Psilocybin Therapy in Advanced Cancer

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT05398484

Run by

NYU Langone Health

People needed

200

Starts

2023-05-24

Expected to finish

2027-01-01

Last updated by the study team

2025-12-04

Who can join

Age: 21 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 21
• Diagnosis of Advanced Cancer defined as:
• Solid tumors to include stage 3 or 4, metastatic illness, or recurrent illness
• Hematologic malignancies to include, but not limited to, Stage 3 or 4 non-Hodgkins lymphoma, late-stage multiple myeloma or second-line therapy for multiple myeloma, and all forms of acute myeloid leukemia
• Functional Status defined as: Eastern Cooperative Oncology Group (ECOG) ≤2 and Palliative Performance Scale (PPS) ≥60%
• Clinically significant Anxiety defined as SIGH-A >17 at Screening
• Have an identified support person: agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
• Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study. A person of childbearing potential is anyone assigned female or intersex at birth who has experienced menarche and who has not undergone surgical sterilization (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or has not completed menopause. Menopause is defined clinically as 12 months of amenorrhea in a person over age 45 in the absence of other biological, physiological, or pharmacological causes.

You may not qualify if…

• Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:
• Congestive heart failure
• Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval > 450)
• Recent acute myocardial infarction or evidence of ischemia
• Malignant hypertension
• Congenital long QT syndrome
• Acute renal failure
• Severe hepatic impairment
• Respiratory failure
• Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure >140/90 mmHg.
• Significant central nervous system (CNS) pathology. Some examples include:
• Primary or secondary cerebral neoplasm
• Epilepsy
• History of stroke
• Cerebral aneurysm
• Dementia
• Delirium
• Primary psychotic or affective psychotic disorders. Some examples include current or past DSM-5 criteria for:
• Schizophrenia spectrum disorders
• Schizoaffective disorder
• Bipolar I with psychotic features
• Major Depressive Disorder with psychotic features
• Family history of first-degree relative with psychotic or serious bipolar spectrum illness. Examples include first-degree relative with:
• Schizophrenia spectrum disorders
• Schizoaffective disorder

Where it is running

• University of Colorado Anschutz Medical campus (CU AMC) — Aurora, Colorado, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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