Psilocybin Assisted Psychotherapy for Cancer Recurrence

Recruiting at 1 trial location

Overseen By Mary Mancuso

Age: 18+

Sex: Female

Trial Phase: Phase 1

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 All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether psilocybin, a psychedelic compound, combined with therapy can reduce the fear of cancer recurrence in women who have had early-stage breast cancer or late-stage ovarian cancer. The study also examines whether this treatment can alleviate anxiety, depression, and improve overall quality of life. Participants will engage in therapy sessions, receive a dose of psilocybin in a safe setting, and continue with follow-up therapy. Women who have completed treatment for early breast cancer or are in remission from late-stage ovarian cancer and are concerned about cancer returning might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

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.

Is there any evidence suggesting that psilocybin assisted therapy is likely to be safe for humans?

Research has shown that psilocybin, when used in a controlled environment, is generally safe. In one study, participants who took a single 25 mg dose experienced no serious side effects. Another study examined its use for feelings of demoralization and also found no major safety issues. However, short-term side effects, such as mood or perception changes, can occur. Information on long-term safety is still being collected, making ongoing research important. This trial is in its early stages and primarily aims to assess safety and gather initial feedback. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Psilocybin Assisted Psychotherapy is unique because it combines a psychedelic compound, psilocybin, with therapy to potentially ease the psychological distress associated with cancer recurrence. Unlike traditional treatments like antidepressants or psychotherapy alone, psilocybin may induce profound emotional and cognitive effects in a single session, potentially leading to quicker relief from anxiety and depression. Researchers are excited about psilocybin's ability to target serotonin receptors in the brain, offering a novel mechanism of action that could complement or even improve upon existing therapies.

What evidence suggests that psilocybin assisted therapy might be an effective treatment for fear of cancer recurrence?

Research has shown that psilocybin-assisted therapy can improve mental health. One study found that a single 25 mg dose of psilocybin significantly reduced depression symptoms for three weeks. Another study suggested that this dose might help maintain antidepressant effects for up to a year. Psilocybin has also shown promise in improving quality of life and reducing anxiety in patients with advanced cancer. In this trial, participants will receive psilocybin-assisted psychotherapy, which may help with fear of cancer returning, anxiety, and depression. ^{1 6 7 8 9}

Who Is on the Research Team?

Stacy Fischer, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

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

I am worried my cancer will come back.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The 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.

How Is the Trial Designed?

Group I: Psilocybin Assisted Psychotherapy Experimental Treatment 1 Intervention

25mg cGMP Psilocybin in combination with manualized therapy

Psilocybin is already approved in United States, European Union for the following indications:

Approved in United States as Psilocybin for:

• Treatment-resistant depression (TRD) under Breakthrough Therapy designation

Approved in European Union as Psilocybin for:

• Treatment-resistant depression (TRD) under PRIME designation

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Usona Institute

Collaborator

Trials

18

Recruited

1,100+

Published Research Related to This Trial

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A meta-analysis of psilocybin studies found that higher doses of psilocybin are associated with stronger subjective experiences, particularly in areas like perceptual alterations and ego dissolution, based on data from standardized questionnaires.

Challenging experiences were less affected by dose, suggesting that individual and environmental factors also play a significant role in the psilocybin experience, indicating that these findings are most relevant in controlled settings rather than recreational use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Psilocybin-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.

The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A 30-year-old man experienced severe symptoms, including vomiting and muscle pain, after receiving an intravenous injection of Psilocybe mushroom extract, highlighting the potential dangers of using hallucinogenic substances in non-traditional ways.

The patient showed rapid improvement with supportive care, suggesting that while the effects of Psilocybe mushrooms can be serious, timely medical intervention can effectively manage the symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Medicinal mushrooms like Shiitake, Turkey Tail, and Scaly Wood show promise in cancer treatment by potentially preventing lymph node metastasis, prolonging survival, and reducing side effects from chemotherapy, based on a review of nine studies.

