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

Trial Summary

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}

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.

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.

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

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

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psilocybin in Palliative Care: An Update. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Medicinal Mushrooms on Gastric, Breast, and Colorectal Cancer: A Scoping Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. [2016]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Immune Modulation From Five Major Mushrooms: Application to Integrative Oncology. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Dose-response relationships of psilocybin-induced subjective experiences in humans. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. [2023]