NCT06801041

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Objective: To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for cancer survivor patients with depression and/or anxiety. Feasibility will be measured as: At least 20% of eligible patients consent (inclusion rate), at least 60% of consented patients completing the two doses of treatment (treatment completion rate), and at least 80% and 65% consenting patients completing assessments at the 2- and 6-month follow-ups (adherence rates), respectively. 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, PIQ (altered states), and Posttraumatic Growth Inventory. 2. Determine whether psilocybin-assisted psychotherapy improves functional status per clinician-rated outcome measures. 3. 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. 4. 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. 5. Evaluate the Impact on MDASI measurements.

Conditions

• Depression
• Anxiety
• Cancer

Interventions

Type	Name	Description
DRUG	Psilocybin	Participants will recive treatment by mouth on an outpatient basis.

Timeline

• Start date: 2025-05-23
• Primary completion: 2027-03-31
• Completion: 2029-03-31
• First posted: 2025-01-30
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study