Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID04754061

PSilocybin for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL): Multi-site, Open-label, Single Arm Phase I/II Proof-of-concept, Dose-finding, and Feasibility Trial

Led by Ottawa Hospital Research Institute · Updated on 2024-08-09

20

Participants Needed

2

Research Sites

21 weeks

Total Duration

On this page

Sponsors

O

Ottawa Hospital Research Institute

Lead Sponsor

B

Bruyère Health Research Institute.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate psilocybin microdosing as a potential treatment for psychological distress, including depression and anxiety, in patients with advanced illness receiving palliative care. Psychological and existential suffering at the end of life can lead to poor quality of life and increased desire for hastened death. Current treatments have limited effectiveness and may not be suitable for patients nearing the end of life, highlighting the need for new, scalable approaches. Psilocybin microdosing, involving small, sub-hallucinogenic doses taken over time, is being studied for its safety, feasibility, and preliminary efficacy in this population. Participants will take oral psilocybin capsules starting at 1 mg once daily on Mondays and Thursdays during the first week, increasing dose weekly up to 3 mg daily by the fourth week, Monday through Friday. This 4-week treatment does not require special supervision during dosing, potentially making it more acceptable and easier to scale than previous larger-dose psilocybin therapies. The study is open-label and single-arm, with all 40 participants receiving psilocybin microdosing to assess recruitment, dosing, safety, and initial effects. During the study, participants will self-administer the capsules and be monitored for adverse events such as changes in blood pressure, heart rate, mood, or delirium. Researchers will track psychological distress weekly and at follow-up visits up to 24 weeks after treatment. Quality of life, existential distress, and overall well-being will also be assessed through questionnaires. The study will evaluate recruitment and intervention completion rates up to 18 months, providing data on safety, feasibility, and early signs of benefit in this group.

CONDITIONS

Brief Title

PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Have advanced illness under palliative care with life expectancy between 1 and less than 12 months
  • Experiencing psychological distress with a score of 7 or greater on the Edmonton Symptom Assessment System
  • Able to understand and communicate in English or French
Not Eligible

You will not qualify if you...

  • Current or past diagnosis of psychotic or bipolar disorder, or first-degree relative with these conditions
  • Previously deemed eligible for medical assistance in dying (MAiD) with intention to proceed regardless of study
  • Delirium in the past 3 months without a reversible cause and resolution
  • Moderate or severe dementia diagnosis
  • Unable to provide informed consent personally
  • Severe or unstable physical symptoms as judged by palliative care provider
  • Palliative Performance Scale less than 30%
  • Cancer involving the central nervous system or other CNS disease
  • Use of high-dose psychedelic substances in the past year
  • Taking lithium, tramadol, or any monoamine oxidase inhibitor
  • Taking any atypical antipsychotic unless stopped or replaced with haloperidol 48 hours before and during the study
  • Unable to swallow oral capsules
  • Pregnancy or breastfeeding
  • Taking SSRIs or antipsychotics only with palliative care provider approval, stable dose, and within allowable limits
  • Agree not to take other psychedelic substances during the trial and follow-up
  • Agree not to use benzodiazepines or antipsychotics within 6 hours before or after psilocybin doses
  • Agree not to drive or operate heavy machinery on treatment days for 4 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants will receive a 4-week psilocybin microdosing intervention, starting with a 1mg dose once per day on Monday and Thursday in week 1, increasing doses each week up to 3mg per day from Monday to Friday as tolerated.

Daily dosing Monday to Friday for up to 4 weeks with weekly visits for assessment

Follow-up

Duration - Up to 24 weeks

Participants will be monitored after treatment to assess psychological distress, quality of life, and any adverse events at multiple timepoints up to 24 weeks after intervention completion.

Visits at 1 day, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post-treatment

Trial Site Locations

Total: 2 locations

1

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

2

Bruyere Continuing Care

Ottawa, Ontario, Canada, K1R 6K9

Actively Recruiting

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Research Team

J

James Downar, MDCM, MSc

J

Julie Lapenskie, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Screening for delirium using family caregivers: convergent validity of the Family Confusion Assessment Method and interviewer-rated Confusion Assessment Method.

Melinda R Steis, Lois Evans, Karen B Hirschman...

https://pubmed.ncbi.nlm.nih.gov/23039310

Diagnostic validity of the Hospital Anxiety and Depression Scale (HADS) in cancer and palliative settings: a meta-analysis.

Alex J Mitchell, Nick Meader, Paul Symonds

https://pubmed.ncbi.nlm.nih.gov/20207007

A multicenter study comparing two numerical versions of the Edmonton Symptom Assessment System in palliative care patients.

Sharon M Watanabe, Cheryl Nekolaichuk, Crystal Beaumont...

https://pubmed.ncbi.nlm.nih.gov/20832987

The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group.

S M Skevington, M Lotfy, K A O'Connell...

https://pubmed.ncbi.nlm.nih.gov/15085902