Health Canada receives applications concerning clinical trials on a regular basis. This time, the licensed producer of natural EU-GMP psilocybin and MDMA Optimi Health Corp. OPTHF together with ATMA Journey Centers say they intend to submit a Phase I clinical trial application (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 -i.e. a mystical experience questionnaire- in healthy subjects after ingestion of the company’s proprietary formulation of natural psilocybin and MDMA.
Optimi’s CEO Bill Ciprick expressed his eagerness to commence this trial: “For the thousands of trained professionals waiting to experience natural, EU-GMP psilocybin and MDMA, we share their enthusiasm and believe we have an ethical responsibility to supply them with a life-changing product that is receiving considerable attention from regulatory bodies across the world.”
On behalf of ATMA, CEO David Harder recognized the importance of the CTA context and asserted the company’s commitment to the building of a therapist-centered and therapist-driven support and training approach.
Harder believes that clinical evidence through experiential learning about the effect of these molecules “is critical in providing a solid training program for therapists to prepare for the need that is already at our doorstep.”
The current partnership is meant to expand the relationship between the two companies, which began with a psilocybin supply deal earlier in 2022. In it, Optimi will constitute the official clinical trial sponsor while ATMA will deliver clinical research expertise through its medical advisory team.
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