Status:
RECRUITING
PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Bruyère Health Research Institute.
The Ottawa Hospital
Conditions:
Depression, Anxiety
Distress, Emotional
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychologic...
Detailed Description
Patients with advanced illness report feeling a sense of hopelessness, loss of autonomy and relationships, and a lack of purpose in life. These feelings of psychological suffering have been described ...
Eligibility Criteria
Inclusion
- Patients \>/=18 years of age
- Advanced illness under palliative care management, defined as having 1 to \<12 months life expectancy (in the judgment of the palliative care provider)
- Experiencing psychological distress, defined as a score of 7 or greater on the Depression, Anxiety or Well-being item of the Edmonton Symptom Assessment System
- Ability to understand and communicate in English or French
Exclusion
- Current or previously diagnosed, or first-degree relative, with psychotic or bipolar disorder
- Previously deemed eligible for MAiD with intention to proceed with MAiD regardless of study intervention effectiveness (this criteria is meant to exclude patients who would be unlikely to complete follow-up - those considering or being assessed for MAiD will still be eligible)
- Documented or suspected delirium in the past 3 months without a clearly defined reversible cause (e.g. opioid toxicity, infection) and resolution
- Documented moderate or severe dementia diagnosis
- Inability to provide first-person informed consent
- Severe or unstable physical symptoms based on the judgment of the palliative care provider
- Palliative Performance Scale \<30%
- Cancer with known central nervous system (CNS) involvement or other CNS disease
- Use of high-dose psychedelic substances in the past year
- Taking lithium at any dose
- Taking tramadol at any dose
- Taking any monoamine oxidase inhibitor at any dose \[American Hospital Formulary Service (AFHS) group 28:16.04.12 or 28:36.32, including, but not limited to, moclobemide, tranylcypromine, phenelzine, selegiline, rasagiline\]
- Taking any atypical antipsychotic (aripiprazole, asenapine, brexpiprazole, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone) (patients can be included if their atypical antipsychotic is either stopped, or if appropriate, substituted with haloperidol 48 hours prior to the start and for the duration of the intervention period and follow-up)
- Inability to ingest oral capsule
- Pregnancy or lactation
- For participants taking either an SSRI or an antipsychotic medication, there are several conditions for participation: (1) the PC provider must approve their participation in the study; (2) the SSRI/anti-psychotic medication dose cannot change for the duration of the intervention trial and follow-up, and; (3) the patient must not be taking more than the maximum allowable trial dose for each SSRI.
- All trial participants must agree to not take any other psychedelic substance for the duration of the clinical trial and follow-up, and to notify the investigative team of any medication changes during intervention or follow-up. Participants must also agree not to take their benzodiazepine or antipsychotic medication, if applicable, within 12 hours (6 hours pre and 6 hours post) of taking their psilocybin dose (participants will be given detailed instructions about this in their Instruction Leaflet). Participants must also agree not to drive or operate any heavy machinery on any treatment day for the duration of the 4-week intervention.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04754061
Start Date
January 8 2024
End Date
June 1 2025
Last Update
August 9 2024
Active Locations (2)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
2
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1R 6K9