Clinical TrialHealthy VolunteersPsilocybinRecruiting

Safety and tolerability of psilocybin-assisted physiotherapy in healthy volunteers

This interventional trial (n=12) assesses safety and tolerability of psilocybin-assisted physiotherapy (three oral sessions, 5-20 mg Williams design) in healthy volunteers.

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

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.

Study Protocol

Preparation

1 sessions

Dosing

3 sessions
300 min each

Integration

2 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin + physiotherapy

experimental

Single-group, uncontrolled Williams design testing three oral psilocybin doses per participant with physiotherapist-prescribed movement tasks.

Interventions

  • Psilocybin5 - 20 mg
    via Oral• three sessions• 3 doses total

    Williams design: cohort A receives 5,10,15 mg; cohort B receives 10,15,20 mg; doses randomly ordered; ≥1 week washout between sessions.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Adults aged 18 to 65 years without a history of Functional Neurological Disorder (FND); capacity to provide informed consent; volunteer participants.

Exclusion Criteria

  • Medical exclusion criteria:
  • Poorly-controlled hypertension, angina, ischaemic heart disease, clinically significant ECG abnormality (e.g. atrial fibrillation), transient ischaemic attack (TIA), stroke, peripheral or pulmonary vascular disease (no active claudication).
  • Diagnosis of epilepsy or previous epileptic seizures.
  • Diagnosis of dementia.
  • History of chronic kidney disease or chronic liver disease.
  • Known conditions putting participant at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, SIADH, or carcinoid syndrome.
  • Insulin-dependent diabetes; if on oral hypoglycaemics, excluded if history of hypoglycaemia.
  • Females who are pregnant, nursing or trying to conceive.
  • Use of medications contraindicated with psilocybin or that cannot be ceased for required periods.
  • Patients enrolled in another clinical trial involving an investigational product.
  • Psychological exclusion criteria:
  • Current or previous diagnosis of any psychotic disorder (including schizophrenia spectrum or substance/medication-induced psychotic disorder).
  • Current or previous diagnosis of bipolar disorder.
  • First-degree relative with diagnosed schizophrenia, psychotic disorder, or bipolar disorder.
  • History of attempted suicide or mania.
  • Current or previous diagnosis of substance use disorder (excluding caffeine and nicotine).
  • Previous regular use, or current use, of psychedelic agents.
  • Current diagnosis of other psychiatric conditions judged incompatible with safe exposure to psilocybin.

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2023-07-09
    End: 2024-02-09
  • Compound
    Psilocybin
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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