Psilocybin Therapy for Chronic Lower Back Pain (POP Trial)

Phase 1 & 2

Recruiting

Led By Joshua Woolley

Research Sponsored by Joshua Woolley, MD/PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 25 to 70 years old

Has tried at least two previous medications/ procedures and physical therapy trials for low back pain

Must not have

Chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection

Low back pain with neurologic signs present

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-week, 1-month, and 3-months after psilocybin session

Awards & highlights

Approved for 5 Other Conditions

Summary

This trial will assess if psilocybin therapy helps people manage chronic low back pain. Participants will get doses of psilocybin, along with other drugs, and counseling.

Who is the study for?

This trial is for adults aged 25-70 with chronic low back pain, who are comfortable in English and can attend sessions at UCSF. They should have tried at least two other treatments without success. It's not for those with pain due to cancer, fractures, infections, or if the pain extends below the knee with neurological signs.

What is being tested?

The study tests psilocybin therapy's effectiveness on chronic low back pain. Participants will receive psilocybin combined with Modafinil, Zolpidem, both drugs or a placebo in various sessions including preparation and follow-ups to discuss their experiences.

What are the potential side effects?

Psilocybin may cause temporary changes in perception, mood swings, dizziness or headaches. Modafinil could lead to insomnia or anxiety while Zolpidem might result in daytime drowsiness or unusual dreams.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 70 years old.

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I have tried at least two treatments and physical therapy for my low back pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My chronic low back pain is due to cancer, a recent fracture, or an infection.

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I have low back pain with signs of nerve issues.

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I have low back pain that spreads below my knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-week, 1-month, and 3-months after psilocybin session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-week, 1-month, and 3-months after psilocybin session

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week, 1-month, and 3-months after psilocybin session for reporting.