Numinus Wellness Inc. (TSX:NUMI, OTC:LKYSF) has 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.
The company said the clinical trial will use Numinus Bioscience's EnfiniTea, a whole mushroom Psilocybe tea product, for trial dosing, making it 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," Numinus chief science officer Paul Thielking said in a statement.
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"As these important therapies continue to develop and gain support, we foresee the psychedelic sector may experience a shortage in sufficiently trained PAT therapists,” Thielking added. “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.”
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 the company’s Vancouver clinic. It may be expanded to include additional Numinus clinic locations in the future, it added.
"We expect the EnfiniTeaPsilocybe 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," Numinus Bioscience ripe president for scientific research, innovation & laboratory operations Sharan Sidhu said.
"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."
Numinus said 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.
The company said it intends to initially draw on volunteers for the clinical trial through those who have expressed interest through its practitioner training program. The clinical trial will also be open to other practitioners interested in volunteering to expand their knowledge of PAT therapy practices, it added.
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.
Contact the author at stephen.gunnion@proactiveinvestors.com