TRIPS – Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
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.
Details
This single-group, open-label study will deliver two outpatient psilocybin dosing sessions with preparatory and integration psychotherapy to cancer survivors with depression and/or anxiety to assess feasibility and safety.
Primary outcomes cover feasibility metrics (consent, treatment completion, follow-up adherence), safety (AEs/SAEs, vitals, ECG, labs) and effect-size estimates on depression and anxiety scales (PHQ-9, GAD-7).
Secondary assessments include quality-of-life measures (PROMIS, MEQ30, Flourishing scale), clinician-rated functioning, inflammatory markers (IL-6, TNF, CRP), immune phenotyping, and fMRI measures of brain network integration and 5-HT2A-rich circuits.