Psychedelic-assisted therapy provider, Numinus Wellness Inc. (OTCQX:NUMIF) received Health Canada's approval for its experiential training study, which will assess both the safety and clinical efficacy of whole magic mushrooms tea as well as enable practitioners to expand their understanding of psychedelic-assisted therapy by consuming the substance themselves.

"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," said Numinus CEO and founder Payton Nyquvest.

See also: Numinus CEO Payton Nyquvest Believes MDMA "Most Likely" To Be Approved At The End Of 2023

CSO Paul Thielking added that the company recognizes that one of the psychedelic-therapy industry's challenges is having enough properly trained therapy administrators, which explains the study's design.

The open-label, single-arm Phase 1 trial will initially be conducted at Numinus' Vancouver clinic and will start selecting healthy volunteers in the upcoming weeks. On the practitioners' side, selection will focus on individuals who have trained or are presently training to provide psilocybin-assisted therapy through the company's or other approved training programs.

The protocol includes three sessions including preparation, dosing and integration to be followed by an observation period, interviews and questionnaires.

Each volunteer will participate both as a study participant receiving the therapy and as an observer for another participant's sessions (overseen by an experienced practitioner).

The dose will consist of Numinus' EnfiniTea, a whole-mushroom psilocybe tea product delivering 25 mg of psilocybin which has already been submitted to the Canadian health authorities to be included on the psilocybin supplier list for the federal Special Access Program.

Photo: Benzinga edit with photo by Krakenimages.com and Cannabis_Pic on Shutterstock.