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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06430541
The ClinicalTrials.gov registry entry for NCT06430541 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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Related
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