NIH-funded research R01 grant

Psilocybin-assisted Psychotherapy for Fear of Cancer Recurrence in Early-Stage Breast Cancer

Official title: Psilocybin-assisted Psychotherapy to Treat Fear of Cancer Recurrence in Early- Stage Breast Cancer

Funded at New York University School of Medicine · NIH-11344227 · Data updated 2026-11-12

A study will test whether a one-time psilocybin-assisted psychotherapy session helps reduce fear of cancer returning in women with early-stage breast cancer.

More Breast Cancer research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionNew York University School of Medicine
NIH-funded
Lab location1 site (New York, United States)
Project startSeptember 8, 2026
Project endAugust 31, 2031
Funding year2026
Award (this year)$693,638
NIH project number1R01CA312541-01
Project IDNIH-11344227 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are adults with early-stage breast cancer who have significant fear of recurrence and are eligible for psilocybin-assisted therapy under study protocols.

Less likely to help

Individuals with contraindications to psilocybin or psychotherapy, or those not seeking this treatment approach, may not benefit.

What this research studies

If you are a woman with early-stage breast cancer and experiences fear that the cancer could come back, this trial would explore whether a guided psychotherapy session with a psilocybin-assisted dose could ease that worry. Participants would engage in psychotherapy alongside a controlled psilocybin experience under medical supervision, aiming for lasting reductions in anxiety, depression, and existential distress. The goal is to see if this approach provides meaningful and durable relief where current options are limited. The study builds on prior findings in cancer patients and seeks to confirm effects in a homogenous early-stage breast cancer group.

Why it matters

Potential benefit: If successful, participants may experience reduced fear of recurrence and improved quality of life.

How similar studies have gone: Earlier pilot trials in cancer patients suggest rapid and durable improvements in anxiety and existential distress with psilocybin-assisted therapy, but robust RCT data in early-stage breast cancer are needed.

Where this research is happening

  • New York University School of Medicine
    New York, United States
    Active

Researchers

  • Principal investigator: Ross, Stephen — New York University School of Medicine
  • Study coordinator: Ross, Stephen

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.