Numinus Wellness Inc. (TSX: NUMI | OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced that its research division has submitted a clinical trial application to Health Canada to begin a new experiential training study that will enable practitioners training to provide Psilocybin-Assisted Therapy (PAT) the ability to experience and observe psilocybin sessions to further their understanding and PAT education. Additionally, the clinical trial will use Numinus Bioscience’s EnfiniTea, a whole mushroom Psilocybe tea product, for trial dosing. This is one of the first clinical trials globally that will be conducted with whole Psilocybe mushrooms, to assess their safety.
“We’re proud to offer one of the first training programs with the option to participate in an experiential clinical trial for practitioners looking to expand their psychedelic-assisted therapy education. As these important therapies continue to develop and gain support, we foresee the psychedelic sector may experience a shortage in sufficiently trained PAT therapists. We’re honored to offer this unique experiential clinical trial opportunity alongside our well-regarded psychedelic training programs to expand the number of highly qualified practitioners and drive further access to those in need of these mental health treatments.”
Paul Thielking, Chief Science Officer, Numinus
The clinical trial, formally titled A Phase 1, Open-Label, Single-Arm Study to Evaluate Psilocybin Experiential Training in Healthy Volunteers and Expand Knowledge and Qualifications of Therapists Planning to Conduct Psilocybin-Assisted Therapy (NUMT2), will initially be conducted at Numinus’ clinic in Vancouver. Numinus expects the clinical trial may be expanded to include additional Numinus clinic locations in the future.
“We expect the EnfiniTea Psilocybe tea we’ve developed will support expanded access to important psychedelic-assisted therapies, as it’s uniquely shelf stable, consistently dosed and economical to produce,” said Sharan Sidhu, VP, Scientific Research, Innovation & Laboratory Operations, Numinus Bioscience. “We’re pleased to be able to utilize this product in the NUMT2 clinical trial, as research on whole Psilocybe mushroom in a clinical setting is limited in Canada and the results of this trial may support regulators in expanding access to whole-mushroom psychedelic-assisted therapies through Canada’s Special Access Programme and other expanded access frameworks.”
The NUMT2 clinical trial protocol will enable each practitioner volunteering for the trial to participate in both experiential and observational roles, receiving psilocybin-assisted therapy, as well as observing another participant receiving the therapy under the supervision and guidance of an experienced and trained therapy provider. Numinus intends to initially draw on volunteers for the clinical trial through those who have expressed interest through the Company’s practitioner training program. The clinical trial will also be open to other practitioners interested in volunteering to expand their knowledge of PAT therapy practices.
About Numinus
Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.