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Psychedelic

Psilocybin Therapy for Advanced Cancer

Phase 2 & 3

Recruiting

Led By Stephen Ross, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged ≥ 21

Diagnosis of Advanced (i.e. stage 3 or 4 solid tumors) Cancer

Must not have

- Congestive heart failure

- Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval > 450)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8, month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and effects of psilocybin in treating anxiety, depression, and existential distress in advanced cancer patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include temporary changes in perception and mood swings during treatment. Niacin may cause flushing or mild dizziness. Long-term psychological effects are unknown but could potentially include persistent altered states of perception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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My cancer is at an advanced stage (3 or 4).

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I can care for myself and do up to some work despite my illness.

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I am 21 years old or older.

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My cancer is advanced or has come back.

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I have an advanced blood cancer such as late-stage lymphoma, myeloma, or leukemia.

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I can care for myself and do light activities.

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I have someone to take me home after my treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have congestive heart failure.

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I do not have serious heart rhythm problems or abnormal ECG results.

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I have recently had a heart attack or signs of poor blood flow to my heart.

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I have been diagnosed with severe, uncontrolled high blood pressure.

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I have a condition that affects my heart's rhythm.

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I am currently experiencing sudden kidney failure.

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I have severe liver problems.

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I have respiratory failure.

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I have a serious brain or spinal cord condition.

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I have a brain tumor.

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I have epilepsy.

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I have had a stroke in the past.

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I have a cerebral aneurysm.

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I have not experienced episodes of severe confusion (delirium).

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I have been diagnosed with Bipolar I disorder and experience psychosis.

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I have been diagnosed with major depression that includes psychosis.

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I have been diagnosed with Bipolar I disorder with psychotic features.

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I experience frequent agitation.

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I am not taking any medications that significantly affect serotonin levels in my brain.

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I am taking antipsychotic medication.

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I am not taking any aldehyde dehydrogenase inhibitors.

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I am not taking any strong inhibitors of UGT 1A0 or UGT 1A10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A Score

Secondary study objectives

Change in Clinical Global Impression - Improvement (CGI-I) Score

Change in Clinical Global Impression - Severity of Illness (CGI-S) Score

Change in Death Transcendence Scale (DTS) Score

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Participants receiving Study DrugExperimental Treatment2 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 PlaceboActive Control2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psychotherapy

2014

Completed Phase 3

~3440

0 / 30Eligibility criteria met