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Psilocybin Therapy for Chronic Low Back Pain

This study is exploring whether psilocybin therapy can help people better manage chronic low back pain. Researchers want to see if psilocybin, sometimes with other medications like Zolpidem or Modafinil, can improve how you cope with your pain. You might be able to join if you are 25 to 70 years old, speak English, have chronic low back pain, and have tried at least two other treatments. The main goal is to see how much your pain interferes with your daily life one month after a psilocybin session. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 30 participants. It tests different combinations of psilocybin with Zolpidem, Modafinil, or a placebo.
What's involved
You would attend two preparation sessions, one dosing session, three integration sessions to discuss your psilocybin experience, and several follow-up sessions. These include both in-person visits at UCSF and virtual visits.
Compensation
Not stated in the trial record.
Follow-up
Your pain interference will be measured at baseline and again one month after your psilocybin session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05351541

Psilocybin Therapy for Chronic Low Back Pain

Active, Not Recruiting
PHASE1Ages 25–70InterventionalTreatment
Joshua Woolley, MD, PhD
~30 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Psilocybin therapy with Zolpidem and ModafinilPsilocybin therapy with ZolpidemPsilocybin therapy with ModafinilPsilocybin therapy with Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pain interference
Measured over Baseline, 1-month after psilocybin session

Conditions

Chronic Low-back Pain

Explore related trials

Chronic low back pain

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Joshua Woolley · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Change in pain interferenceBaseline, 1-month after psilocybin session

    The Brief Pain Inventory-Interference subscale (BPI) will be used to assess how pain interferes with a variety of daily activities (e.g., walking, lifting, mood, sleep, relationships). Seven items are rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total possible score ranging from 0 to 70. Higher scores represent greater interference from pain.