Psilocybin-Assisted Psychotherapy for Depression and Anxiety in Adults with Advanced Cancer on Maintenance Treatment

What this Trial Is About

Researchers are evaluating psilocybin-assisted psychotherapy for people with depression andor anxiety who are actively receiving treatment for advanced cancer. This Phase 2 trial aims to study the feasibility, safety, and potential effects of this therapy on psychological symptoms and quality of life. The study also looks at how this treatment may affect cancer therapy adherence and biological markers related to inflammation and brain function. Participants are randomly assigned to receive either psilocybin 25 mg or a placebo 100 mg of niacin by mouth. The study uses a quadruple-blind design to compare the effects of these interventions. The treatment involves two doses of psilocybin-assisted psychotherapy, with careful monitoring throughout. The trial will assess various psychological, functional, and biological outcomes during and after treatment. During the study, participants attend treatment and follow-up sessions at the cancer center and complete a range of assessments including questionnaires on mood, anxiety, quality of life, and mystical experiences. Researchers will also use brain imaging fMRI and blood tests to study immune function and brain plasticity. Safety and adverse events will be tracked throughout the average one-year study period. Participants must be willing to complete all visits and evaluations as required.

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