Safety and tolerability of psilocybin-assisted physiotherapy in healthy volunteers

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

Functional Neurological Disorder is a common neuropsychiatric condition which is often chronic and results in debilitating symptoms such as paralysis or abnormal movement. The symptoms of Functional Neurological Disorder are not caused by structural abnormalities within the brain or nervous system but instead arise through psychological processes. Current treatments for Functional Neurological Disorder have limited efficacy. It is thought that drugs belonging to a class known as psychedelics, when administered in conjunction with a physiotherapy regime, may be particularly effective in the treatment of Functional Neurological Disorder but this therapeutic intervention has not been investigated in a clinical trial. Therefore, this study will assess the safety and feasibility of a physiotherapy regime designed for the treatment of Functional Neurological Disorder after administration of psilocybin in healthy volunteers.

NCT Number ACTRN12621000560897

Data attribution

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