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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission

Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence (NCT06430541) is a Phase 1 interventional studying Breast Cancer and Ovarian Cancer, sponsored by University of Colorado, Denver. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Breast Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1, Aged ≥ 21 2. Diagnosis of: - early-stage breast cancer at low risk of recurrence - defined as clinical stage 1 or 2 - completed primary treatment (surgery, chemotherapy \[adjuvant, patients may continue to be treated with neoadjuvant\], and/or radiation) \> 6 months ago - oncologist reported risk of recurrence at 10 years \< 20% - late-stage ovarian cancer at high risk of recurrence - defined as Clinical stage 3 or 4 - currently in remission - oncologist reported risk of recurrence at 10 years \> 80% 2. Functional Status defined as: - Eastern Cooperative Oncology Group (ECOG) ≤1 - Palliative Performance Scale (PPS) ≥60% - Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. 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 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study. Who Should NOT Join This Trial: 1. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: - Congestive heart failure - Valvular heart disease - Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e., QTC interval \> 450) - Recent acute myocardial infarction or evidence of ischemia - Malignant hypertension - Congenital long QT syndrome - Acute renal failure - Severe hepatic impairment - Respiratory failure - eGFR \< 50 mL/min/1.73m2 - LFTs \> 1.5 x ULN - WBC \< 5 x 10\*9/L - Hemoglobin \< 8.0 g/dL - Platelets \< 150 x 10\*9/L 2. Risk for hypertensive crisis defined as: Screening and Baseline blood pressure \>140/90 mmHg 3. Significant central nervous system (CNS) pathology Examples include: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1, Aged ≥ 21 2. Diagnosis of: * early-stage breast cancer at low risk of recurrence * defined as clinical stage 1 or 2 * completed primary treatment (surgery, chemotherapy \[adjuvant, patients may continue to be treated with neoadjuvant\], and/or radiation) \> 6 months ago * oncologist reported risk of recurrence at 10 years \< 20% * late-stage ovarian cancer at high risk of recurrence * defined as Clinical stage 3 or 4 * currently in remission * oncologist reported risk of recurrence at 10 years \> 80% 2. Functional Status defined as: * Eastern Cooperative Oncology Group (ECOG) ≤1 * Palliative Performance Scale (PPS) ≥60% * Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. 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 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study. Exclusion Criteria: 1. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: * Congestive heart failure * Valvular heart disease * Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e., QTC interval \> 450) * Recent acute myocardial infarction or evidence of ischemia * Malignant hypertension * Congenital long QT syndrome * Acute renal failure * Severe hepatic impairment * Respiratory failure * eGFR \< 50 mL/min/1.73m2 * LFTs \> 1.5 x ULN * WBC \< 5 x 10\*9/L * Hemoglobin \< 8.0 g/dL * Platelets \< 150 x 10\*9/L 2. Risk for hypertensive crisis defined as: Screening and Baseline blood pressure \>140/90 mmHg 3. Significant central nervous system (CNS) pathology Examples include: * Primary or secondary cerebral neoplasm * Epilepsy * History of stroke * Cerebral aneurysm * Dementia * Delirium 4. Primary psychotic or affective psychotic disorders Examples include current or past DSM-5 criteria for: * Schizophrenia spectrum disorders * Schizoaffective disorder * Bipolar I or bipolar II disorder * Major Depressive Disorder with psychotic features * Prior history of psychosis due to medical condition or substance use 5. Family history of psychotic or serious bipolar spectrum illnesses. Examples include first-degree relative with: * Schizophrenia spectrum disorders * Schizoaffective disorder * Bipolar I disorder with psychotic features 6. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation and judgement. Examples include: * Agitation * Violent behavior 7. Active substance use disorders (SUDs) defined as: * DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year * DAST-10 score of 3 or higher * Two or more "yes" responses to CAGE screening questionnaire 8. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: * Any use in the last 12 months * \>25 lifetime uses 9. Clinically significant suicidality or high risk of completed suicide defined as: * 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline * Any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts * Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior 10. History of hallucinogen persisting perception disorder (HPPD) 11. Pregnancy/lactation 12. Cognitive impairment as defined by: • Montreal Cognitive Assessment Test (MoCA) \< 23 13. Concurrent Medications * Antidepressants * Centrally-acting serotonergic agents (e.g., MAO inhibitors) * Serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort) * Antipsychotics (e.g., first and second generation) * Mood stabilizers (e.g., lithium, valproic acid) * Aldehyde dehydrogenase inhibitors (e.g., disulfiram) * Significant inhibitors of UGT 1A0 or UGT 1A10 * Efavirenz 14. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone) unless prescribed, and Phencyclidine (PCP). 15. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin 16. Have any psychological or physical symptom, medication, or other relevant finding , based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study. 17. Have an allergy or intolerance to any of the materials contained in the drug product 18. Non-English speaking individual 19. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)

Treatments Being Tested

DRUG

Psilocybin

A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Outpatient CTRC
Aurora, Colorado, United States
University of Colorado Cancer Center
Aurora, Colorado, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06430541), the sponsor (University of Colorado, Denver), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06430541 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06430541?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06430541?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06430541. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06430541. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.