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

This interventional trial (n=30) aims to examine the feasibility, safety, and effects of psilocybin-assisted (25mg) psychotherapy on depression and/or anxiety in individuals undergoing treatment for advanced cancer.

The primary objective is to assess the feasibility, safety, and effect size estimates of psilocybin-assisted psychotherapy. Secondary objectives include evaluating its impact on quality of life, psychosocial well-being, functional status, cancer treatment adherence, inflammatory markers, immune cell populations, central nervous system plasticity, and MDASI measurements.

The trial, which is expected to start on June 30, 2024, will be conducted as a Phase II interventional study. Participants will be randomly allocated to two arms: Arm A, where they will receive psilocybin (25 mg), and Arm B, where they will receive a placebo (100 mg of Niacin).

The study will be quadruple-masked, involving participants, care providers, investigators, and outcomes assessors. Moran Amit, MD, from M.D. Anderson Cancer Center, is the principal investigator. The study’s primary completion date is estimated to be December 31, 2026.

Trial Details

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.

Trial Number NCT06200155

Data attribution

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