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NCT05847686 · ClinicalTrials.gov registry record · Phase 1
Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT05847686: Completed Phase 1 study, sponsored by University of Washington.
NCT05847686 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05847686, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety and/or depression. Psilocybin is a substance being studied in conjunction with therapy for the treatment of anxiety and depression in patients with cancer. In this study, the psilocybin being used is derived from the mushroom psilocybe cubensis using a patented process that results in a pharmaceutical grade version of psilocybin. Psilocybin acts by activating serotonin receptors on brain cells which can change perceptions and patterns of thinking in ways that may decrease anxiety.
Primary Outcome
Defined as the occurrence of participant distress among study participants in the small group during the psilocybin administration session on Day 0 that requires 1:1 facilitator attention that cannot be met by the 4-person facilitation team. The size of small groups of different sizes will vary over the course of the study. Descriptive statistics will be used to analyze and will be tabulated on Day 0 after each group intervention. Backup facilitators will be available when this occurs.
Interventions
- OTHER Questionnaire Administration
- DRUG Psilocybin
- OTHER Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2024-10-17 |
| Phase | Phase 1 |
What the finished NCT05847686 record still lists
NCT05847686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Questionnaire Administration is the first listed.
NCT05847686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05847686 about?
NCT05847686 is a clinical study titled "Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer". This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety and/or depression. Psilocybin is a substance being studied in conjunction with therapy for the treatment of anxiety and depre...
What is the current status of trial NCT05847686?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2023-06-27. Estimated completion is 2024-10-17.
What interventions are being tested in trial NCT05847686?
The interventions under investigation include: Questionnaire Administration (OTHER), Psilocybin (DRUG), Counseling (OTHER).
Who is sponsoring clinical trial NCT05847686?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05847686's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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