Actively Recruiting
Psilocybin Therapy in Advanced Cancer
Led by NYU Langone Health · Updated on 2025-12-04
200
Participants Needed
2
Research Sites
188 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Psilocybin Therapy in Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 years or older
- Diagnosis of advanced cancer including stage 3 or 4 solid tumors, metastatic or recurrent illness, or specified late-stage hematologic malignancies
- Functional status with ECOG score 2 or less and Palliative Performance Scale 60% or higher
- Clinically significant anxiety defined as SIGH-A score greater than 17 at screening
- Have an identified support person who agrees to accompany participant home or to a safe destination after dosing
- Participants of childbearing potential must agree to use effective birth control throughout the study
You will not qualify if you...
- Unstable medical conditions or serious abnormalities in blood counts, chemistries, or ECG that could affect safety, including congestive heart failure, significant arrhythmias, recent heart attack, malignant hypertension, long QT syndrome, acute kidney failure, severe liver impairment, or respiratory failure
- Blood pressure over 140/90 mmHg at screening, baseline, or prior to dosing
- Significant central nervous system diseases such as brain tumors, epilepsy, stroke history, cerebral aneurysm, dementia, or delirium
- Primary or affective psychotic disorders including schizophrenia spectrum, schizoaffective disorder, bipolar I with psychotic features, or major depressive disorder with psychotic features
- Family history of psychotic or serious bipolar disorders in first-degree relatives
- High risk of emotional or behavioral adverse reactions such as agitation or violent behavior
- Active substance use disorders (excluding caffeine and nicotine) within the past year
- Extensive serotonergic hallucinogen use including any use in last 12 months or over 25 lifetime uses
- Clinically significant suicidality or high suicide risk based on assessments
- History of hallucinogen persisting perception disorder (HPPD)
- Cognitive impairment with Montreal Cognitive Assessment score below 23
- Use of certain medications including antidepressants, serotonergic agents, antipsychotics, mood stabilizers, aldehyde dehydrogenase inhibitors, significant UGT inhibitors, or niacin supplements (unless suspended during the study)
- Positive urine drug test for various substances unless medically prescribed with stable dose and agreed abstinence for cannabis and psychostimulants
- Psychiatric conditions incompatible with therapy rapport or safe psilocybin exposure
- Pregnant, nursing, or intending pregnancy during the study
- Allergies or intolerance to study drug materials
- Participation in another clinical trial for anxiety, depression, or existential distress interventions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Colorado Anschutz Medical campus (CU AMC)
Aurora, Colorado, United States, 80045
Actively Recruiting
2
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
S
Sydney Weiner, MA
CONTACT
S
Stephen Ross, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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