Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy
Randomized, double-blind, parallel Phase II trial (n=30) testing psilocybin-assisted psychotherapy (25 mg, two sessions) versus niacin placebo for depression and/or anxiety in patients with advanced cancer.
Details
This is a randomized, quadruple-blind, parallel-group Phase II trial at MD Anderson Cancer Center assessing feasibility, safety, and effect-size estimates of psilocybin-assisted psychotherapy (25 mg, two dosing sessions) for depression and/or anxiety in patients receiving maintenance therapy for advanced cancer.
Secondary outcomes include measures of quality of life and psychosocial well-being (PHQ-9, GAD-7, PROMIS instruments, MEQ30, 5D-ASC, Flourishing scale, Posttraumatic Growth Inventory), clinician-rated functional status, treatment adherence, immune markers (IL-6, TNF, CRP) and exploratory fMRI measures of network integration.
Safety assessments include adverse events, vitals, ECG, labs, and screening exclusions for psychosis, bipolar disorder, high suicide risk, significant cardiac or hepatic abnormalities, and active substance use disorder. Participants receive preparatory and integrative psychotherapy around dosing sessions.