NCT05398484View on ClinicalTrials.gov

Psilocybin Therapy in Advanced Cancer

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

May 24, 2023

Primary Completion Date

January 1, 2027

Study Completion Date

January 1, 2027

Conditions
Advanced Cancer
Interventions
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.

Trial Locations (2)

10016

RECRUITING

NYU Langone Health, New York

80045

RECRUITING

University of Colorado Anschutz Medical campus (CU AMC), Aurora

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

NYU Langone Health

OTHER