Alira Health Collaborates with Scottsdale Research Institute for State-Funded Psilocybin Trials

Alira Health, a prominent global advisory and clinical research firm based in Framingham, Massachusetts, has announced a partnership with the Scottsdale Research Institute (SRI). This collaboration aims to advance clinical research on psilocybin in Arizona, providing comprehensive regulatory and clinical support. The joint effort will focus on regulatory strategy, submissions, monitoring, clinical trial design, and operations.

In 2023, a coalition of military veterans, firefighters, and terminally ill Arizonans successfully advocated for a $5 million allocation to support natural psilocybin research. The funding, administered by the Psilocybin Research Advisory Council at the Arizona Department of Health Services (ADHS), will facilitate this research initiative. ADHS conducted a competitive procurement process, selecting SRI to lead the first controlled study of psilocybin mushrooms in humans. This study, classified as an FDA Phase 1/2 trial, will target patients with life-threatening illnesses.

Pending approvals from the FDA and Arizona State University's Institutional Review Board (IRB), Arizona could become the first state in the U.S. to conduct an IND-enabled randomized controlled clinical trial using whole mushrooms to deliver psilocybin. The SRI-led trial aims to expand the scientific understanding of psilocybin's therapeutic potential for various conditions, including chronic pain, PTSD, long COVID, OCD, depression, autoimmune disorders, and terminal illnesses.

The state funding will support SRI's efforts to gain clinical approval and ensure robust regulatory oversight, trial implementation, and clinical operations. The Psilocybin Research Advisory Council, responsible for overseeing these activities, will also provide counsel to the governor and legislature on the medical use of psilocybin.

Gabriele Brambilla, CEO of Alira Health, expressed enthusiasm about the initiative, highlighting its potential to revolutionize mental health treatment. Alira Health's team of experts will collaborate closely with SRI to navigate the complexities of drug development, prioritizing safety and efficacy in these groundbreaking trials.

Dr. Sue Sisley, President of SRI, emphasized Arizona's potential to become a global leader in psilocybin research. She noted that whole psilocybin mushrooms might offer enhanced therapeutic benefits compared to synthetic alternatives currently under study.

Alira Health is dedicated to humanizing healthcare and life sciences through innovative technologies and expert guidance. The firm supports its clients across the entire lifecycle of their solutions, from development to medical care.

Scottsdale Research Institute focuses on advancing safe, legal access to Schedule 1 medicines under the federal Right to Try law. SRI conducts FDA-authorized human studies to evaluate the medical safety and efficacy of inhaled cannabis flower, oral psilocybin mushrooms, and other psychedelics for treating pain, PTSD, and opioid use disorders.