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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: Recruiting Phase 2 study of Advanced Cancer, sponsored by NYU Langone Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) measures the level of anxiety in participants. Scoring is based on a 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild anxiety, 17-23 moderate anxiety, and scores over 24 are indicative of severe anxiety; the maximum score being 52.
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 |
What NCT05398484 shows while recruiting
NCT05398484 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 245-participant average among 122 other Advanced Cancer trials with a reported enrollment target (18% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Advanced Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05398484's enrollment target sits among peer trials
200 30th of 122 higher than 90 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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