Psilocybin Group Therapy for Cancer-Related Anxiety

Overseen By Anthony L. Back, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Washington

Must not be taking: MAOIs, Tramadol, Efavirenz, others

Disqualifiers: Brain metastases, Pregnancy, Schizophrenia, 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

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a second round of psilocybin-assisted group therapy can safely and effectively reduce anxiety and distress in people with metastatic cancer. Psilocybin, found in "magic mushrooms," may alter brain function related to mood, potentially easing anxiety. Group therapy aims to enhance well-being and quality of life. The trial seeks participants with metastatic cancer who experience significant anxiety or distress. Participants should have previously experienced partial relief from similar therapy sessions but still face anxiety issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

You may need to stop certain medications for this trial. You can continue taking SSRIs (a type of antidepressant), but you must avoid starting new psychiatric medications. If you are using medications like tramadol, MAOIs, or serotonin-acting supplements, you will need to stop them due to potential interactions with psilocybin.

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

Research has shown that psilocybin, the active ingredient in "magic mushrooms," might be safe for people with cancer-related anxiety. Studies have found that psilocybin therapy can improve quality of life and reduce anxiety and depression in cancer patients. For example, one study found that a single dose of psilocybin significantly lowered anxiety and boosted mood. Another study reported that patients continued to feel less anxious after treatment.

Some side effects, such as temporary changes in mood or perception, can occur, but they are usually mild and manageable with medical supervision. Overall, psilocybin-assisted therapy appears promising for improving the emotional well-being of people with cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer-related anxiety, which often include medications like antidepressants and benzodiazepines, psilocybin offers a unique approach by acting on serotonin receptors in the brain. This psychedelic compound has the potential to bring about profound changes in perception and mood, offering relief from anxiety in a way that traditional treatments may not. Researchers are excited about psilocybin because it can provide rapid and lasting effects with just one or a few doses, whereas conventional medications often require continuous use. Additionally, the integration of group therapy with psilocybin might enhance its therapeutic effects, fostering a sense of community and shared experience among patients.

What evidence suggests that psilocybin-assisted group therapy might be an effective treatment for cancer-related anxiety?

Research shows that psilocybin, a substance in "magic mushrooms," might help reduce anxiety and distress in cancer patients. Psilocybin affects certain parts of the brain, leading to changes in mood and perception. Studies have found that it can cause strong mood shifts that might lower anxiety. In this trial, participants will receive psilocybin as part of group therapy sessions. Earlier research has shown that therapy using psilocybin has promise in boosting emotional well-being and quality of life for people with serious illnesses. While more research is needed, these early findings suggest psilocybin could help manage anxiety in patients with advanced cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Anthony L. Back, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for patients with metastatic cancer who have experienced only partial relief from anxiety after their first therapy session. Participants should be dealing with significant anxiety related to their cancer diagnosis and treatment.

Inclusion Criteria

Participation in BACK002 with specific outcome measures

Willingness to use effective contraceptive method

I have undergone chemotherapy before.

Exclusion Criteria

I am taking medication that affects my heart's electrical cycle.

Current substance abuse disorder

My medical or neurological condition is stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Participants attend group preparation visits and an individual prep visit

2 weeks

3 group visits (in-person), 1 individual visit (in-person)

Treatment

Participants receive psilocybin with an optional booster dose and attend integration visits

5 weeks

1 treatment visit (in-person), 4 integration visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Follow-up visits at 2, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study is testing the safety and effectiveness of a second psilocybin-assisted group therapy session in reducing anxiety for those with metastatic cancer. Psilocybin, derived from 'magic mushrooms', may help by altering mood and thought patterns.

How Is the Trial Designed?

Group I: Treatment (psilocybin, group therapy) Experimental Treatment 4 Interventions

Patients receive psilocybin PO with optional booster dose on day 0. Patients attend an individual prep visit on day -1 and an individual integration visit on day 1. Patients also attend group preparation visits on days -14, -7 and -1 and group integration visits on days 1, 8, 22 and 36.

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 Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Steven & Alexandra Cohen Foundation

Collaborator

Trials

10

Recruited

320+

Published Research Related to This Trial

In a study involving 18 older long-term AIDS survivor men, psilocybin-assisted group therapy was found to be feasible and relatively safe, with no serious adverse reactions reported and only mild expected side effects experienced by some participants.

Participants showed a significant reduction in demoralization levels from baseline to a 3-month follow-up, indicating potential efficacy for psilocybin therapy in addressing psychological distress in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. Anderson, BT., Danforth, A., Daroff, PR., 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]

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 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]

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]

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 examining the effects of Psilocybe cubensis and Panaeolus cyanescens mushrooms on heart cells, the extracts did not worsen hypertrophy caused by endothelin-1 and provided protection against TNF-α-induced cell injury.

The findings suggest that these mushroom extracts can be safely used in controlled conditions for potential therapeutic benefits in heart disease, although caution is advised with higher concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. Nkadimeng, SM., Steinmann, CML., Eloff, JN.[2021]

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 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. en.wikipedia.org en.wikipedia.org/wiki/Psilocybin

Psilocybin Psilocybin, also known as 4-phosphoryloxy-N,N-dimethyltryptamine (4-PO-DMT), is a naturally occurring tryptamine alkaloid and investigational drug found in ...

2. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Psilocybin

Psilocybin | C12H17N2O4P | CID 10624 - PubChem - NIH Psilocybin is a tryptamine alkaloid that is N,N-dimethyltryptamine carrying an additional phosphoryloxy substituent at position 4.

3. en.wikipedia.org en.wikipedia.org/wiki/Psilocin

Psilocin Psilocin, also known as 4-hydroxy-N,N-dimethyltryptamine (4-HO-DMT), is a substituted tryptamine alkaloid and a serotonergic psychedelic.

4. webbook.nist.gov webbook.nist.gov/cgi/cbook.cgi?ID=520-52-5

Psilocybine - the NIST WebBook Psilocybine. Formula: C12H17N2O4P ... 4-Phosphoryloxy-N,N-dimethyltryptamine; Psilocibin; Psilocin phosphate ester; Psilotsibin; Teonanacatl; Psylocybin ...

5. zfin.org zfin.org/CHEBI:8614

ZFIN ChEBI: psilocybin A tryptamine alkaloid that is N,N-dimethyltryptamine carrying an additional phosphoryloxy substituent at position 4. The major hallucinogenic alkaloid isolated ...

6. 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.

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

Assessment of Psilocybin Therapy for Patients With Cancer ... Outcome measures included safety and improvement in depression, which was primarily measured with the Montgomery-Asberg Depression Rating Scale ...

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

Single-dose psilocybin for a treatment-resistant episode of ... The treatment reduced anxiety and increased positive affect while reducing negative affect. Psilocybin was also rapid-acting, with treatment ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07216404?term=NA

Psilocybin-Assisted Therapy for the Treatment of Major ... Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung ...

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

Single-Dose Psilocybin for a Treatment-Resistant Episode ... Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: a randomized double- ...