NCT05398484 is a Phase 2, PHASE3 clinical trial of Psilocybin 25 mgs in Advanced Cancer, sponsored by NYU Langone Health.

Who is sponsoring NCT05398484?

NCT05398484 is sponsored by NYU Langone Health.

What drugs are being tested in NCT05398484?

Interventions in NCT05398484: Psilocybin 25 mgs, Niacin 100mg, Psychotherapy.

What condition does NCT05398484 study?

NCT05398484 studies Advanced Cancer.

Is NCT05398484 still recruiting?

NCT05398484 is currently recruiting now. Last updated 4 December 2025.

Last reviewed 2025-12-04 · How we verify

NCT05398484

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Psilocybin Therapy in Advanced Cancer

Recruiting now Phase 2, PHASE3 Last updated 4 December 2025

What this trial tests

Phase 2, PHASE3 trial testing Psilocybin 25 mgs in Advanced Cancer in 200 participants. Currently enrolling.

Timeline

24 May 2023

Primary endpoint
1 January 2027

1 January 2027

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	200
Start date	24 May 2023
Primary completion	1 January 2027
Estimated completion	1 January 2027
Sites	2 locations across United States

Drugs / interventions tested

Psilocybin 25 mgs — full drug profile →
Niacin 100mg — full drug profile →
Psychotherapy

Conditions studied

Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 21 to 100, any sex, with Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism.
Mitchell JM, Anderson BT. · · 2024 · cited 32× · PMID 37479859 · DOI 10.1038/s41386-023-01656-7
Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases.
Schipper S, Nigam K, Schmid Y, Piechotta V, et al · · 2024 · cited 10× · PMID 39260823 · DOI 10.1002/14651858.cd015383.pub2
Psychedelics for Cancer Pain and Associated Psychological Distress: A Narrative Review of a Potential Strategy.
Belitzky E, Ravani Carvalho LV, Taylor M, Ortiz CN, et al · · 2025 · cited 1× · PMID 40052631 · DOI 10.1002/cam4.70586

Verify or expand the search:

Other recruiting trials for Advanced Cancer

Currently open trials in the same condition.

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NCT07147023 — Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication · NA · active not recruiting

Other NYU Langone Health trials

Trials by the same sponsor.

NCT07214519 — Permanent Supportive Housing Overdose Prevention-2 Study · NA · not yet recruiting
NCT05558267 — Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease · NA · not yet recruiting
NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05398484 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 4 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05398484.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing