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Numinus Submits MDMA Group Therapy Clinical Trial Application

The TDR Three Takeaways for Numinus

  1. Numinus Wellness Inc. has applied for a clinical trial to explore MDMA-assisted psychotherapy in a group setting, aiming to establish safe delivery practices. 
  2. If approved, the trial will enhance practitioner competencies in MDMA therapy.
  3. Numinus’s initiative could impact mental health care, offering insights into optimal therapist-patient ratios. 

Numinus Wellness (TSX: NUMI, OTCQX: NUMIF), a Vancouver, Canada mental health care and psychedelic-assisted therapies company, yesterday announced its submission of a Clinical Trial Application to Health Canada. This significant step aims to investigate the feasibility of MDMA-assisted psychotherapy within a group model, specifically enrolling trainee practitioners as participants. If the trial receives approval, it will mark a pioneering effort to understand the most effective ways to deliver these treatments safely.

The focus of the proposed trial is twofold: to determine the optimal number of therapists required for safe delivery of MDMA-assisted psychotherapy and to provide trainees with the chance to develop core competencies in this area. The initiative reflects Numinus’s commitment to advancing the field of mental health care by exploring innovative therapeutic models.

MDMA, known for its potential in treating serious mental conditions such as PTSD, is at the forefront of psychiatric research. Numinus’s clinical trial is designed not only to expand our understanding of MDMA’s therapeutic efficacy but also to establish best practices for group-based therapy. This approach aligns with the growing recognition of the need for scalable, effective treatment options in mental health care.

The involvement of Rick Doblin, PhD., as an unpaid volunteer and strategic advisor to Numinus, underscores the trial’s importance. Doblin highlighted the potential for this study to improve patient outcomes significantly by equipping practitioners with valuable insights into MDMA-assisted therapy’s practical application.

Numinus is focused  on transforming mental health care by integrating evidence-based psychedelic therapies into mainstream clinical practice. The company’s holistic model encompasses psychedelic research, clinical care, and practitioner training. Through initiatives like this clinical trial, Numinus aims to foster a healthcare paradigm focused on healing rather than merely managing symptoms, addressing critical issues such as depression, anxiety, trauma, pain, and substance use. The trial represents a vital step towards integrating psychedelic-assisted therapies into conventional mental health treatments, potentially revolutionizing the way we approach mental health care.

The trial’s approval would be significant, signifying a move towards more inclusive and comprehensive mental health care strategies. It highlights the importance of developing therapies that are not only effective but also cost accessible to a broad spectrum of patients and practitioners alike. Want to keep up to date with all of TDR’s research and news, subscribe to our daily Baked In newsletter.   


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