Actively Recruiting
TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
20
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.
CONDITIONS
Official Title
TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a solid or blood-related cancer that does not involve the brain
- Cancer treated with no evidence of disease for the past 6 months
- Age 18 years or older
- Diagnosed with one or more psychiatric disorders related to cancer stress, such as generalized anxiety disorder, acute stress disorder, PTSD, major depressive disorder, dysthymic disorder, or adjustment disorders
- Have an ECOG performance status of 0, 1, or 2
- No major cognitive impairment and oriented to person, place, and time
- Willing to travel to MD Anderson Cancer Center for all treatment and follow-up sessions
- Agree to avoid nicotine for at least 8 hours before fMRI scans
- Will abstain from psychoactive drugs, including alcohol, 48 hours before and 12 hours after psilocybin sessions
- Free from regularly scheduled antidepressant or anxiolytic medications for at least 2 weeks before study start
- Discontinue certain medications affecting psilocybin metabolism 5 half-lives before treatment
- Have third-party transportation by licensed driver after psilocybin sessions
- Fluent in English
You will not qualify if you...
- High risk of suicide or recent suicidal behavior
- History of bipolar disorder or psychosis, including schizophrenia
- Serious other medical conditions limiting function or communication
- Pregnant or not using effective birth control if of child-bearing potential
- First-degree relatives with schizophrenia or bipolar disorder
- Current malignancy treated with palliative intent
- Vulnerable populations such as children or cognitively impaired individuals
- Patients with brain metastases
- High blood pressure or heart rate above specified levels
- Unstable medical conditions or serious heart, kidney, liver, or respiratory problems
- Significant central nervous system diseases like epilepsy, recent stroke, untreated aneurysm, dementia, or delirium
- High risk of adverse emotional or behavioral reactions
- Active moderate or severe substance use disorders
- Extensive use of hallucinogens recently or in lifetime
- History of hallucinogen persisting perception disorder
- Use of certain medications or supplements interfering with psilocybin
- Positive urine drug test for non-prescribed substances
- Psychiatric conditions preventing safe therapy or rapport
- Allergies or intolerance to study drug materials
- Participation in other clinical trials for anxiety, depression, or existential distress
- Patients with non-fMRI compatible implants will not undergo fMRI scans but may participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Moran Amit, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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