Arizona is on the verge of a groundbreaking clinical trial that could shift the landscape of psychedelic medicine. The state is preparing to fund the nation’s first-ever study on the effects of magic mushrooms—also known as psilocybin mushrooms—on selected patients. This trial, spearheaded by the Scottsdale Research Institute (SRI), promises to explore the potential benefits of psilocybin mushrooms in treating conditions like post-traumatic stress disorder, chronic pain, and life-threatening illnesses.

The U.S. Food and Drug Administration (FDA) recently lifted its hold on SRI’s proposed clinical trial, a key step in making this ambitious study a reality. The Psilocybin Research Advisory Council, part of the Arizona Department of Health Services, awarded roughly $2.5 million of a $5 million grant that Arizona Legislature had previously dedicated to natural psilocybin research.

What Makes This Trial So Special?

While many trials studying psychedelics have focused on isolated psilocybin molecules, SRI’s study will be unique in its approach. The researchers will be working with the entire mushroom rather than extracting just the active compound, psilocybin. SRI believes that this holistic approach may offer more potent therapeutic benefits by harnessing the combined effect of the full range of compounds naturally found in mushrooms.

The decision to use whole magic psilocybin mushrooms rather than isolated compounds is a key differentiator for this trial. The complex nature of the mushrooms has made their inclusion in scientific trials more challenging. Standardizing the dosage and ensuring the potency, purity, and stability of the mushrooms for research purposes are key factors. To account for these variables, SRI has grown its own mushrooms and has undergone extensive testing to ensure consistency in their anticipated trials.

Critically, the research and data from these trials is much more accurate when SRI can ensure that each participant receives the same, reliable dosage.

The Bigger Picture: Research vs. Legalization

While the debate over the therapeutic use of psilocybin has gained significant momentum throughout the country, Arizona’s approach is uniquely focused on science first. Last year, Governor Katie Hobbs vetoed a bill that would have legalized psilocybin mushrooms for therapeutic use, citing a need for more research to back up their potential benefits. SRI’s clinical trial is the answer to Governor Hobbs’ call for more data. With this research, Arizona may join states, such as Oregon and Washington, which have created psilocybin treatment centers for the regulated use of mushrooms. More data will allow Arizona leaders the ability to make informed decisions about whether to expand access to psilocybin mushrooms for therapeutic use, ensuring that any future regulatory measures are based on scientific evidence.

The Path Forward

While the approval from the FDA is a significant victory, the trial is not yet underway. SRI must still submit a final clinical proposal to the FDA, get approval from the Institutional Review Board, an independent ethics board, and secure a final green light from the DEA before the study can officially commence. But if successful, the results of this trial could change how the medical community views psychedelic therapies.

The promise of psychedelic medicine is still in its infancy, but Arizona’s first clinical trial of whole magic mushrooms may very well be the tipping point that accelerates the awareness, acceptance, and application of these substances for medical use.

Bianchi & Brandt will continue to monitor legal developments in the growing area of psychedelics sciences. If you have any questions, please feel free to contact us.