Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer

Description

PRIMARY OBJECTIVE:

I. To determine the safety and acceptability of psilocybin-assisted psychotherapy with non-small cell lung cancer (NSCLC) patients.

SECONDARY OBJECTIVE:

I. To determine the efficacy of psilocybin-assisted therapy in the reduction of depression and the impact of treatment on quality of life, cancer-related stress, and existential distress.

OUTLINE:

Patients participate in two preparation therapy sessions over 4 hours each on days 7 and 14, then patients receive psilocybin orally (PO) on day 21 and participate in a single dosing therapy session for over 8-10 hours on study. Patients also complete two post-dosing therapy sessions over 2 hours each on days 22 and 28 on study. Patients additionally undergo blood and urine sample collection throughout the study.

After completion of study treatment, patients are followed up at 4 and 12 weeks.