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NCT06430541 · ClinicalTrials.gov registry record · Phase 1
Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
A Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06430541: Recruiting Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by University of Colorado, Denver.
NCT06430541 is a Phase 1 study of Breast Cancer and Ovarian Cancer that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 20 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06430541, a Phase 1 study of Breast Cancer and Ovarian Cancer, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.
Primary Outcome
Measured by change in core on the Fear of Recurrence Inventory completed at screening and baseline. The FCRI's total score ranges from 0 to 36, with higher scores indicating greater FCR severity.
Conditions Studied
Interventions
- DRUG Psilocybin
Study Locations (2)
Colorado
- Outpatient CTRC - Aurora
- University of Colorado Cancer Center - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-11-21 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT06430541 shows while recruiting
NCT06430541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin is the first listed.
NCT06430541 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06430541 about?
NCT06430541 is a clinical study titled "Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence". The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recur...
What is the current status of trial NCT06430541?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-11-21. Estimated completion is 2028-12.
What conditions does trial NCT06430541 study?
This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer.
What interventions are being tested in trial NCT06430541?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT06430541?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06430541 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06430541's enrollment target sits among peer trials
20 1079th of 1224 higher than 112 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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