Numinus Wellness has received clearance from Health Canada for its experiential training study to test the safety and clinical efficacy of whole Psilocybe cubensis tea for therapeutic use.
The Canada-based mental healthcare company said that the study will help practitioners to better understand psychedelic-assisted therapy through experiential training.
Numinus Wellness said that the clinical trial will be initially held at its Vancouver clinic for which volunteer selection will take place in the coming weeks.
Practitioners who have completed or are enrolled in the company’s training programme or other approved ones who are trained to deliver psilocybin-assisted treatment will be selected as study participants.
The study’s preliminary findings are anticipated to be published in the latter half of this year.
Numinus Wellness CEO and founder Payton Nyquvest said: “We’re thrilled that Health Canada has provided us with their prompt approval and support in starting this important clinical trial.
“As the first clinical trial to study the safety and clinical efficacy of whole psilocybe mushrooms in their naturalistic form, we expect this data will be instrumental in providing health regulators with the information they need in order to make decisions around expanding access to psilocybin-assisted therapies using Psilocybe mushrooms.”
According to the mental healthcare firm, the clinical trial protocol for each participant will include a preparation session, a dosage session, and an integration session.
These sessions will be followed by an observation period, participant interviews, and questionnaires.
Each experiential training study volunteer will participate throughout the clinical trial as both a study participant receiving the protocol and an observer for another participant’s sessions.
The clinical trial will use EnfiniTea, the company’s whole mushroom psilocybe tea product carrying 25mg of psilocybin for trial dosing.
EnfiniTea is said to be produced using Numinus Wellness’ own validated strain of psilocybe cubensis BP-Star. The product is shelf stable, consistently dosed, and has low production costs, claimed the company.
Additionally, the product has been submitted to Health Canada in order to be listed on the supplier list for psilocybins under the federal Special Access Program.
