Canadian wellness company Psirenity has announced that it has received approval to conduct the first clinical trial protocol with psilocybin in Jamaica.

Psilocybin is a hallucinogenic substance people ingest from certain types of mushrooms that grow in regions of Europe, South America, Mexico, and the United States. The mushrooms containing psilocybin are known as magic mushrooms.

Psirenity, which is a wholly owned subsidiary of New Leaf Canada Inc, which is emerging as a global leader in science-backed brain health and wellness, will be partnering with the University of the West Indies (UWI) in executing the clinical trials. The protocol to guide the clinical trial was approved by UWI’s Ethics Committee.

The clinical trial will begin within the next 90 days at UWI’s Caribbean Institute for Health Research with 32 patients. The process will be led by Professor Roger Gibson, principal investigator.

Trials aimed at assessing two unique psilocybin micro-dose products

The Phase I open-label multiple micro-dose study with purified psilocybin will use standard and controlled release oral tablets. The trial is aimed at assessing the safety, tolerability and pharmacokinetics of two unique psilocybin micro-dose products developed by the Psirenity team in the management of mild to moderate depression.

Psirenity as a company focuses on providing holistic treatments that help solve today’s mental health pandemic. This is being done by expanding the company’s own understanding and the world’s acceptance of advanced psychedelic-enhanced mental health solutions, while accelerating patient intake and commercialisation of its products.

Commenting on the clinical trial in Jamaica, Psirenity CEO Chris McCullough reports that, “the clinical trial is not only a historical first for Jamaica, it showcases the advanced state of Psirenity and its commitment to science-backed methods for improving wellness. We are confident our Phase 1 trial will highlight the medical benefits and positive impacts of using our innovative psilocybin delivery systems to manage depression in adults”. 

He explains that, “this clinical study is the first and only one of its kind approved in the Caribbean, which will surely pave the way for further studies aimed at proving the medical benefits of psilocybin in brain health and wellness. Through our strong partnerships with key agencies in Jamaica, such as, the University of the West Indies, Scientific Research Council, Research and Product Development Solutions, Jamaica and LONACAS Consulting, we are positioned to make tremendous strides in our psychedelic mushroom clinical, wellness and cultivation programs in Jamaica and the wider Caribbean.”

Worldwide, more than 300 million people suffer mental health issues, creating a potential market worth $233 billion.

New Leaf Canada was founded in 2010 by former NHL enforcer Ryan VandenBusssche to explore alternative treatment for physical and mental health wellness. VandenBusssche is a passionate spokesperson and advocate for bringing alternative health and wellness solutions to both athletes and millions of pain sufferers worldwide from his federally licensed Innovation Centre.