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Psilocybin for Breast Cancer

Not yet recruiting at 1 trial location
SR
JS
Overseen ByJasleena Singh
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat fear of cancer recurrence (FCR), psychiatric (anxiety, depression) distress and quality-of-life (QOL), in 100 outpatients with early-stage breast cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center randomized controlled trial (RCT) comparing a single 25mg oral 'high' dose of psilocybin to a single 5mg oral 'low dose psilocybin (active placebo), both delivered in conjunction with a psychotherapy platform.

Who Is on the Research Team?

SR

Stephen Ross, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with early-stage breast cancer who are experiencing anxiety, depression, or fear that their cancer will return. Participants must be outpatients and able to take part in psychotherapy sessions.

Inclusion Criteria

Have an identified support person
Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.
I finished my initial treatment over a year ago.
See 6 more

Exclusion Criteria

Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that would preclude safe participation in the trial as per study physician
I have a primary psychotic or mood disorder.
Clinically significant suicidality or high risk of completed suicide
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin

Trial Overview

The study compares a single high dose (25mg) of psilocybin to a low dose (5mg, acting as an active placebo), both given alongside psychotherapy. The goal is to see if psilocybin helps reduce anxiety, depression, and fear about cancer coming back.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Psilocybin 25mgExperimental Treatment1 Intervention
Group II: Psilocybin 5mgActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

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