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~13 spots leftby Dec 2026

Psilocybin Assisted Psychotherapy for Cancer Recurrence

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byStacy Fischer, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of Colorado, Denver

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, others

Disqualifiers: Unstable medical conditions, CNS pathology, Psychotic disorders, Substance use, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, including antidepressants, centrally-acting serotonergic agents, serotonin-acting dietary supplements, antipsychotics, mood stabilizers, aldehyde dehydrogenase inhibitors, significant inhibitors of UGT 1A0 or UGT 1A10, and efavirenz. If you are on any of these medications, you may need to stop them to participate in the trial.

What evidence supports the effectiveness of the drug psilocybin in treating cancer recurrence?

Psilocybin-assisted psychotherapy has shown promise in treating depression and existential distress in cancer patients, as seen in the HOPE pilot study. Additionally, psilocybin is being explored for its potential benefits in palliative care, although it is not yet approved for therapeutic use in the United States.¹ ² ³ ⁴ ⁵

Is psilocybin generally safe for humans?

Psilocybin has been studied in healthy adults with escalating doses, showing a safety profile that is generally well-tolerated, although it can cause hallucinations and other effects on the central nervous system. Supportive care can help manage symptoms if adverse effects occur.² ⁴ ⁵ ⁶ ⁷

How is the drug psilocybin unique in treating cancer recurrence?

Psilocybin is unique because it is a psychoactive compound from 'magic mushrooms' that, when used with psychotherapy, can improve psychiatric and existential distress, quality of life, and spiritual well-being in cancer patients, unlike traditional cancer treatments that focus primarily on physical symptoms.² ⁴ ⁸ ⁹ ¹⁰

Research Team

Stacy Fischer, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for women who have had early breast or ovarian cancer and are now in remission but are struggling with the fear that their cancer will come back. They should be open to therapy sessions and taking psilocybin under supervision.

Inclusion Criteria

My early-stage breast cancer has a low risk of coming back, as per my oncologist.

I am worried my cancer will come back.

Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.

See 4 more

Exclusion Criteria

Cognitive impairment as defined by Montreal Cognitive Assessment Test (MoCA) < 23

Allergy or intolerance to any of the materials contained in the drug product

Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that would preclude safe participation in the trial

See 16 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Therapy

Participants complete a series of survey measures and participate in preparatory therapy sessions

4 weeks

Multiple sessions (in-person)

Psilocybin Dosing

Participants receive a moderately high dose of psilocybin in a monitored and supportive environment

1 day

1 visit (in-person)

Integrative Therapy

Participants complete 4 sessions of integrative therapy and complete survey measures

4 weeks

4 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Regular assessments at 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks

Treatment Details

Interventions

Psilocybin (Psychedelic Therapy)

Trial OverviewThe study is testing if therapy combined with a moderate dose of psilocybin can reduce the fear of cancer coming back, as well as improve anxiety, depression, and overall quality of life in these women.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Psilocybin Assisted PsychotherapyExperimental Treatment1 Intervention

25mg cGMP Psilocybin in combination with manualized therapy

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Outpatient CTRCAurora, CO

University of Colorado Cancer CenterAurora, CO

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Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1842

Patients Recruited

3,028,000+

Usona Institute

Collaborator

Trials

Patients Recruited

1,100+

Findings from Research

Psilocybin shows promising effects in alleviating anxiety, depression, and emotional distress in palliative care patients, with a favorable safety profile, based on recent studies and reports.

Despite its potential benefits, psilocybin is not yet approved for therapeutic use in the U.S., and significant barriers exist for access, particularly for vulnerable populations like the elderly and those in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin in Palliative Care: An Update.Whinkin, E., Opalka, M., Watters, C., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Medicinal Mushrooms on Gastric, Breast, and Colorectal Cancer: A Scoping Review.Dan, A., Swain, R., Belonce, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer.Lewis, BR., Garland, EL., Byrne, K., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin.Passie, T., Seifert, J., Schneider, U., et al.[2016]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms].Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults.Brown, RT., Nicholas, CR., Cozzi, NV., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning.Curry, SC., Rose, MC.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune Modulation From Five Major Mushrooms: Application to Integrative Oncology.Guggenheim, AG., Wright, KM., Zwickey, HL.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response relationships of psilocybin-induced subjective experiences in humans.Hirschfeld, T., Schmidt, TT.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer.Agin-Liebes, GI., Malone, T., Yalch, MM., et al.[2023]