Wake Receives First-Ever Approval for Psilocybin Microdose Study for Anxiety and Depression

Bioscience company Wake Network Inc., will hold the world’s first microdosing clinical trial using naturally-derived psilocybin mushrooms after receiving clearance from Jamaica’s Ministry of Health. The company will be partnering with the University of West Indies to gather quality data on the effects of psilocybin microdosing on anxiety and depression.

No previous studies have documented the effects of psilocybin microdosing in structured clinical trials. Nor have any used naturally-sourced psilocybin, only synthetic versions of the medicine. Wake’s study will use federally-approved psilocybin mushroom material produced at the company’s manufacturing facility in Jamaica. The research will provide regulators with greater data on psilocybin microdosing efficacy. 

“Microdosing psilocybin is increasingly becoming a popular practice worldwide,” said Dr Olga Chernoloz, Chief Medical Officer of Wake Network. “Our goal is to bring these medicines to a larger group of users in a safe and compliant manner.”

The phase 2b psilocybin microdosing clinical trial will be registered at the clinicaltrials.gov database and pre-registered at Open Science. 

Wake is also developing psilocybin for other therapeutic uses, including post-traumatic stress disorder (PTSD) and traumatic brain injuries (TBIs), with a goal of obtaining institutional review board approval for future microdosing clinical trials.

In that vein, the company is partnering with the University of West Indies and the Lieber Institute for Brain Development Maltz Research Laboratories, to develop the first genetics-based clinical trial to study the effects of psilocybin on TBIs. The Wake Genomics Project will be a laboratory screening process integrated with a one-of-a-kind cloud-based AI-Reference library of genetics. As part of this effort, Wake is building an Athletic Council to focus on research, recruitment, and awareness psilocybin therapy for TBI.