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Psychedelics for alcohol use disorder

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Science & technology, Australia (Commonwealth Union) – Alcohol disorders have been both a personal and social hazards through out the ages, with uncontrolled alcohol use often during recreational events, where excessive drinking can lead to irresponsible behavior such as public disturbance and drunk driving. Alcohol disorders can also lead to several health disorders such as liver disease, diabetes as alcohol can blood sugar levels and heart disease.

Researchers at the University of Sydney are examining ways to assist persons with alcohol disorders in an Australian 1st research trial into the application of psychedelics together with psychotherapy.

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

The University is planning to carry out a randomized placebo-controlled Phase IIB trial of a novel synthetic formulation of the naturally occurring psychedelic, psilocybin, produced by Woke Pharmaceuticals Pty Ltd. The trial is set up to gather participants with alcohol use disorder who have had no response to the present treatments.

Principal Investigator Professor Paul Haber from the University of Sydney and Sydney Local Health District pointed out that alcohol has a significant effect on public health, bringing about issues of disease impacting people, 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,” explained Professor Haber, who is also 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.”

Across the globe, roughly 3.8% of all deaths and 4.6% of disability-adjusted life-years have been associated with alcohol. By 2030, alcohol use disorder is estimated to be the 4th main cause of disability in high-income nations.

Psilocybin, the drug that is to be utilized in the trial, is a naturally occurring psychedelic prodrug synthesized by over 200 fungi.

When utilized together with psychotherapy, a prior proof-of-concept study pointed to the fact that psilocybin may give positive outcomes for the treatment of individuals dependent on alcohol. The findings were recently replicated by the same authors in a wider trial with 95 participants.

 “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,” said Nick Woolf, CEO and Director of Woke Pharmaceuticals.

On the condition of an ethics approval, the University of Sydney trial is to be conducted in collaboration with the Sydney Local Health District at the Royal Prince Alfred Hospital where this treatment is set to be carried out. The research hopes to explore the safety, tolerability, and proof-of-concept efficacy of the drug for its application on alcohol use disorder in Australia.

 “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,” said Professor Morley.

Even though there is an increased interest in the part of psychedelic-assisted treatments for mental health disorders, this area remains in its infancy. Presently clinical trial results remain preliminary and high-quality clinical research will be needed from 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.

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