This interventional trial (n=12) aims to assess the safety and tolerability of psilocybin-assisted physiotherapy (5-20mg) in healthy volunteers.
The study seeks to understand the feasibility of performing basic movement tasks prescribed by a physiotherapist after the administration of psilocybin. 12 healthy participants will receive three separate doses of psilocybin (5mg, 10mg, 15mg, or 20mg) according to a Williams study design, with each dose taken at least one week apart.
The trial is approved by the Austin Health Human Research Ethics Committee. The primary outcome measures include the participants’ ability to complete movement tasks and the occurrence of adverse events following each dose of psilocybin. Secondary outcomes include participants’ experiences of the intervention, performance on a computer task assessing sense of motor agency, and changes in brain functional connectivity measured via resting state fMRI scans.
The study is conducted by Prof Richard Kanaan and funded by Austin Health, the Melbourne School of Psychological Sciences (University of Melbourne), and the Usona Institute. Recruitment is ongoing in Australia, with a target of 12 participants. Data sharing for individual participant data (IPD) is not planned.
Trial Details
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Sponsors & Collaborators
Usona InstituteThe Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).