Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy
Recruiting · Houston, Texas
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults age 25 or older with one of these tumor types: non-small cell lung carcinoma, renal cell carcinoma, urothelial carcinoma, prostate cancer, head and neck squamous cell carcinoma, ovarian cancer, breast cancer, gastric/GEJ cancer, cervical cancer, anal cancer, or MSI-high
- •People with locally advanced, recurrent, or metastatic cancer that cannot be cured, and that has partially responded or progressed after at least 1 standard treatment; disease must be stable with no progression for 3 months or more on the current regimen
- •People who have a DSM-V psychiatric diagnosis (confirmed using the SCID interview) such as generalized anxiety disorder, acute stress disorder, posttraumatic stress disorder, major depressive disorder, dysthymic disorder, or certain adjustment disorders related to cancer stress
- •People with life expectancy of at least 6 months and ECOG performance status 0, 1, or 2 (a measure of how well someone can do daily activities)
- •People who can travel to MD Anderson for all sessions, are willing to follow rules about nicotine, psychoactive drugs, and drug testing, and can communicate in English
🚫 You may not be able to join if…
- •People who had depression before their cancer diagnosis
- •People with significant suicide risk, including recent suicidal thoughts or any suicidal behavior within the past year
- •People with a history of bipolar disorder, psychosis, or seizures
- •People with certain brain-related problems, including brain metastases, or people with a serious problem that limits thinking and orientation
- •People with certain safety issues such as QTc on ECG greater than 450, pregnancy, or blood pressure/heart-rate levels suggesting hypertensive crisis (BP above 140/90 mmHg or HR above 90 bpm at screening/baseline/session time)
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 25–any age
- ✓Have Depression or Anxiety
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. This study may also compensate you for your time and travel — the team will tell you the amount before you join. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06200155 · Locations: Texas