The review highlights the need for more rigorous research, including randomized controlled trials with larger sample sizes, to confirm these benefits and determine the most effective dosages for patients with high-mortality cancers such as gastric, breast, and colorectal cancer.

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]

A long-term follow-up of 15 participants from a previous trial showed that psilocybin-assisted psychotherapy led to sustained reductions in anxiety, depression, and other distressing symptoms, with 60-80% of participants still experiencing significant improvements 3.2 to 4.5 years later.

Participants reported that the psilocybin therapy was among the most meaningful experiences of their lives, indicating its potential to enhance psychological and spiritual well-being in patients facing life-threatening cancer.

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]

In a study involving 12 healthy adults, escalating doses of psilocybin (0.3, 0.45, and 0.6 mg/kg) were administered safely, with no serious adverse events reported, indicating a favorable safety profile for this psychedelic compound.

The pharmacokinetics of psilocin, the active metabolite of psilocybin, were linear across the tested doses, with an elimination half-life of about 3 hours, suggesting that no dose adjustments are necessary for individuals with mild to moderate renal impairment.

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]

The review highlights that five major mushrooms—Agaricus blazei, Cordyceps sinensis, Grifola frondosa, Ganoderma lucidum, and Trametes versicolor—can modify cytokine levels in cancer models, potentially influencing the disease process and immune response.

In addition to their immunological roles, these mushrooms may enhance the efficacy of chemotherapy and mitigate myelosuppression, with promising preliminary research suggesting their potential as adjunct treatments in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

The HOPE trial, involving 12 cancer patients, showed that psilocybin-assisted group therapy is safe, with no serious adverse events reported, and resulted in significant reductions in depression symptoms over six months.

Participants experienced substantial decreases in depression scores, with six out of twelve achieving remission at two weeks, indicating that this group therapy model could be an effective treatment for depression in cancer patients.

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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206443

Single-Dose Psilocybin for a Treatment-Resistant Episode ... Psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40047545/

Results From a Long-Term Observational Follow-Up Study ... Over 52 weeks, a single administration of 25 mg psilocybin suggested longer maintenance of antidepressant effect than both 1 mg and 10 mg.

3. sciencedirect.com sciencedirect.com/science/article/pii/S016503272300126X

Single-dose psilocybin for a treatment-resistant episode of ... At Week 3, psilocybin 25 mg, compared with 1 mg, was associated with greater improvements from Baseline total scores in all measures. The 10 mg ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11271737/

Investigating the therapeutic efficacy of psilocybin in advanced ... Psilocybin-assisted therapy shows promising results in improving quality of life, pain control, and anxiety relief for patients with advanced cancer.

5. biospace.com biospace.com/press-releases/compass-pathways-announces-publication-of-results-from-comp004-study-on-comp360-psilocybin-for-treatment-resistant-depression

Compass Pathways Announces Publication of Results from ... The COMP004 study's findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/08/NCT04950608/Prot_SAP_000.pdf

Pilot study of Psilocybin-Assisted Therapy for demoralization in ... Data Safety Monitoring ... To explore the safety of psilocybin-assisted therapy in this population and its preliminary ... Safety outcomes: • Changes in vital signs ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12030455/

The Emergence of Psilocybin in Psychiatry and Neuroscience While short-term adverse effects are frequently observed, long-term safety data remain limited, emphasizing the need for additional well-powered trials to ...

8. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00450-X/fulltext

Considerations and cautions for the integration of ... Investment in carefully collected phenotypic data in patients undergoing psychedelic therapy, both to identify predictors of therapeutic response and predictors ...

9. ir.compasspathways.com ir.compasspathways.com/News--Events-/news/news-details/2025/Compass-Pathways-Announces-Publication-of-Results-from-Phase-2-Study-of-COMP360-Psilocybin-for-Post-Traumatic-Stress-Disorder/default.aspx

News Details Open-label Phase 2 study shows a single 25 mg COMP360 psilocybin dose was well tolerated, with no serious adverse events observed, ...