Scottsdale Research Institute gears-up for 1st ever Natural Psilocybin Mushroom Human Trial Funded by State of Arizona

By the Scottsdale Research Institute

Scottsdale Research Institute (SRI) announced today it will lead the first government-funded global study on whole natural psilocybin mushrooms, positioning Arizona as a leader in psilocybin research. This groundbreaking initiative was driven by a diverse coalition of military veterans, firefighters, and Arizonans with terminal illnesses, who successfully advocated for the legislature to approve $5 million in 2023 for natural psilocybin research. The Arizona Department of Health Services facilitated a rigorous procurement
process, resulting in SRI receiving the funding to conduct the first human- controlled study of real-world psilocybin mushrooms, an FDA Phase 1/2 trial for patients with life-threatening illnesses. The increasing mainstream attention and viral interest in psilocybin mushrooms underscore the significance of this research.

Journalists are invited to an exclusive preview of the clinical trial space at the SRI laboratory on
Tuesday, May 28, from 11 AM to 12 noon, with additional tours available by appointment. This is a rare opportunity to witness the entire psilocybin mushroom growing process in a DEA- approved facility, observe the stringent scientific protocols in place, and engage directly with military veterans, firefighters, and terminally ill Arizonans who have experienced the benefits of psilocybin mushrooms. For the first time ever, the DEA-approved safe will be opened to reveal a real psilocybin mushroom, providing an unparalleled glimpse into this groundbreaking research.

The funding partnership with State of Arizona will enable support in government regulatory submissions, regulatory monitoring, clinical trial design and clinical operations. Once approved by the FDA and ASU IRB committee, Arizona will be the first state in the United States to conduct an Investigational New Drug (IND)-enabled randomized controlled clinical trial utilizing whole real-world mushrooms to administer psilocybin for the treatment of patients with various mental health conditions, including chronic pain, post-traumatic stress disorder (PTSD), long COVID, obsessive-compulsive disorder (OCD), depression, substance abuse, autoimmune disorders, and terminal illnesses. Regulatory activities currently underway are funded by a grant program established by the newly created Psilocybin Research Advisory Council. The council will also advise the governor and the legislature on the use of psilocybin in medical treatment.

“Arizona is at the forefront of this clinical research, leading the charge in exploring innovative treatments for mental health and chronic pain,” President, SRI Foundation Nicole Nichols commented. “Our state’s commitment to scientific inquiry and patient well-being positions us as a national leader in this transformative field. Board chairman, John Lenstrohm shared: “By embracing evidence-based approaches and fostering a collaborative environment for research, we are not only advancing mental health treatments but also paving the way for a healthier, more resilient Arizona. Together, we are breaking new ground in the fight against mental illness, ensuring that those in need have access to the most cutting-edge and effective therapies available.”

“The state of Arizona is on the cusp of becoming a world leader in conducting first ever studies of natural psilocybin mushrooms in FDA controlled trials,” said Dr. Sue Sisley, MD President of SRI. “Whole psilocybin mushrooms, with all of the molecules working together, could offer superior healing potential than one synthetic molecule, which is the only study drug currently being examined.”. “We are pleased to be part of a groundbreaking initiative that has the potential to revolutionize mental health treatment,” said Gabriele Brambilla, CEO of Alira Health. “Our team of regulatory and clinical experts will work closely with SRI to navigate the complex landscape of drug development and ensure that these clinical trials are conducted with the highest standards of safety and efficacy.”