Optimi Health has submitted an application to carry out a Phase I clinical trial investigating the safety of the combinatory use of psilocybin and MDMA in healthy therapists.
The study will document the safety of Optimi’s natural psilocybin standardised extract and proprietary MDMA drug candidate in healthy therapists.
The investigator-initiated double-blind placebo-controlled study is being conducted through ATMA Journey Centers in Calgary, Alberta, and will be the first-of-its-kind to directly compare the acute effects of these substances within the same clinical study.
Optimi hopes to confirm the suitability for use of these substances, combined and separately, in experiential training by psychedelic therapy practitioners.
Optimi CEO, Bill Ciprick, commented: “With an estimated 25,000 to 100,000 therapists needed to support the millions of people suffering with post-traumatic stress disorders, 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.
“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.”
During the trial, participants will receive 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, including blood pressure, temperature, heart rate, ECG readings, and will assess both safety and additional markers, such as the mystical experience questionnaire in the healthy therapist subjects that have consumed Optimi’s proprietary MDMA formulation and natural GMP psilocybin.
It has also stated the company is exploring the potential inclusion of novel, non-invasive, whole-body electrophysiological technology that would provide real-time functional analyses of 24 organs and glands on each participant.
Ciprick added: “This is about helping people heal. Optimi Health receives emails from patients and physicians on an almost daily basis, searching for our help in obtaining some level of mental health support and asking when these modalities might be available to them.
“They are entrusting us to deliver because they still have hope, and that is why we have set an ambitious course of action in 2023 that will help therapists complete their training in time to bring them the support they need.
“This trial offers a tangible step forward in that essential process, for which the endpoint is providing relief for countless sufferers.”
Optimi Health products are still being investigated through a clinically validated development programme for the purpose of applying for market authorisation, and the safety and efficacy of its products are still being formally established.
