A Study of Psilocybin and Talk Therapy to Help People with Breast or Ovarian Cancer Worry Less About It Returning
The main goal of this study is to find out if one dose of psilocybin (a drug from certain mushrooms) and talk therapy can help people feel less scared about their cancer returning. We also want to make sure this treatment is safe.
Why this Research Matters
This study will include 10 people with early or advanced cancer. It will test if one dose of psilocybin (25 mg) with talk therapy is safe and can help people worry less about cancer returning and feel better emotionally. Psilocybin comes from certain psychedelic mushrooms and can change how people think and feel. It is not yet approved by the FDA for medical use, so this study is experimental and has special permission.
What to Expect
To join this study, you will have two visits to see if you qualify. You will have medical and mental health exams to find out if you can join the study. If you join, you will have up to four therapy sessions over two weeks before taking the study medicine to talk about your medical history, how you are feeling, and what to expect during the study. If everything looks good, you will take the study medicine in a capsule during a special session. During the session, you will wear eyeshades and headphones and listen to music. Two therapists will stay with you the whole time to support you. You will need to stay in the room for at least eight hours, and someone you trust will take you home and be available to assist you that night. The next day, you will have your first therapy session to talk about your experience. Over the next eight weeks, you will have three more therapy sessions to help you understand your experience. You will also have follow-up check-ins at 1, 4, 8, 12, and 24 weeks after the medicine session. During these visits, you will answer questions about your mood, pain, thoughts, and health. The team will also check for changes in your medicine or health. Your final visit, 24 weeks after the medicine session, will be the end of the study. To take part, you must come to in-person visits for screening, baseline, medicine day, and final check-up. These visits may include medical history, physical exams, heart tests (ECG), safety checks like blood and urine tests, and mental health assessments. You will also have study visits for psychological tests or therapy sessions, which can be done online if you want. Some sessions may be recorded.
Study Duration
This study will last about 6 months. You will have about 11 visits, totaling around 43 hours spread over 24 weeks.
Who can Participate
You may be able to join if you:
- Are a woman who has early-stage breast cancer with a low chance of returning or late-stage ovarian cancer with a high chance of returning
- May have recently finished surgery or chemotherapy
- Are able to take care of yourself
- Are 21 years and older
- Have a qualifying score on a survey called the Fear of Recurrence Inventory at the first two study visits
Study ID
Protocol Number: 23-1455
More information available at ClinicalTrials.gov: NCT06430541
Compensation Information
Meet the Team
Principal Investigator