Psilocybin With Psychotherapy for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Must be taking: Opioids

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

Disqualifiers: Pregnancy, Cognitive impairment, Heart disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications that interact with the study drug, such as antidepressants and some mood stabilizers. If you are on these medications, you might need to taper off them before starting the trial. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug psilocybin with psychotherapy for cancer?

Research shows that psilocybin-assisted psychotherapy can significantly reduce depression and anxiety in cancer patients, with improvements in mood, quality of life, and spiritual well-being lasting up to six months. In several studies, 60-80% of participants experienced clinically significant improvements in these areas. ^{1 2 3 4 5}

Is psilocybin safe for use in cancer patients?

Research shows that psilocybin, when used with psychotherapy, is generally safe for cancer patients, with studies reporting sustained improvements in mood and anxiety without significant safety concerns. ^{1 2 3 5 6}

How is the drug psilocybin unique in treating cancer-related distress?

Psilocybin, a compound from certain mushrooms, is unique because it is used with psychotherapy to help cancer patients with depression and existential distress by inducing altered states of consciousness, which can lead to improved mental health and spiritual well-being. Unlike traditional treatments, it shows promise for those with treatment-resistant mental health issues and can provide long-lasting benefits after just one or a few doses. ^{1 3 5 7 8}

What is the purpose of this trial?

This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). This may impact a patient's "total pain", a view that accounts for the psychological, spiritual, and social factors that contribute to their experience of pain. Psychotherapy uses methods such as discussion, listening, and counseling to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving psilocybin with psychotherapy may be safe and helpful for improving chronic pain in cancer patients who require opioids to manage their pain.

Research Team

William Alexander

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for cancer patients experiencing chronic pain and using opioids for pain management. Participants should be interested in a combination of psilocybin (a compound from mushrooms that causes hallucinations) and psychotherapy to address their 'total pain', which includes psychological, spiritual, and social factors.

Inclusion Criteria

Estimated prognosis of at least 3 months at the time of enrollment, determined by participant's primary oncologist or palliative physician

Participants must be able to swallow pills

No known procedures/treatments scheduled that would prohibit or significantly delay completion of the study

Exclusion Criteria

Contraindications to undergoing an fMRI scan

Hypersensitivity to specific ingredients of the Investigational Medicinal Product (IMP)

I am on medication that can't be stopped or changed for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Psychotherapy

Participants attend two preparatory psychotherapy sessions

1 week

2 visits (in-person)

Treatment

Participants receive psilocybin orally twice a week for 4 weeks, with integration psychotherapy sessions during dosing sessions 2, 4, and 6

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with optional additional psychotherapy sessions

8 weeks

3 visits (in-person)

Treatment Details

Interventions

• Psilocybin

Trial Overview The study is testing the safety and effectiveness of psilocybin combined with psychotherapy to improve chronic pain in cancer patients on opioids. It involves taking psilocybin, undergoing therapy sessions, interviews, questionnaires, biospecimen collection, and brain imaging through fMRI.

Participant Groups

Group I: Supportive care (psychotherapy, psilocybin) Experimental Treatment 6 Interventions

Patients attend two preparatory psychotherapy sessions. Patients then receive psilocybin PO BIW for 4 weeks (8 doses total) in the absence of unacceptable toxicity and attend three integration psychotherapy sessions over 1.5 hours each during psilocybin dosing sessions 2, 4, and 6. Patients may optionally attend additional psychotherapy sessions as needed during follow-up. Additionally, patients undergo fMRI and collection of blood and urine samples throughout the study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Findings from Research

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 double-blind, placebo-controlled trial with 29 cancer patients, a single dose of psilocybin (0.3 mg/kg) combined with psychotherapy led to significant and lasting reductions in anxiety and depression, with 60-80% of participants showing sustained improvements at a 6.5-month follow-up.

The positive effects of psilocybin were linked to the mystical experiences it induced, which helped improve patients' quality of life, reduce existential distress, and foster better attitudes towards death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. Ross, S., Bossis, A., Guss, J., et al.[2022]

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 has shown significant therapeutic effects in reducing symptoms of depression and anxiety in patients with life-threatening diseases, based on a systematic review and meta-analysis of clinical trials involving 92 patients.

The results indicate that psilocybin may be a safe and effective treatment option, particularly for cases resistant to conventional therapies, with significant improvements measured by the Beck Depression Inventory and State-Trait Anxiety Inventory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials. Vargas, AS., Luís, Â., Barroso, M., et al.[2020]

References

1. 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]

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

Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. [2018]

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

Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Individual Experiences in Four Cancer Patients Following Psilocybin-Assisted Psychotherapy. [2020]

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

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

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

Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials. [2020]

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

The Role of Psilocybin-Assisted Psychotherapy to Support Patients With Cancer: A Critical Scoping Review of the Research. [2022]

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

Psychedelics for Patients With Cancer: A Comprehensive Literature Review. [2023]