Earlier in November, Numinus Wellness Inc., announced that it is planning a compassionate access clinical trial of psilocybin-assisted psychotherapy for substance use disorders. Numinus, originally created as a cannabis technology company, has also focused on the research, development, and delivery of safe, evidence-based, accessible psychedelic-assisted psychotherapies.
Psilocybin is a naturally occurring psychedelic prodrug compound found in over 200 species of fungus (also known as “magic mushrooms”). In recent years, there has been increasing research in the use of psychedelics, such as psilocybin, LSD, MDMA and ketamine to treat addiction and mental health disorders, including post-traumatic stress disorder (PTSD), depression and anxiety.
The study being carried out will enable the company to examine and refine various protocols for the use of psilocybin-assisted psychotherapy for participants with various substance use disorders. Moreover, the trial will be conducted in collaboration with Syreon Corporation, a global contract research organization that specializes in conducting clinical trials across a broad range of chronic and complex diseases. The clinical trial will include 30 participants who will take part in a motivational enhancement psychedelic psychotherapy intervention with psilocybin. The overall aim of this open-label clinical trial is to determine the optimal methods of delivery of psilocybin-assisted psychotherapy for participants with tobacco, stimulant, alcohol, and/or opioid disorders.
According to Health Canada’s Special Access Programme, such compassionate access, single-arm open-label clinical trials can be incorporated into drug development planning to “meet the needs of patients who are not eligible for enrollment in other pivotal trials.” Which is good news as it is one of Health Canada’s preferred means for patients to gain access to drugs that are not yet available on the market.
“Research has already demonstrated great promise for psilocybin-assisted psychotherapy as a treatment for certain substance use disorders,” said Dr. Evan Wood, Chief Medical Officer of Numinus. “But, psilocybin is still illegal in Canada. This compassionate access trial will begin to address the hurdle of public accessibility, while allowing us to evaluate service delivery models and study the impacts of psilocybin-assisted psychotherapy as an adjunct to standard of care treatments for substance use disorders.”
This compassionate access trial is the first in a series of planned projects and collaborations launched to expand access to MDMA for treatment of PTSD and psilocybin for treatment of substance use disorders. Specifically, such trials will allow Numinus to refine clinical protocols and strategies for when these treatments gain approval for widespread use by regulatory bodies.
“The tides are turning for the regulated use of psilocybin, as witnessed earlier this month in the United States. A yes vote for Measure 109 in Oregon permits licensed service providers to provide psilocybin-assisted psychotherapy, and Health Canada has an ongoing provision of exemptions for psilocybin for medical use,” said Numinus Founder, CEO, and Chair, Payton Nyqvest. “By increasing access through a compassionate access trial, we hope to help lead the way to regulation in Canada through our implementation science approach which will provide critical outcome and safety data to health regulators.”