CompletedPhase 1ACTRN12621000560897

Safety and tolerability of psilocybin-assisted physiotherapy in healthy volunteers

Sponsor

Austin Health

Enrollment

12 participants

Start Date

Jul 9, 2023

Study Type

Interventional

Conditions

Functional neurological disorder

Summary

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria2

Adults aged 18 to 65 years, without a history of Functional Neurological Disorder (FND), who have volunteered for the study.
Capacity to provide informed consent

Exclusion Criteria16

Cardiovascular conditions: poorly-controlled hypertension, angina, ischemic heart disease, a clinically significant ECG abnormality (e.g. atrial fibrillation), transient ischemic attack (TIA), stroke, peripheral or pulmonary vascular disease (no active claudication).
A diagnosis of epilepsy or previous epileptic seizures.
Diagnosis of dementia
A history of Chronic Kidney Disease or Chronic Liver Disease
Known conditions putting the participant at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome.
Insulin-dependent diabetes; if taking oral hypoglycaemic agents, the participant is only excluded if they also have a history of hypoglycaemia.
Females who are pregnant, nursing or trying to conceive.
Use of medications contraindicated with psilocybin, that are inappropriate to cease for the necessary time period before/after the dosing session.
Patients enrolled in another clinical trial involving an investigational product.
Current or previous diagnosis of any psychotic disorder, including Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Brief Psychotic Disorder, Delusional Disorder, Schizotypal Personality Disorder, Substance/Medication-Induced Psychotic Disorder or Psychotic Disorder due to another medical condition.
Current or previous diagnosis of Bipolar disorder.
First degree relative with diagnosed Schizophrenia, Psychotic Disorder, or Bipolar Disorder.
A 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 to be incompatible with safe exposure to psilocybin

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Interventions

This feasibility and pilot study will assess the safety and tolerability of performing basic movement tasks (prescribed by a physiotherapist) following administration of psilocybin in healthy volunteers. The findings from this study will be used to guide the dosage of psilocybin in the companion study (‘Psilocybin-assisted therapy for refractory Functional Neurological Disorder’). 12 healthy participants will be recruited on a volunteer basis for this study. Each participant will receive three separate doses of psilocybin (5mg, 10mg, 15mg or 20mg) according to a Williams study design. Six participants will receive 5, 10 & 15mg and six will receive 10, 15 & 20mg. Each dose will be randomly assigned and taken at least 1 week apart. After providing written consent to participate in the study, participants will be assessed by a physician and psychiatrist to ensure study eligibility criteria is satisfied. If eligible, a preparation session facilitated by a mental health professional (for example, a psychiatrist or psychologist) will occur approximately one week before the participant’s first psilocybin dosing session. This will take place in dedicated room at the Austin Hospital where the dosing sessions will occur. The preparation session will consist of a discussion about drug administration, the psychoactive effects of psilocybin, and a trial of the movement tasks that will be performed during each dosing session (see below). Participants will be encouraged to raise any queries or concerns they have about the study which will be addressed by the mental health professional. On the day of psilocybin administration, the participant will arrive approximately 1 hour before dosing so trial staff can re-confirm their eligibility (including review of medication status), and record baseline vital sign measurements (heart rate, blood pressure, pulse oximetry). Psilocybin will be administered orally (capsule form) with a glass of water under the supervision of trial staff. Vital signs will be checked at hourly intervals up to 5 hours after dosing. Throughout each dosing session, participants will be asked to complete a series of movement tasks adapted from the De Morton Mobility Index and the Physio4FMD randomised controlled trial (de Morton NA, Davidson M, Keating JL, 2008; Nielsen G, et al., 2019). The trial physiotherapist will assess the participant’s ability to complete each task following an assessment form created by the researchers for the purposes of this study. At the end of each dosing session, the participant will be provided an opportunity to debrief with trial staff about their experiences, including adverse events. They will also be contacted by trial staff the following morning to assess for delayed side effects/adverse events since leaving the hospital. In addition, participants will be asked to complete a resting state fMRI brain scan prior to their first and second dose of psilocybin (baseline and follow-up scans respectively).