RecruitingPhase 1NCT06430541

Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission


Sponsor

University of Colorado, Denver

Enrollment

20 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.


Eligibility

Sex: FEMALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether psilocybin-assisted psychotherapy can reduce fear of cancer recurrence — a common and distressing source of anxiety in cancer survivors — in women with either early-stage breast cancer (low recurrence risk) or late-stage ovarian cancer (high recurrence risk who are currently in remission). **You may be eligible if...** - You are 21 years or older - You have early-stage breast cancer (Stage 1 or 2) with less than 20% chance of recurrence at 10 years, and you completed primary treatment more than 6 months ago, OR you have Stage 3 or 4 ovarian cancer that is currently in remission, with more than 80% chance of recurrence at 10 years - You are in generally good health (ECOG 0–1) - You experience significant fear of your cancer coming back **You may NOT be eligible if...** - You have unstable medical conditions or significant heart problems (such as heart failure, serious arrhythmias, or recent heart attack) - You have congenital long QT syndrome or a prolonged QT interval on your ECG - You have a personal or family history of psychosis or schizophrenia - You currently have uncontrolled high blood pressure or serious kidney disease - You are currently taking certain psychiatric medications that could interact with psilocybin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors.


Locations(2)

Outpatient CTRC

Aurora, Colorado, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

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NCT06430541


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