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Psilocybin Therapy for Chronic Low Back Pain

NCT05351541 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Chronic Low-back Pain

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)

Sponsors & Collaborators

  • Joshua Woolley, MD, PhD

    lead OTHER

Principal Investigators

  • Joshua Woolley · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-07-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351541 on ClinicalTrials.gov