Psilocybin Therapy for Advanced Cancer

Recruiting at 1 trial location

Overseen By Sydney Weiner, MA

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: NYU Langone Health

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

Disqualifiers: Congestive heart failure, Epilepsy, Schizophrenia, 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

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a single dose of psilocybin, combined with brief therapy, can reduce anxiety, depression, and hopelessness in people with advanced cancer. Researchers compare psilocybin to niacin, a vitamin used as a placebo, to determine which is more effective. The trial suits those with stage 3 or 4 cancer experiencing significant anxiety and who have a support person available after the treatment session. Participants will receive either psilocybin or niacin along with supportive therapy. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer care advancements.

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

Yes, you may need to stop certain medications to join the trial. You cannot take antidepressants, certain mood stabilizers, antipsychotics, or centrally-acting serotonergic agents. If you are taking niacin, you must stop at least five days before the trial. However, prescribed opiates and benzodiazepines can continue if you've been on a stable dose for a specified period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that psilocybin is generally safe for people with cancer. In studies, patients who took just one dose of psilocybin experienced no serious side effects. Most had mild or moderate reactions, such as nausea, headaches, or temporary anxiety, which typically resolved on their own.

One study found that psilocybin is safe for treating anxiety and depression in cancer patients. This research identified no major safety issues with psilocybin therapy. These findings suggest that psilocybin, when used in a controlled setting with professional support, is well-tolerated by patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for advanced cancer?

Unlike the standard treatments for advanced cancer, which often focus on chemotherapy, radiation, or targeted therapies, psilocybin-assisted psychotherapy (PAP) offers a unique approach by combining a psychedelic compound, psilocybin, with psychotherapy. Researchers are excited about psilocybin because it works on the brain's serotonin receptors in a way that can potentially help alleviate the psychological distress and anxiety often associated with advanced cancer. This approach aims to improve the quality of life and mental well-being of patients, offering benefits that traditional methods might not provide. Additionally, the rapid onset of psilocybin's effects means patients could experience relief in a significantly shorter time frame compared to many conventional treatments.

What evidence suggests that psilocybin-assisted psychotherapy could be effective for anxiety, depression, and existential distress in advanced cancer?

Research has shown that therapy using psilocybin, a compound in certain mushrooms, can improve quality of life and reduce anxiety for patients with advanced cancer. In this trial, participants in one arm will receive psilocybin-assisted psychotherapy, which combines psilocybin with a manualized psychotherapy platform. Studies have found that this treatment can also alleviate depression and distress, providing a sense of meaning and reducing fear of death. Specifically, one study found that psilocybin, when used with therapy, improved depression symptoms in cancer patients. Another small study observed that a single dose could help relieve anxiety in those with advanced cancer. These findings suggest that psilocybin therapy may offer promising emotional support in advanced cancer care. ^{2 4 6 7 8}

Who Is on the Research Team?

Stephen Ross, MD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

Adults aged 21+ with advanced stage 3 or 4 cancer experiencing significant depression, anxiety, or existential distress. They must have a support person and agree to use birth control if of childbearing potential. Excluded are those with certain psychiatric disorders, severe heart conditions, epilepsy, dementia, high suicide risk, drug abuse history within the past year, and those on conflicting medications.

Inclusion Criteria

Clinically significant Anxiety defined as SIGH-A >17 at Screening

I agree to use effective birth control during the study.

I am experiencing significant depression or anxiety, or I feel a deep sense of hopelessness.

Exclusion Criteria

I have respiratory failure.

I have a serious brain or spinal cord condition.

I have a brain tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of psilocybin (25mg) or niacin (100mg) along with psychotherapy to treat anxiety, depression, and existential distress

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual) at various intervals

What Are the Treatments Tested in This Trial?

Interventions

• Niacin 100mg
• Psilocybin
• Psychotherapy

Trial Overview The trial is testing the effects of a single dose of psilocybin (25mg) versus an active placebo (niacin 100mg) in reducing anxiety and depression associated with advanced cancer. This is paired with brief psychotherapy aimed at addressing emotional distress related to their condition.

How Is the Trial Designed?

Group I: Participants receiving Study Drug Experimental Treatment 2 Interventions

Advanced cancer participants will receive experimental medication, psilocybin (25mg). In addition to the pharmacologic intervention, participants will receive a manualized psychotherapy platform. The combination of interventions is referred to as psilocybin-assisted psychotherapy (PAP).

Group II: Participants receiving Placebo Active Control 2 Interventions

Advanced cancer participants will receive active placebo - single dose of niacin (100mg). In addition to the placebo, participants will receive the same manualized psychotherapy platform as the experimental arm.

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?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

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]

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]

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]

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]

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]

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

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]

In a survey of 1993 individuals who experienced challenging psilocybin trips, 39% rated their experience as one of the most difficult of their lives, with 11% reporting risks of physical harm, particularly influenced by dose and lack of support.

Despite the challenges, 84% of respondents felt they benefited from the experience, suggesting that while adverse effects can occur, the overall incidence of serious psychological distress is low, especially in controlled settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. Carbonaro, TM., Bradstreet, MP., Barrett, FS., et al.[2018]

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]

Citations

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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 using a ...

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Study Details | NCT05506982 | Psilocybin Combined With ... This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with ...

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Single-dose psilocybin for a treatment-resistant episode of ... Psilocybin 25 mg improved SDS total score at Week 3, reduced the number of lost and unproductive days by Week 3, and improved function as ...

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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 ...