Early-stage Breast CancerPhase 2NCT07909408
Psilocybin FCR Early-Stage Breast Cancer
A Phase 2 study testing Psilocybin 25 mg and Psilocybin 5 mg in people with Early-stage Breast Cancer and Fear of Cancer Recurrence, run by NYU Langone Health at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Early-stage Breast Cancer, Fear of Cancer Recurrence, Anxiety
- What is being tested?
- Psilocybin 25 mg and Psilocybin 5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2027to 31 Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 21
- Females
- Diagnosis of Stage 1 or 2 Estrogen/Progesterone Receptor-Positive (ER/PR +), Human Epidermal growth factor Receptor 2 negative (HER2-) breast cancer
- Having completed initial treatment (e.g. surgery, chemotherapy, radiotherapy) for breast cancer (ongoing adjuvant endocrine, and/or HER2 therapy allowed)
- At least 1 year after completing initial treatment
- Clinically significant Fear of Cancer Recurrence (FCR) defined as Fear of Cancer Recurrence Inventory (FCRI) > 20 at Screening
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- Have an identified support person
- Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
- Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.
Who cannot join
- Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial.
- Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) BP >160/100, HR >110 bpm
- Significant central nervous system (CNS) pathology.
- Primary psychotic or affective psychotic disorders.
- Family history of first-degree relative with psychotic or serious bipolar spectrum illnesses.
- Clinically significant suicidality or high risk of completed suicide.
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- History of hallucinogen persisting perception disorder (HPPD)
- Pregnancy/lactation
- Concurrent Medications
- Psychotherapy
- Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.
- Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Colorado Anschutz Medical Campus (CUAMC)
Aurora, Colorado, 80045
Stacy Fischer, MD
NYU Langone Heath
New York, New York, 10016
Stephen Ross, MD
About this study
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.
- Being tested
- Psilocybin 25 mg, Psilocybin 5 mg
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 25 mgDrug
Experimental dose
Psilocybin 5 mgDrug
Active comparator dose
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin 25mg | Experimental | 1 medication session lasting approximately 8 hours Receives: Drug: Psilocybin 25 mg |
| Psilocybin 5mg | Active comparator | 1 medication session lasting approximately 8 hours Receives: Drug: Psilocybin 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4 Post-Dose Session
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4 Post-Dose Session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start2 Jan 2027 (estimated)
- Primary completion2 Jan 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen Ross, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909408
- Sponsor's protocol ID
- 26-01023
- Other IDs
- 1R01CA312541-01
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin FCR Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT07909408
- Acronym / sponsor ID
- 26-01023
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jan 2027 (estimated)
- Primary completion
- 2 Jan 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin 25mg | Experimental | Drug: Psilocybin 25 mg1 medication session lasting approximately 8 hours |
| Psilocybin 5mg | Active comparator | Drug: Psilocybin 5 mg1 medication session lasting approximately 8 hours |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥ 21
- Females
- Diagnosis of Stage 1 or 2 Estrogen/Progesterone Receptor-Positive (ER/PR +), Human Epidermal growth factor Receptor 2 negative (HER2-) breast cancer
- Having completed initial treatment (e.g. surgery, chemotherapy, radiotherapy) for breast cancer (ongoing adjuvant endocrine, and/or HER2 therapy allowed)
- At least 1 year after completing initial treatment
Key exclusion criteria (12 listed)
- Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial.
- Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) BP >160/100, HR >110 bpm
- Significant central nervous system (CNS) pathology.
- Primary psychotic or affective psychotic disorders.
- Family history of first-degree relative with psychotic or serious bipolar spectrum illnesses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin 25 mgExperimental dose | Drug | Psilocybin 25mg |
| Psilocybin 5 mgActive comparator dose | Drug | Psilocybin 5mg |
Primary outcome
Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)
Time frame: 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.
5 secondary outcomes
Change in Clinical Global Impression-Severity (CGI-S) Score
Time frame: Baseline, Week 4 Post-Dose Session
Clinical Global Impression-Improvement (CGI-S) Score
Time frame: Week 4 Post-Dose Session
Change in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline, Week 4 Post-Dose Session
Change in Functional Assessment of Cancer Therapy-Breast (FACT-B) Score
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
Time frame: Baseline, Week 4 Post-Dose Session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Ross, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin 25 mg and Psilocybin 5 mg in people with Early-stage Breast Cancer and Fear of Cancer Recurrence, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Ross, MD (212-263-6289, Stephen.ross@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) (time frame: Baseline, Week 4 Post-Dose Session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.