Alira Health tapped to assist in Arizona psilocybin studies

Psychedelic clinical research firm Alira Health will collaborate with the Scottsdale Research Institute (SRI) to provide regulatory and clinical support to bring clinical research of psilocybin to the state of Arizona.

Alira said that the partnership would provide strategic guidance and support in regulatory strategy, regulatory submissions, regulatory monitoring, clinical trial design, and clinical operations.

“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, 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.”

Interested parties in Arizona have been laying the groundwork for psilocybin research. In 2023, a diverse coalition of military veterans, firefighters, and Arizonans with terminal illnesses pushed for the legislature to approve $5 million for natural psilocybin research. According to the statement, this research will be funded through a grant program administered by the Psilocybin Research Advisory Council at the Arizona Department of Health Services.

SRI was awarded the funding to conduct the first controlled study of psilocybin mushrooms in humans, a U.S. Food and Drug Administration Phase 1/2 trial in patients with life-threatening illnesses.

Arizona legalization

Last week, Marijuana Moment reported that the Arizona House of Representatives approved a Senate-passed bill to legalize psilocybin service centers where people could receive the psychedelic in a medically supervised setting. The next stop is Gov. Katie Hobbs’s desk for signature.

The legislation would also authorize the ADHS to license psilocybin-assisted therapy centers in the state, where trained facilitators could administer the drug.

In addition, the legislation creates the Arizona Psilocybin Advisory Board, which would establish training criteria for psilocybin service center staff, make recommendations on executing the law, and study the science and policy developments related to psychedelics.

Arizona wants to go first

If approved to proceed with testing in human subjects by both the FDA and Arizona State University’s Institutional Review Board committee, Arizona would be the first state in the United States to host an Investigational New Drug-enabled randomized controlled clinical trial utilizing whole mushrooms to administer psilocybin.

SRI said in a statement that it hopes this trial will contribute to the base of scientific evidence regarding the potential use and efficacy of psilocybin treatment for patients with various health conditions, including chronic pain, post-traumatic stress disorder (PTSD), long COVID, obsessive-compulsive disorder (OCD), depression autoimmune disorders, and terminal illnesses.

“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.”