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Psilocybin Therapy in Advanced Cancer
NCT05398484 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- BEHAVIORAL Psychotherapy
- DRUG Psilocybin 25 mgs
- DRUG Niacin 100mg
Study Locations (2)
Colorado
- University of Colorado Anschutz Medical campus (CU AMC) — Aurora
New York
- NYU Langone Health — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-05-24 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05398484
The ClinicalTrials.gov registry entry for NCT05398484 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Cancer appearing as the primary indexed condition, and to 3 interventions — of which Psychotherapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05398484 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Colorado, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05398484 about?
NCT05398484 is a clinical study titled "Psilocybin Therapy in Advanced Cancer". 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)...
What is the current status of trial NCT05398484?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2023-05-24. Estimated completion is 2027-01-01.
What conditions does trial NCT05398484 study?
This clinical trial studies the following conditions: Advanced Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05398484?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), Psilocybin 25 mgs (DRUG), Niacin 100mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05398484?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05398484 being conducted?
This trial has 2 study locations across Colorado, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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