Active — Not RecruitingPhase 1/2

Psilocybin Therapy for Chronic Low Back Pain

United States30 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range25 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in pain interference

Timeframe: Baseline, 1-month after psilocybin session

Trial details

NCT IDNCT05351541

SponsorJoshua Woolley, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Chronic Low-back Pain trials