Canadian trials started for Psilocybin-Assisted Psychotherapy for Substance Use Disorders

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.”

10 responses to “Canadian trials started for Psilocybin-Assisted Psychotherapy for Substance Use Disorders

  1. Who can I speak to about having my sister join this trial? I am panicking that she is at a place where she will do harm to herself. I’ve pushed her to get her nutrition in order (magnesium, Vitamin b complex, Vitamin d, etc) instead of overuse of pharmaceuticals that haven’t been working. I’ve seen some reports of people who have turned the corner after using psilocybin and I’m hoping this could help her too.

    1. You would have to contact the company that is running the trial, as named in the article. They should be able to give you information about the trials. You can also always contact your province’s community and social services to access other support services to help your sister (in Ontario https://211ontario.ca).

  2. This might be the route for me to investigate. I need to feel alive instead of being on medication which take away my natural self. Anxiety, panic attack and PTSD have robbed me from living.

    1. I’m so sorry to hear of your troubles. Hopefully this research will help you, and others such as yourself, have more options to improve your quality of life.

  3. Hello. I am a 55 yr old male who suffered a serious brain injury in 1987. I’m very interested in this subject to help me reach the next level in brain injury recovery. Brain injuries mirror depression, except anti depressants don’t work for people like me.

  4. My grandson suffers from severe anxiety as well as depression. The meds and talk therapy he has been prescribed aren’t working and he’s getting worse. We are terrified he will harm himself if he doesn’t get proper help with this.

  5. Are you aware of any clinical trials studying psilocybin assisted therapy for someone diagnosed with Bipolar Type 2 or Borderline Personality Traits?

    1. Hello Donna, I’m not really sure about the current trials, or future ones, taking place, your best bet is to contact the company involved to find out about their scheduled trials. Good luck!

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