RecruitingAdvanced Cancer
Psilocybin Therapy in Advanced Cancer
Eligible age
21–100 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: NYU Langone Health
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
Where it's recruiting
Source: ClinicalTrials.gov · NCT05398484 · last updated 2025-12-04