NCT06200155

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

TRIP - TReatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Objective To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for participants with depression and/or anxiety who are being actively treated for advanced cancer. Feasibility will be measured as: At least 20% of eligible participants consent and at least 60% of consented participants complete the two doses of treatment. Secondary Objectives 1. Determine whether psilocybin-assisted psychotherapy improves measures of quality of life (e.g., sleep, pain, functional status) and psychosocial well-being (e.g., finding meaning and post-traumatic growth), as measured by the following: PHQ-9, GAD-7, PROMIS-10, PROMIS-A, PROMIS-D, MEQ30 (mystical experience), Flourishing scale, mDES, 5D-ASC (altered states), and Posttraumatic Growth Inventory. 2. Determine whether psilocybin-assisted psychotherapy improves functional status per clinician-rated outcome measures. 3. Assess the effects of psilocybin-assisted psychotherapy on cancer treatment adherence determined by the likelihood that participants will follow the prescribed treatment (adherence) and continue the treatment for the duration prescribed (persistence) for these maintenance therapies. 4. Measure the change in inflammatory markers (IL6, TNF, and CRP) and in frequency and activation status of peripheral immune cell populations assessed by immune monitoring through flow cytometry. 5. Examine changes in central nervous system plasticity through the use of fMRI, specifically changes in 5-HT2A-rich and higher-order functional networks, as well as a global increase in brain network integration. 6. Evaluate the Impact on MDASI measurements.

Conditions

• Depression, Anxiety
• Psilocybin-Assisted Psychotherapy
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Psilocybin	Given by PO
OTHER	Niacin	Given by PO

Timeline

• Start date: 2024-04-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-01-10
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study