A Phase 2 interventional study of Psilocybin 25 mg and Psilocybin 5 mg in Early-stage Breast Cancer, Fear of Cancer Recurrence and Anxiety, sponsored by NYU Langone Health. Not yet recruiting at 2 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment
This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat fear of cancer recurrence (FCR), psychiatric (anxiety, depression) distress and quality-of-life (QOL), in 100 outpatients with early-stage breast cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center randomized controlled trial (RCT) comparing a single 25mg oral 'high' dose of psilocybin to a single 5mg oral 'low dose psilocybin (active placebo), both delivered in conjunction with a psychotherapy platform.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 medication session lasting approximately 8 hours
Drug: Psilocybin 25 mg
1 medication session lasting approximately 8 hours
Drug: Psilocybin 5 mg
Experimental dose
Active comparator dose
Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)
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.
Time frame: Baseline, Week 4 Post-Dose Session
Change in Clinical Global Impression-Severity (CGI-S) Score
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).
Time frame: Baseline, Week 4 Post-Dose Session
Clinical Global Impression-Improvement (CGI-S) Score
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).
Time frame: Week 4 Post-Dose Session
Change in Hospital Anxiety and Depression Scale (HADS) Score
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.
Time frame: Baseline, Week 4 Post-Dose Session
Change in Functional Assessment of Cancer Therapy-Breast (FACT-B) Score
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.
Time frame: Baseline, Week 4 Post-Dose Session
Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score
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.
Time frame: Baseline, Week 4 Post-Dose Session
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Stephen.ross@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
Access criteria: Requests should be directed to Stephen.ross@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Psilocybin