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 psilocybin 1mg) 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.

Topic Depression Anxiety Palliative Care
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 November 2022
End date 01 January 2027
Chance of happening 89%
Phase Phase II Phase III
Design Blinded
Type Interventional
Generation First
Participants 200
Sex All
Age 21- 100
Therapy Yes

Trial Details

This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (depression, anxiety) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with late-stage (stage 3 or 4) 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 1mg 'very low' (clinically non-therapeutic) dose active control psilocybin, both delivered in conjunction with a psychotherapy platform.

NCT Number NCT05398484

Sponsors & Collaborators

NYU Langone Health
This company doesn't have a full profile yet, it is linked to a clinical trial.

National Cancer Institute
This company doesn't have a full profile yet, it is linked to a clinical trial.

Data attribution

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