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Licensed psychedelic drugs producer Optimi Health Corp. OPTHF submitted a Health Canada clinical trial application (CTA) for a Phase 1 study that will assess the safety of combining its natural psilocybin standardized extract with its proprietary MDMA drug candidate in healthy therapists.
See also: MDMA News: Optimi’s New Drug Now Available, Revive Advances Transdermal Patch Evaluations
The investigator-initiated, double-blind, placebo-controlled study to be conducted through ATMA Journey Centers in Calgary, Alberta will combine the substances and compare their acute effects separately.
CEO Bill Ciprick stated: “With an estimated 25,000 to 100,000 therapists needed to support the millions of people suffering with PTSDs, Optimi feels strongly that clinical research undertaken at this stage by GMP cultivators and formulators in partnership with mental health training services such as ATMA should be geared toward meeting this immediate need.”
See also: Learn How To Safely Facilitate Psychedelic Therapy With These New Training Programs
Ciprick said “therapists provided experiential training with both substances will in turn be able to provide greater value and higher standards of care to patients undergoing these treatments.”
The trial is designed as a five-arm study with 25 participants who will undergo a supervised experimental session with either 25mg of natural psilocybin and a placebo, 125mg of MDMA and a placebo, or 25mg of natural psilocybin in combination with MDMA (50mg, 80mg, or 125mg).
Optimi will collect data such as blood pressure, temperature, heart rate and ECG readings, as well as assess safety and additional markers such as the mystical experience questionnaire.
The company is considering including a novel, non-invasive, whole-body electrophysiological technology that would provide real-time functional analyses of participants’ organisms.
Photo: Benzinga edit with photo by Bacsica, aiyoshi597, Gisele Yashar and Gorodenkoff on Shutterstock.
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Image and article originally from www.benzinga.com. Read the original article here.