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Safety and tolerability of psilocybin-assisted physiotherapy in healthy volunteers
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This interventional trial (n=12) assesses safety and tolerability of psilocybin-assisted physiotherapy (three oral sessions, 5-20 mg Williams design) in healthy volunteers.
Details
Single-group feasibility pilot in healthy volunteers using a Williams design: each participant receives three oral psilocybin doses (cohort A: 5,10,15 mg; cohort B: 10,15,20 mg) in sessions at least one week apart; doses are randomly ordered.
Primary assessments include physiotherapist-prescribed movement tasks (adapted from the DEMMI and Physio4FMD), hourly vital signs up to 5 hours post-dose, resting-state fMRI (baseline and after second dose), adverse-event monitoring with debrief and next-day phone follow-up, and qualitative interviews after final dose.
Topics:Healthy Volunteers
Registry
Registry linkACTRN12621000560897