If approved, the trial would allow Numinus to study MDMA-assisted psychotherapy with groups and better understand the optimum number of therapists required to deliver the programs safely.
Numinus Wellness Inc. said it has submitted a clinical-trial application to Health Canada to examine the feasibility of a group model in MDMA-assisted psychotherapy enrolling trainee practitioners as participants.
If approved, the trial would allow Numinus to study MDMA-assisted psychotherapy with groups and better understand the optimum number of therapists required to deliver the programs safely, according to Numinus.
Approval also could provide eligible trainees with the opportunity to build core competencies and legally experience MDMA, the company noted.
“As research into MDMA’s efficacy in addressing serious mental conditions is increasing, it is particularly important that practitioners advance their knowledge of optimum delivery in a clinical setting,” said Payton Nyquvest, founder and CEO of Vancouver-based Numinus. “Our goal in designing this study is to explore the feasibility of a group model and take steps to help establish best practices in group-based therapy for MDMA and contribute to the body of evidence of its safety.”
The clinical trial is formally titled “Phase 1 Exploration of Feasibility and Optimal Therapist Numbers in Group Model MDMA-Assisted Psychotherapy: A Study on Safety, Delivery, and Practitioner Training.” If approved, it would be the first of its kind.
“Considering the large potential patient population that could be seeking care should MDMA-assisted therapy receive approval, it will be essential for clinics and practitioners to gain the knowledge and experience to deliver this groundbreaking treatment for PTSD,” said Rick Doblin, who is serving as an unpaid volunteer Numinus strategic advisor. “This study has the potential to significantly enhance patient outcomes by providing a means for practitioners to gain valuable insights.”
Details on participating in the clinical trial will be posted on the Numinus website.