This open-label, Phase II trial (n=20) will investigate the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors experiencing depression and/or anxiety.
The study, sponsored by M.D. Anderson Cancer Center, aims to assess the treatment’s impact on quality of life, psychosocial well-being, and functional status. It will also examine changes in inflammatory markers and brain network integration through fMRI.
Participants will receive psilocybin in a structured therapeutic setting, with primary outcomes including treatment adherence and adverse event monitoring. The trial is set to begin in June 2025 and is expected to conclude by March 2029.
Trial Details
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. 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.Trial Number NCT06801041
Sponsors & Collaborators
National Cancer InstituteThis company doesn't have a full profile yet, it is linked to a clinical trial.
University of Texas
The University of Texas is conducting research with psychedelics across locations in Houston, Austin, Dallas and San Antonio.