A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain (POP)

NCT05351541 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions.

Details

Lead sponsor	Joshua Woolley, MD, PhD
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	30
Start date	2023-12-01
Completion	2026-09

Conditions

• Chronic Low-back Pain

Interventions

• Psilocybin therapy with Zolpidem and Modafinil
• Psilocybin therapy with Zolpidem
• Psilocybin therapy with Modafinil
• Psilocybin therapy with Placebo

Primary outcomes

• Change in pain interference — Baseline, 1-month after psilocybin session
  The Brief Pain Inventory-Interference subscale (BPI) will be used to assess how pain interferes with a variety of daily activities (e.g., walking, lifting, mood, sleep, relationships). Seven items are rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total possible score ranging from 0 to 70. Higher scores represent greater interference from pain.

Countries

United States