A Study on Psilocybin with Talk Therapy to Help with Emotional and Mental Distress in People with Advanced Cancer ***Cancer Diagnosis Only***
This study will test if one dose of psilocybin, given with talk therapy, can safely help people with advanced cancer feel less anxious, less depressed, and improve quality of life. We will compare it to a placebo (inactive medicine) called niacin given with the same kind of talk therapy.
Why this Research Matters
This study will include 200 people with advanced cancer at two locations. It will test if one dose of psilocybin (25 mg) with talk therapy is safe and can help lower anxiety, depression, and feelings of hopelessness or fear of the future. Some people will get psilocybin, and others will get a fake medicine called niacin (100 mg) that looks the same but does not have psilocybin. 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. After the first part of the study, called the open-label phase, participants can choose to get one dose of psilocybin (25 mg) with talk therapy again.
What to Expect
To join this study, you will first have a visit to see if you qualify. You will have medical and mental health exams to find out if you can join the study. The study has two parts: the first is a randomized, double-blind, controlled trial (called RCT), and the second is an optional open-label phase after the first part ends. The medicine used in this study is psilocybin, which is made in a lab. You will either get a single dose of psilocybin (25 mg) or a fake medicine (placebo) called niacin (100 mg). Niacin looks just like psilocybin but does not have the active ingredient. If you join, you will be randomly placed into one of two groups. You won’t know which medicine you get, and neither will the study staff. This is called “double-blind.” Both medicines will be given as a pill to swallow with water during a day-long session with close supervision. Niacin can cause some mild physical feelings, so it helps keep the study fair by making it hard to tell which medicine you got. To take part, you must come to in-person visits for screening, baseline, medicine day, and final check-up. These visits 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. After your medicine session, you must have a support person with you to help you. If you finish the first part safely, you can choose to get psilocybin again in the open-label phase. This time, everyone will know you are getting psilocybin, and you will have more follow-up visits over 12 weeks with similar therapy support.
Study Duration
The first part of the study (called the randomized controlled trial or RCT) will last about 4.5 months. If you only join this part, you will have about 15 visits, totaling around 42 hours, over 15 to 26 weeks. If you are eligible, you can join a second part called the Open-Label Extension Phase. This part adds about 11 more visits and takes about 25 hours over 13 weeks. If you take part in both parts, the whole study will take about 67 hours spread over 28 to 39 weeks.
Who can Participate
You may be able to join if you:
- Have advanced cancer diagnosis
- Have ongoing depression, anxiety, or feelings of hopelessness
- Can take care of yourself and have no serious organ problems
- Are 21 years old or older
- Are willing to stop taking antidepressant medicines during the study
Study ID
Protocol Number: 22-1207
More information available at ClinicalTrials.gov: NCT05398484
Compensation Information
Meet the Team
Principal Investigator