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NCT05398484 · ClinicalTrials.gov registry record · Phase 2
Psilocybin Therapy in Advanced Cancer
A Phase 2 study of Advanced Cancer, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 2
- Study locations
NCT05398484 is a Phase 2 study of Advanced Cancer that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 200 participants, below the 245-participant average among 122 other Advanced Cancer trials with a reported enrollment target (18% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05398484, a Phase 2 study of Advanced Cancer, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 122 other Advanced Cancer trials with a reported enrollment target (18% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
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.
NCT05398484 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, New York.
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.
What interventions are being tested in trial NCT05398484?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), Psilocybin 25 mgs (DRUG), Niacin 100mg (DRUG).
Who is sponsoring clinical trial NCT05398484?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.