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NCT06644170 · ClinicalTrials.gov registry record · Phase 1
A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT06644170: Completed Phase 1 study, sponsored by University of Washington.
NCT06644170 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06644170, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a partial response to their first retreat. Up to 50% of patients with metastatic cancer have clinically significant anxiety and unaddressed anxiety and distress may add to the suffering caused by cancer itself. Psilocybin, a psychedelic drug, is made using an extract from the psilocybe mushroom, also known as "magic mushrooms". Psilocybin binds to serotonin receptors (natural body chemicals that control moods) on brain cells producing intense changes in mood, including anxiety. This may change perceptions and patterns of thinking in ways that may decrease anxiety. Group therapy may reduce stress and improve the well-being and quality of life of patients with metastatic cancer. A second episode of psilocybin-assisted group therapy may be safe, tolerable and or effective in treating anxiety and distress in partial responders with metastatic cancer.
Primary Outcome
AEs will be defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product. AEs will be graded in severity using mild, moderate and severe. Occurrence of any adverse event graded severe on the Common Terminology Criteria for Adverse Events patient-reported questionnaires. Descriptive statistics will be used to analyze all adverse events, and in particular severe adverse events.
Interventions
- OTHER Questionnaire Administration
- DRUG Psilocybin
- BEHAVIORAL Behavioral Intervention
- BEHAVIORAL Group Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-11-19 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 1 |
What the finished NCT06644170 record still lists
NCT06644170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT06644170 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06644170 about?
NCT06644170 is a clinical study titled "A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer". This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a p...
What is the current status of trial NCT06644170?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-11-19. Estimated completion is 2025-09-30.
What interventions are being tested in trial NCT06644170?
The interventions under investigation include: Questionnaire Administration (OTHER), Psilocybin (DRUG), Behavioral Intervention (BEHAVIORAL), Group Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT06644170?
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 NCT06644170's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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