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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if psilocybin, a compound from certain mushrooms, combined with therapy, can safely reduce chronic pain in cancer patients who require opioids. Psilocybin may alter patients' pain experiences by considering mental and social factors. Individuals with active cancer who have experienced moderate to severe pain for at least three months and are currently using opioids may be suitable for this study. The trial involves taking psilocybin pills and attending therapy sessions over several weeks. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

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.

Is there any evidence suggesting that psilocybin with psychotherapy is likely to be safe for cancer patients?

Research has shown that psilocybin, when used in a controlled environment, is generally safe for people with cancer. Studies have found that it can help reduce depression and anxiety in cancer patients. For instance, one study administered psilocybin to 51 cancer patients, resulting in positive effects on their mental health.

Safety data indicates that psilocybin is well-tolerated, although some individuals might experience temporary side effects, such as changes in mood or perception, which do not last long. Specifically, a study tested psilocybin on patients with cancer and depression, finding it safe and effective.

Overall, research suggests that psilocybin is safe for use in cancer patients, especially under professional supervision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer-related distress, which typically involve medications like antidepressants or anti-anxiety drugs, psilocybin offers a unique approach. Psilocybin is derived from psychedelic mushrooms and works by affecting serotonin receptors in the brain, potentially leading to profound changes in mood and perception. Researchers are excited about psilocybin because it is paired with psychotherapy to enhance its effects, and it has shown promise in providing rapid and lasting relief from psychological distress in cancer patients. Unlike conventional treatments that may take weeks to show benefits, psilocybin could offer quicker improvements in emotional well-being.

What evidence suggests that psilocybin with psychotherapy might be an effective treatment for chronic pain in cancer patients?

Research shows that psilocybin, when combined with therapy, can reduce depression and anxiety in cancer patients. In this trial, participants will receive psilocybin alongside psychotherapy. Previous studies with these patients have demonstrated that psilocybin therapy significantly improves quality of life and pain management. These benefits persisted over time, indicating long-term positive effects. Psilocybin therapy also eases deep anxiety about the meaning of life, known as existential distress. Overall, psilocybin-assisted therapy appears promising for enhancing emotional well-being and managing pain in people with cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

William Alexander

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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

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

Participants must be able to swallow pills

Exclusion Criteria

Contraindications to undergoing an fMRI scan

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

Recent use of serotonergic hallucinogens

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5367557/

Psilocybin produces substantial and sustained decreases ... Previous studies suggest that psilocybin may decrease depression and anxiety in cancer patients. The effects of psilocybin were studied in 51 cancer patients ...

2. hopkinsmedicine.org hopkinsmedicine.org/psychiatry/research/psychedelics-research

Psychedelics Research and Psilocybin Therapy 2016 (Document) : Psilocybin eases existential anxiety in people with life threatening cancer. In a small double-blind study, Johns Hopkins researchers ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40259688/

Evaluating the effectiveness of psilocybin in alleviating ... Psilocybin therapy consistently showed significant reductions in depression, anxiety, and existential distress, with improvements sustained over ...

4. wjgnet.com wjgnet.com/2218-4333/full/v15/i7/908.htm

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

5. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R01CA268521

Funded Grants | Division of Cancer Prevention Based on extensive preliminary data, psilocybin-assisted therapy has demonstrated both safety and preliminary efficacy to improve cancer-related depression and ...

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2803623

Assessment of Psilocybin Therapy for Patients With Cancer ... Nonetheless, this study demonstrates the safety and preliminary efficacy of psilocybin treatment for patients with cancer and depression ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S277240852400125X

Safety pharmacology of acute psilocybin administration in ... The results of this study indicate that psilocybin appears to be safe in a controlled setting with transient adverse effects. The safety data can partially be ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.12097

The safety and efficacy of psilocybin therapy in patients ... This trial built upon previous studies and tested the safety, feasibility, and efficacy of psilocybin therapy in cancer patients diagnosed with major ...