A world-first investigator-initiated clinical trial at Macquarie University will test the effectiveness of regular, tiny doses of a psychedelic drug on moderate depression.
Australian emerging company Woke Pharmaceuticals, which is focused on psychedelic therapies for treatment of mental health, has developed a novel low-dose formulation of synthetic psilocybin, the active ingredient in magic mushrooms.
The company approached Macquarie University cognitive psychologist Dr Vince Polito to design and run a clinical trial to discover whether the product could be used as a treatment for depression.
While there is emerging evidence showing the effectiveness of high doses of psilocybin combined with psychotherapy as a treatment for various forms of mental illness, this trial is the first to test the effectiveness of regular, small, sub-hallucinogenic doses to treat depression.
Humans have been using magic mushrooms for their hallucinatory properties for thousands of years.
Dr Polito is an Australian leader in the field of psychedelics research, and is currently running a study to measure whether existing psylocibin microdosers experience improved creativity and other forms of cognitive enhancement.
“Humans have been using magic mushrooms for their hallucinatory properties for thousands of years,” Dr Polito says.
“Many cultures incorporated psychedelics such as psilocybin in their religious rituals, and in modern times these substances became popular during the 1960s, when they were an important part of the emerging counterculture.
“People continue to use psilocybin today, and regular microdosers have reported anecdotally that small amounts of the drug improve their moods and relieve the symptoms of depression.
“We’ll now be putting that to the test in a clinically controlled environment.”
No 'trips' for trial participants
An application in 2021 to Australia’s Therapeutic Goods Administration to down-schedule psilocybin as a controlled medication was rejected, pending further clinical data, and it remains a prohibited substance that is only available for research and development in strictly controlled circumstances.
Dr Polito has designed a double-blind clinical trial that will involve 266 adults over the age of 18 who experience moderate depression, the symptoms of which can impact an individual’s capacity to function normally.
The participants will be divided into two groups, with one group to receive two small doses of synthetic psilocybin in capsule form each week for six weeks, and the second receiving a placebo.
Each dose will contain up to 5mg of psilocybin. This is on the high end of what is considered a microdose, but substantially less than typical recreational doses, or doses used in previous psilocybin assisted psychotherapy trials, which are around 25mg.
We have great hopes that our formulation will prove to be an effective treatment for depression.
This means those involved in the trial will not experience the perceptual or cognitive changes that characterise a full psychedelic trip.
Participants will then undergo a range of tests and assessments including brain scans, regular psychological assessments and blood tests.
With very specific criteria required for the trial, including not taking traditional antidepressants, the team will not be calling for volunteers, instead relying on participating psychologists, psychiatrists and GPs to make referrals.
Nick Woolf, co-founder and CEO of Woke Pharmaceuticals, says the beginning of the clinical trial is an exciting time for the company.
“We have great hopes that our synthetic psilocybin formulation will prove to be an effective treatment for depression,” he says.
“Macquarie University was an obvious choice to run the trial because of its clinical track record, on‑site resources, and access to relevant expertise.
- What's stopping Australians from buying electric cars
- How to stop doom-scrolling and beat your bad news fatigue
“Dr Polito has assembled an exceptional interdisciplinary team that includes several of the most experienced psychedelic researchers within Australia, leading clinicians, and prominent senior scientists.”
Macquarie Medical School Deputy Dean (Research and Innovation) Professor Roger Chung sees the partnership with Woke Pharmaceuticals as an important initiative that draws upon the University’s expertise both in cognitive and neurosciences and in clinical trials design and management.
“The emerging research area of microdosing psilocybin as a potential treatment for depression is a challenging one to study, and Vince and the investigator team have developed a robust trial design to assess clinical efficacy,” he says.
“We’ll be watching these outcomes with interest in coming years.”
Macquarie is leading the trial, with collaborators from St Vincent’s Hospital, the Black Dog Institute, the George Institute, Monash University and the University of Sydney taking part.
The first participants are expected to begin their involvement early next year.
Dr Vince Polito is a Senior Research Fellow at Macquarie University’s School of Psychological Sciences
