Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Phase II, single-group supportive-care study (n=20) of low-dose oral psilocybin (source: Psilocybe mexicana) given twice weekly for 4 weeks (8 doses) with preparatory and integration psychotherapy in cancer patients with chronic opioid-treated pain.
Details
This single-group Phase II study evaluates safety, tolerability, and feasibility of low-dose psilocybin combined with psychotherapy for chronic cancer-related pain in patients requiring opioids.
Participants attend two preparatory psychotherapy sessions, receive oral psilocybin twice weekly for four weeks (8 doses total) with integration therapy at sessions 2, 4, and 6 (three 90-minute sessions), and may have optional additional therapy during follow-up.
Exploratory assessments include fMRI, blood and urine biomarkers, and patient-reported measures to probe mechanisms (resting brain network activity, inflammation, psychological processes) and preliminary efficacy on pain and opioid use; follow-up visits at days 28–34, 56, and 84.