NCT05398484

Psilocybin Therapy in Advanced Cancer

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (anxiety, depression) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with late-stage or advanced cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center RCT comparing a single 25mg oral 'high' dose of psilocybin to a single 100mg dose of niacin (active placebo), both delivered in conjunction with a psychotherapy platform.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Psilocybin 25 mgs	One capsule containing 25mg of psilocybin will be administered with water orally. The appearance of psilocybin is Size 2 HPMC opaque.
DRUG	Niacin 100mg	One capsule contains 100mg of niacin will be administered with water orally. The appearance of the active placebo is Size 2 HPMC opaque.
BEHAVIORAL	Psychotherapy	The manualized psychotherapy platform will consist of 6 hours of preparatory psychotherapy (prior to the single medication session) and 8 hours of integration psychotherapy following the dosing session.

Timeline

• Start date: 2023-05-24
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-06-01
• Last updated: 2025-12-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study