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RECRUITING
NCT05351541
PHASE1/PHASE2

Psilocybin Therapy for Chronic Low Back Pain

Sponsor: Joshua Woolley, MD, PhD

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

25 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-12-01

Completion Date

2026-04

Last Updated

2025-03-20

Healthy Volunteers

No

Interventions

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)

Locations (1)

University of California San Francisco

San Francisco, California, United States