Canadian company gets Health Canada approval for psychedelic-assisted therapy study

NUMIF, a psychedelic-assisted therapy provider, received Health Canada approval for its experiential training study, which will assess 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 Numinus CEO and founder Payton Nyquvest, this data will be instrumental in providing health regulators with the information they need to make decisions about access to psilocybin-assisted therapies using psilocybe mushrooms, as a first clinical trial to study the safety and clinical efficacy of whole psilocybe mushrooms in their naturalistic form.

CSO Paul Thielking said that the company recognizes that one of the challenges of the psychedelic-therapy industry is having enough properly trained therapy administrators, which is why the study design is based on that.

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

Three sessions are included in the protocol, including preparation, dosing and integration, followed by an observation period, interviews and questionnaires.

Each volunteer will be able to participate 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 psilocybin supplier list that has already been submitted to the Canadian health authorities to be included in the psilocybin supplier list for the federal Special Access Program.