Psilocybin Therapy for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Stephen Ross, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: NYU Langone Health

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

Disqualifiers: Congestive heart failure, Epilepsy, Schizophrenia, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.

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.

What data supports the effectiveness of this drug for advanced cancer?

Research shows that psilocybin-assisted psychotherapy can improve psychiatric distress, quality of life, and spiritual well-being in cancer patients, with 60-80% maintaining significant antidepressant or anxiety relief for months after treatment. ^{1 2 3 4 5}

Is psilocybin therapy generally safe for humans?

Psilocybin, found in magic mushrooms, can cause challenging experiences, but when used in controlled settings with support, the risk of lasting psychological distress or risky behavior is very low. Some studies suggest that psilocybin does not worsen certain heart conditions and may even protect against cell injury, but caution is advised with higher doses. ^{1 6 7 8 9}

How is psilocybin therapy different from other treatments for advanced cancer?

Psilocybin therapy is unique because it uses a psychedelic compound found in certain mushrooms to potentially improve mental well-being and reduce anxiety in patients with advanced cancer, unlike traditional treatments that focus primarily on physical symptoms. It is not yet approved for therapeutic use in the U.S., but it has shown promise in palliative care by providing long-term improvements in mood and quality of life with minimal side effects. ^{1 2 4 5 10}

Research Team

Stephen Ross, MD

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Niacin 100mg (Other)
• Psilocybin (Psychedelic)
• Psychotherapy (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Colorado Anschutz Medical campus (CU AMC) Aurora, CO

NYU Langone Health New York, NY

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1431

Patients Recruited

838,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. Curry, SC., Rose, MC.[2019]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

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]

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]

References

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

The pharmacology of psilocybin. [2016]

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

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

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

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

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

Psilocybin in Palliative Care: An Update. [2023]

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

Intravenous mushroom poisoning. [2019]

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

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. [2018]

9. England 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. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]