🏛️ Verified NIH Record • Updated 2026-07-08

Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT) (NCT07063862)

PSilocybin Microdose for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site Phase 3 Double-blind, Placebo-controlled, Parallel-arm Clinical Trial

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Bruyère Health Research Institute.

🩺 Plain-English Summary (8th-Grade Level)

About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress. Treatment options such as medication and therapy are available; however, they do not always work and can be time-consuming and expensive. We need treatments that work well, quickly, and can be available to all patients with advanced illness who have psychological distress. Psilocybin, a psychedelic medication (commonly called 'magic mushrooms') works well for improving psychological distress in people with cancer or chronic illness when given in high doses with specific forms of therapy. However, psilocybin has not been well-studied among people with advanced illness, and there are concerns about safety and side effects in people approaching the end of life. However, reports on psilocybin microdosing, which involves taking small doses that do not cause hallucinations and do not require therapy, suggest that this may be effective, safer, and more acceptable for people with advanced illness. We recently completed a small study of psilocybin microdosing. Our results showed psilocybin microdose improved psychological distress in most participants with advanced illness, without serious side effects. Our next step is to do a randomized clinical trial where some patients receive psilocybin microdose and some receive placebo (a drug that contains no medicinal ingredients). By comparing these two groups, we can remove the possibility that improvements in symptoms are only because patients thought they were getting treatment. We will enroll 120 patients from inpatient, outpatient, and community care settings across seven sites. Participants in the microdose psilocybin group will receive 2 or 3 mg of psilocybin daily, 4 days per week, for two consecutive weeks. The placebo group will receive placebo with the same treatment schedule. All participants will be offered microdose psilocybin after 2-week follow-up. If this study is successful, we have the potential to change how psychological distress is managed in patients with advanced illness.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (19 items).

Location: William Osler Health System — Brampton, Ontario

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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
  • Inability to complete assessments via telephone or video-conferencing platform
  • Severe or unstable physical symptoms based on the judgment of the palliative care provider
  • Palliative Performance Scale (PPS) \<50%\*
  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

  • William Osler Health System — Brampton, Ontario
  • Providence Care Hospital — Kingston, Ontario
  • St. Joseph's Healthcare — London, Ontario
  • South Lake Regional Health Centre — Newmarket, Ontario
  • Bruyere Health — Ottawa, Ontario
  • The Ottawa Hospital — Ottawa, Ontario
  • McGill University Health Centre — Montreal, Quebec

📞 Contact the Study Coordinator

Phone: (613) 562-6262

Email: jdownar@toh.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Psychological Distress

Explore by condition: All Psychological Distress clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