Clinical Trials

Clinical Trials

Drug Science is a UK organisation that works to provide evidence-based R&D, and equipping the public, media and policy makers with the knowledge and resources to enact positive change. Drug Science’s mission is founded on delivering, reviewing, and investigating scientific evidence relating to psychoactive drugs.

Woke has partnered with Drug Science to develop and advise on the ground-breaking protocol of Woke’s novel high-dose psilocybin, WP002, with psychotherapy, for treatment-resistant depression. The Drug Science team includes one of the eminent leaders in psychedelics and founder of Drug Science, David Nutt, Professor of Neuropsychopharmacology and Director of the Neuropsychopharmacology Unit in the Division of Brain Sciences at Imperial College London. Professor Nutt is the Chief Scientific Advisor for the WP002 trial for treatment-resistant depression. 

“Professor Nutt and the team at Drug Science are exceptionally knowledgeable and experienced in the design of psychedelic clinical trials. With Drug Science, Woke has designed a ground-breaking Phase IIB trial to evaluate WP002 in patients with treatment-resistant depression.

Macquarie University is a public research university based in Sydney, Australia, in the suburb of Macquarie Park. Founded in 1964 by the New South Wales Government, it was the third university to be established in the metropolitan area of Sydney. 

Woke and Macquarie University have entered an agreement to conduct a ground-breaking Phase IIB trial of Woke’s novel low-dose (microdose) psilocybin, WP001, to treat moderate depression. The Principal Investigator, Dr Vince Polito, a Senior Research Fellow in the Department of Cognitive Science at Macquarie University, has focused much of his work on investigating the ways that altered states and, in particular, psychedelics might impact consciousness and cognition. Dr Polito is a leading researcher in the field of psychedelic microdosing. He has assembled a first-rate team of experts to support the trial.

“Macquarie University's Dr Polito is a leading clinician in the field of microdosing psilocybin and has assembled an exceptional interdisciplinary team that includes several of the most experienced psychedelic researchers within Australia, to conduct this Phase IIB trial of Woke’s WP001 for treatment of moderate depression.”

QIMR Berghofer is a world-leading, translational medical research institute that seeks to discover, diagnosis and deliver better treatments for some of the world’s deadliest and most debilitating diseases. The Brisbane institute’s team of scientists, support staff, and students have a mission to achieve better health through medical research, focusing on the fields of cancer, inflammation, infection, population health, mental health, and neuroscience. 

Woke and QIMR Berghofer have signed a Letter of Intent to conduct a feasibility trial of Woke’s novel high-dose psilocybin, WP002, for treatment of prolonged grief disorder. The Principal Investigator, Associate Professor Vanessa Beesley, is an expert in behavioural science and Team Head of the Supportive Care in Cancer Group at QIMR Berghofer.

“With QIMR Berghofer, Woke is evaluating WP002 to treat prolonged grief, which affects a vast number of people and could offer a new treatment option with durable benefit. Associate Professor Beesley and her team have extensive knowledge and experience in this field.”

Swinburne University of Technology is a public research university based in Melbourne, Australia. With outstanding researchers and facilities, specialist institutes and centres, strategic platforms and initiatives, and a focus on high-quality and ethically sound research, Swinburne is ranked among the top 300 research-intensive universities in the world. 

Woke and Swinburne University of Technology have signed a Memorandum of Understanding to conduct the Phase IIB trial of WP002 for treatment-resistant depression. The prospective Principal Investigator, Professor Susan Rossell, is a cognitive neuropsychologist and Professorial Research Fellow at Swinburne’s Centre for Mental Health. 

“Swinburne University of Technology is leading the renaissance of clinical research of psychedelic therapies to treat mental health disorders in Australia. Professor Rossell and her team are well placed to conduct and lead Woke’s flagship Australian Phase IIB trial of WP002 psilocybin-assisted psychotherapy for treatment-resistant depression.”

The University of Sydney is one of the world’s leading, comprehensive research and teaching universities. Their aim is to make lives better not just by producing leaders of society, but through equipping their people with the qualities that allow them to serve all communities at every level. Currently ranked 4th in the world in the QS Graduate Employability Rankings and 41st in the QS World University Rankings, the University of Sydney is also consistently placed among the top universities in the world. 

Woke and the University of Sydney have signed a term sheet to conduct a Phase II trial of WP002 in patients with alcohol use disorder. Professor Paul Haber and Associate Professor Kirsten Morley from the University’s Faculty of Medicine and Health will lead the trial. The planned randomised controlled Phase II trial is expected to enrol approximately 60 patients to evaluate safety, tolerability, and proof of concept efficacy of WP002.

The team at University of Sydney is first rate and experienced in conducting clinical trials using psilocybin-assisted psychotherapy. With knowledge and expertise in the treatment of substance abuse, the University of Sydney is well placed to conduct this Phase II trial that is designed to evaluate whether WP002 is safe and can benefit patients suffering from alcohol use disorder."