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

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Feb 12, 2021

Keywords

ClinConnect Summary

The PSYCHED-PAL trial is studying the use of a substance called psilocybin, which is derived from mushrooms, to help patients with advanced illnesses who are experiencing emotional distress, such as depression and anxiety. This study is looking to see if taking small amounts of psilocybin (called microdosing) can improve patients' mental well-being. Participants in the trial will take a daily dose of psilocybin for four weeks and will be monitored for any side effects and changes in their emotional health.

To be eligible for the trial, participants must be at least 18 years old, be receiving palliative care (which means they are in the later stages of a serious illness), and have a certain level of psychological distress as shown by a simple test. The study is open to all genders, but people with certain mental health conditions or severe physical symptoms may not qualify. Throughout the trial, participants will receive guidance on what to expect, including restrictions on certain medications, and will be asked to refrain from driving or operating heavy machinery on days they take psilocybin. This trial is currently recruiting participants and aims to provide insights into how psilocybin can help improve quality of life for those facing serious health challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients \>/=18 years of age
• • 2. Advanced illness under palliative care management, defined as having 1 to \<12 months life expectancy (in the judgment of the palliative care provider)
• • 3. 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
• • 4. Ability to understand and communicate in English or French
• Exclusion Criteria:
• • 1. Current or previously diagnosed, or first-degree relative, with psychotic or bipolar disorder
• • 2. 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)
• • 3. Documented or suspected delirium in the past 3 months without a clearly defined reversible cause (e.g. opioid toxicity, infection) and resolution
• • 4. Documented moderate or severe dementia diagnosis
• • 5. Inability to provide first-person informed consent
• • 6. Severe or unstable physical symptoms based on the judgment of the palliative care provider
• • 7. Palliative Performance Scale \<30%
• • 8. Cancer with known central nervous system (CNS) involvement or other CNS disease
• • 9. Use of high-dose psychedelic substances in the past year
• • 10. Taking lithium at any dose
• • 11. Taking tramadol at any dose
• • 12. Taking any monoamine oxidase inhibitor at any dose \[American Hospital Formulary Service (AFHS) group 28:16.04.12 or 28:36.32, including, but not limited to, moclobemide, tranylcypromine, phenelzine, selegiline, rasagiline\]
• • 13. 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)
• • 14. Inability to ingest oral capsule
• • 15. 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.