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 Pty Ltd. The trial is designed to recruit participants with alcohol use disorder who are unresponsive to current therapies.
Principal Investigator Professor Paul Haber from the University of Sydney and Sydney Local Health District said alcohol has a major impact on public health, leading to a large burden of disease affecting individuals, families and the health system.
“Alcohol use is directly related to cardiovascular disease, mental health conditions, digestive diseases, several forms of cancer and devastating physical injuries,” said Professor Haber, Head of the Specialty of Addiction Medicine at the University and Clinical Director for Drug Health Services at Royal Prince Alfred Hospital.
“We urgently need to develop new and effective ways to help people with alcohol problems. We are excited to build on the early evidence that psilocybin may be a step forward in treatment.”
We urgently need to develop new and effective ways to help people with alcohol problems. We are excited to build on the early evidence that psilocybin may be a step forward in treatment.
World-wide, approximately 3.8 percent of all deaths and 4.6 percent of disability-adjusted life-years are attributable to alcohol. By 2030, alcohol use disorder is estimated to be the fourth leading cause of disability in high-income countries.
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. These results were recently replicated by the same authors in a larger trial involving 95 participants.
Nick Woolf, CEO and Director of Woke Pharmaceuticals, commented, “We are delighted to support this exciting trial with the team at the University of Sydney to address the growing unmet medical need of alcohol use disorder. Professors Haber and Morley have the knowledge and expertise to conduct this pioneering Phase IIB trial of Woke’s novel rapid-release tablet formulation of psilocybin.”
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.
Professor Haber and co-investigator Professor Kirsten Morley, both from the University’s Faculty of Medicine and Health, have collaborated on many clinical trials for the treatment of substance use disorders over the past twenty years and are among the leading Australian researchers in this field.
Professor Morley said: “This is an exciting new opportunity, and we really need well-designed and robust trials to provide strong evidence around the use of psychedelics for therapeutic purposes.”
While there is growing interest in the role of psychedelic-assisted treatments for mental health disorders, this field of research is still in its infancy. Current clinical trial results remain preliminary and high-quality clinical research is required by experienced researchers.
The University of Sydney has an expanding program of work in this space and this trial will add to a portfolio of internationally innovative research using psychedelic medications for mental health disorders.
The University is currently leading two other closely aligned trials supported by the Medical Research Future Fund (MRFF). Professors Haber and Morley are studying the effects of MDMA-assisted therapy on people with both alcohol use disorder and PTSD, a common and disabling combination (2022/ETH00773). The other MRFF-funded trial at the University of Sydney is investigating the use of psilocybin treatment for anorexia nervosa (undergoing ethics approval).
Declaration: The proposed clinical trial is subject to regulatory and ethics approval. Under the terms of the agreement, Woke Pharmaceuticals will support the trial financially and in kind by supplying the drug and placebo. Woke Pharmaceuticals will not be involved in the study design, conduct and collection or interpretation of the data.