Numinus Partners With MAPS To Conduct Phase 1 MDMA Assisted Therapy Investigational Study

In a prelude to what is hoped will be regulatory approval of MDMA-assisted therapy in the U.S. and Canada, Numinus Wellness Inc. NUMIF has taken steps to get out in front of the curve. Today, the company has announced a partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS) that aims to provide practitioners with unique experiential opportunities as part of a clinical study focused on MDMA-assisted therapy.

Under the proposed initiative, Numinus plans to offer exclusive experiential opportunities for practitioners involved in the clinical study, pending the approval of their Clinical Trial Application (CTA) by Health Canada. If the CTA is accepted, Numinus will become the sole provider of MDMA-assisted therapy experiential opportunities. The CTA has been submitted by Numinus through its wholly-owned subsidiary, Numinus Wellness Research Inc.

The primary objective of the clinical trial is to enable interested practitioners to gain first-hand experience and observation of MDMA sessions, thereby deepening their understanding of psychedelic-assisted therapy. The trial will be conducted using clinical MDMA produced by Optimi, a Canadian-based drug manufacturer and formulator licensed by Health Canada for the production and supply of psychedelic substances for clinical trials.

If the trial protocol is approved, Numinus would be best positioned to provide  training with our experiential opportunities, Practitioners who complete our MDMA-assisted therapy education program, or have already completed previous MDMA-assisted therapy programs and are qualified to enroll in our Practical Applications course, would be able to apply to participate in the experiential clinical trial – enabling them to observe, deliver, and receive the therapeutic protocol as part of their training experience.

Payton Nyquvest, Founder and CEO of Numinus Wellness

Nyquvest further emphasized the potential for collaboration between Numinus and MAPS, saying, “With a shared vision and commitment to driving greater understanding and accessibility to MDMA-assisted therapies, we believe this new offering is a gateway to greater collaboration with MAPS in the months ahead.”

The clinical trial, officially titled “A Phase 1, Open-Label, Single-Arm Study to Evaluate MDMA Experiential Training in Healthy Volunteers and Expand Knowledge and Qualifications of Therapists Planning to Conduct MDMA-Assisted Therapy (NUMT1),” is slated to commence at Numinus clinics in Vancouver, pending approval. The company plans to expand the trial to include additional clinic locations in the future.

Rick Doblin, the Founder and President of MAPS, expressed his excitement about the partnership, stating, “Our 37-year journey to medicalize the therapeutic use of psychedelics has never been closer to a reality, and we’re thrilled to have Numinus as a partner in this work. Experiential training is an important element of a practitioner’s training in many therapeutic modalities, and through this carefully controlled clinical trial, Numinus is supporting our shared goal of providing training to practitioners who may one day deliver psychedelic-assisted therapy to individuals who need it.”

If approved, the NUMT1 clinical trial protocol will allow participants to assume both experiential and observational roles.

Each participant will receive investigational MDMA-assisted therapy while also observing another participant undergoing therapy under the supervision of an experienced and trained therapy provider. Numinus intends to recruit volunteers for the clinical trial from practitioners who have expressed interest through their practitioner training program, as well as those who have previously completed the MAPS protocol training and meet the qualifications for the MDMA-Practical Applications course.