The trial builds on a growing body of innovative research on psychedelic medications for substance use disorders supported by the National Health and Medical Research Council, Medical Research Future Fund and pharmaceutical industry partners.

The University plans to conduct a randomised placebo-controlled Phase IIB trial of a novel synthetic formulation of the naturally occurring psychedelic, psilocybin, developed by Sydney-based company Woke Pharmaceuticals. The trial is designed to recruit participants with alcohol use disorder who are unresponsive to current therapies.

Psilocybin, the drug to be used in the trial, is a naturally occurring psychedelic prodrug produced by more than 200 fungi.

When used in combination with psychotherapy, a previous proof-of-concept study indicated that psilocybin may be effective for the treatment of people with alcohol dependence. 

Subject to ethics approval, the University of Sydney trial will be run in partnership with the Sydney Local Health District (Royal Prince Alfred Hospital) where this treatment will be delivered. It will aim to examine the safety, tolerability, and proof-of-concept efficacy of the drug for the treatment of alcohol use disorder in Australia.