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Active, not recruitingPhase 1 / Phase 2

Psilocybin Therapy for Chronic Low Back Pain

NCT05351541 · POP · Joshua Woolley, MD, PhD

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
30
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in pain interference

    Measured over Baseline, 1-month after psilocybin session

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Age 25 to 70 years old * Comfortable speaking and writing in English * Diagnosed with chronic low back pain * Able to attend all in-person visits at UCSF as well as virtual visits * Has tried at least two previous medications/ procedures and physical therapy trials for low back pain Exclusion Criteria: * Chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection * Low back pain with radiation below the knee * Low back pain with neurologic signs present * Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, antipsychotics, and stimulants * A health condition that makes study unsafe or unfeasible, determined by study physicians

Where

1 study site

FacilityCityRegionCountry
University of California San FranciscoSan FranciscoCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05351541 on ClinicalTrials.gov →

Last updated in the registry 2026-04-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

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