in 2022. In it, Optimi will portray the official sponsor of clinical trials while ATMA will deliver Expertise in clinical research through his medical advisory team.
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Read full story here https://www.benzinga.com/markets/cannabis/22/09/28970024/two-psychedelics-companies-are-aiming-to-study-the-effects-of-natural-psilocybin-and-mdma-combin