Actively Recruiting

Phase 2
Age: 25Years +
All Genders
NCT06200155

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

141 weeks

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

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.

CONDITIONS

Official Title

Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

Who Can Participate

Age: 25Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a documented tumor type such as 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 cancer
  • Have locally advanced, recurrent, or metastatic incurable cancer that is stable with no progression for 3 months or more on current treatment
  • No prior severe (grade 3) adverse events on current cancer treatment
  • Age 25 years or older
  • Have a psychiatric diagnosis related to cancer stress, confirmed by a board-certified 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 to MD Anderson Cancer Center for all treatment and follow-up sessions
  • Agree to avoid nicotine products 12 hours before and after psilocybin dosing and on salivary sample collection days
  • Abstain from psychoactive drugs (including alcohol) 48 hours before and 12 hours after psilocybin sessions
  • Free from regular use of psychotropic medications affecting serotonergic neurons for specified washout periods
  • Discontinue specific enzyme inhibitors 5 half-lives before psilocybin dose
  • Have a responsible person to provide transportation home after dosing
  • Fluent in English
Not Eligible

You will not qualify if you...

  • History of depression before cancer diagnosis
  • Significant risk of suicide or suicidal behavior
  • History of bipolar disorder, psychosis, or seizures
  • Serious comorbid conditions limiting function such as CNS or chest malignancies or major surgeries like total laryngectomy
  • ECG with QTc greater than 450
  • Metal implants
  • Liver function abnormalities beyond specified limits
  • Pregnant women or those not using adequate contraception if of child-bearing potential
  • First- or second-degree relatives with schizophrenia, psychotic disorders, or bipolar disorder
  • Actively progressing cancer disease
  • Vulnerable populations such as children or cognitively impaired patients
  • Brain metastases
  • Risk of hypertensive crisis or unstable medical conditions
  • Significant central nervous system diseases like stroke, epilepsy, dementia, or cerebral aneurysm
  • High risk of adverse emotional or behavioral reactions
  • Active moderate or severe substance use disorders (excluding caffeine and nicotine)
  • Extensive recent or lifetime use of serotonergic hallucinogens
  • History of hallucinogen persisting perception disorder
  • Use of certain medications including antidepressants, antipsychotics, mood stabilizers, aldehyde dehydrogenase inhibitors, or niacin without suspension
  • Positive urine drug test for specified substances unless prescribed and stable
  • Psychiatric conditions incompatible with therapy or safe psilocybin exposure
  • Allergy or intolerance to study drug components
  • Participation in other clinical trials for anxiety, depression, or distress
  • Niacin contraindications such as active liver disease or peptic ulcer
  • Blood pressure above specified dangerous levels preventing dosing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Moran Amit, MD

CONTACT

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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