Trial · NCT07909408
Psilocybin FCR Early-Stage Breast Cancer
NCT07909408, Phase 2, Not yet recruiting, NYU Langone Health
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Psilocybin FCR Early-Stage Breast Cancer. Trials, record NCT07909408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07909408
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Psilocybin FCR Early-Stage Breast Cancer
- NCT number
- NCT07909408
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- NYU Langone Health
- Conditions
- Early-stage Breast Cancer, Fear of Cancer Recurrence, Anxiety, Depression
- Interventions
- Psilocybin 25 mg, Psilocybin 5 mg
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) | Baseline, Week 4 Post-Dose Session | 9-item self-report questionnaire that measures the severity of worry or anxiety about cancer returning or progressing. Each item is rated on an individual Likert scale; the total score is the sum of responses and ranges from 0-36; higher scores indicate greater FCR. |
| Secondary | Change in Clinical Global Impression-Severity (CGI-S) Score | Baseline, Week 4 Post-Dose Session | Clinician-rated scale that measures symptom severity; measured using a 7-point scale rating the current severity of the patient's mental illness, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Secondary | Clinical Global Impression-Improvement (CGI-S) Score | Week 4 Post-Dose Session | Clinician-rated scale that measures symptom severity; measured using a 7-point scale assessing how much the patient's illness has improved or worsened relative to a baseline state, ranging from 1 (very much improved) to 7 (very much worse). |
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) Score | Baseline, Week 4 Post-Dose Session | The HADS combines 14 total self-report items (7 for anxiety \[HADS-A\] and 7 for depression \[HADS-D\]); each item is rated on a Likert scale from 0-3. The total score is the sum of responses and ranges from 0 to 42; higher scores indicate greater psychological distress. |
| Secondary | Change in Functional Assessment of Cancer Therapy-Breast (FACT-B) Score | Baseline, Week 4 Post-Dose Session | 37-item measurement of physical, emotional, social/family, and functional quality of life in breast cancer patients. Each item is rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-108; higher scores indicate Higher scores indicate better health-related quality of life. |
| Secondary | Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score | Baseline, Week 4 Post-Dose Session | 12-item measurement of spiritual well-being; each item is rated on a scale from 0-4; the total score ranges from 0 to 48, with higher scores indicating a higher level of spiritual well-being. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA312541 | Psilocybin-assisted Psychotherapy to Treat Fear of Cancer Recurrence in Early- Stage Breast Cancer | Ross, Stephen; FISCHER, STACY M | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | NATIONAL CANCER INSTITUTE | 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07909408
GET https://conductscience.org/api/trials/v1/NCT07909408/registered