NCT05351541

Psilocybin Therapy for Chronic Low Back Pain

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Joshua Woolley, MD, PhD · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Chronic pain is associated with higher levels of pain-related distress, depression, emotional dysfunction, helplessness, hopelessness, and suicidality. Psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain. Previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes, but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively. The investigators will determine whether psilocybin therapy improves patients' ability to cope with chronic low back pain. If psilocybin therapy is an effective treatment in this population, its use could be incorporated into interventions for chronic low back pain and other psychological conditions.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
DRUG	Psilocybin therapy with Zolpidem and Modafinil	1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
DRUG	Psilocybin therapy with Zolpidem	1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)
DRUG	Psilocybin therapy with Modafinil	1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)
DRUG	Psilocybin therapy with Placebo	1-30 mg (oral administration), and placebo (oral administration)

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2022-04-28
• Last updated: 2025-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study