Actively Recruiting
TRIP - Treatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
G
Gateway for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and anxiety in people with advanced cancer who are currently receiving maintenance therapy. This Phase 2 trial aims to see if at least 20% of eligible participants agree to join and if 60% complete the two treatment doses. The study also explores improvements in quality of life, psychosocial well-being, functional status, cancer treatment adherence, inflammatory markers, brain function through fMRI, and symptom impact measures. Participants will be randomly assigned to receive either psilocybin (25 mg) or a placebo of 100 mg niacin, both given by mouth. The study includes two doses of treatment, with careful monitoring and assessments before, during, and after these sessions. The trial uses a quadruple-blind design so that participants, caregivers, researchers, and analysts do not know who receives psilocybin or placebo. During the study, participants will attend all treatment and follow-up visits at the cancer center, complete questionnaires and clinical interviews, and undergo brain imaging, blood tests, and immune monitoring. Researchers will track safety and adverse events throughout the approximately one-year participation period. They will also measure changes in depression, anxiety, quality of life, and biological markers to understand the impact of psilocybin-assisted psychotherapy on these symptoms and cancer treatment adherence.
CONDITIONS
Brief Title
Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have one of the following 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, anal, or MSI-high
- Have locally advanced, recurrent, or metastatic incurable cancer that is stable and has partially responded or progressed after at least one standard therapy
- No prior grade 3 adverse events on current cancer treatment
- Age 25 years or older
- Have a psychiatric diagnosis related to cancer stress, confirmed by a psychiatrist
- Life expectancy of at least 6 months
- ECOG performance status of 0, 1, or 2
- No major cognitive impairment and oriented to person, place, and time
- Willing to travel for all treatment and follow-up visits
- Agree to abstain from nicotine and psychoactive drugs for specified times around treatment
- Free from regularly scheduled psychotropic medications for required time before study
- Have a responsible person for transportation after psilocybin sessions
- Fluent in English
You will not qualify if you...
- History of depression before cancer diagnosis
- High risk of suicide or recent suicidal thoughts or behaviors
- History of bipolar disorder, psychosis, or seizures
- Serious comorbid conditions including certain cancers or surgeries affecting function
- ECG with QTc greater than 450
- Presence of metal implants
- Significant liver enzyme abnormalities or bilirubin elevation
- Pregnant or not using approved contraception if of child-bearing potential
- Family history of schizophrenia, psychotic disorders, or bipolar disorder
- Actively progressing disease
- Vulnerable populations such as children or cognitively impaired
- Brain metastases
- High blood pressure or heart rate indicating hypertensive crisis risk
- Unstable medical conditions or serious lab abnormalities
- Significant central nervous system pathology
- High risk of adverse emotional or behavioral reactions
- Active substance use disorders or extensive hallucinogen use
- Concurrent use of certain medications or substances including niacin
- Allergy or intolerance to study drugs
- Participation in other similar clinical trials
- Niacin contraindications such as active liver disease or peptic ulcer
- Blood pressure above set dangerous thresholds preventing dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the two dosing sessions as per protocol
Participants receive two doses of psilocybin-assisted psychotherapy or placebo while continuing their maintenance cancer therapy.
2 dosing sessions with accompanying psychotherapy visits
Duration - Up to 1 year
Participants are monitored for safety, adverse events, and effects on depression, anxiety, quality of life, and immune markers.
Regular follow-up visits over approximately 1 year
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Moran Amit, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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