Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID05066308

Evaluation of Cannabidiol for Reduction of Brain Neuroinflammation in Chronic Low Back Pain Patients

Led by Massachusetts General Hospital · Updated on 2026-02-06

80

Participants Needed

1

Research Sites

15 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether cannabidiol (CBD), a non-intoxicating compound from the cannabis plant, can reduce brain neuroinflammation in people with chronic low back pain (cLBP), with or without mild-to-moderate depression. This Phase 2 randomized, double-blind trial uses advanced brain imaging techniques to study inflammation and brain function related to rewards and losses. Participants receive either Epidiolex (a purified CBD oral solution) or a placebo. The dosing starts at 2.5 mg/kg twice daily, increasing weekly up to 10 mg/kg twice daily over 4 weeks. Any participant unable to tolerate a dose can reduce or delay dose increases. Participants take the treatment with meals, and brain scans are done before and after the 4-week treatment. Throughout the study, participants complete brain PET/MRI scans to measure neuroinflammation and brain activity, along with clinical pain and depressive symptom assessments. Researchers track changes in brain inflammation, pain levels, and mood from baseline to week 4. Safety and response to treatment are closely monitored, with total participation lasting about one month.

CONDITIONS

Brief Title

Cannabidiol for Reduction of Brain Neuroinflammation

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • Ability to provide written, informed consent
  • Fluent in English
  • Average worst daily pain of at least 4 on a 0-10 scale, present at least 50% of days weekly
  • Stable pain treatment for the previous 4 weeks
  • Diagnosis of chronic low back pain ongoing for at least 6 months
  • High or mixed affinity binding to [11C]PBR28 identified by TSPO gene polymorphism
Not Eligible

You will not qualify if you...

  • Outpatient surgery within 2 weeks or inpatient surgery within 1 month prior to scanning
  • Elevated liver enzymes (ALT/AST) more than 3 times normal and bilirubin more than 2 times normal
  • Interventional pain procedures within 6 weeks before or during study
  • Surgical intervention or opioid regimen changes during study
  • Contraindications to fMRI or PET scans (e.g., pacemaker, metal particles, claustrophobia)
  • Implanted spinal cord stimulator for pain
  • History of neurological or major medical illness unless resolved
  • Severe psychiatric illness requiring hospitalization in past year
  • Harmful alcohol use (AUDIT score ≥16)
  • Pregnancy or breastfeeding
  • History of head trauma requiring hospitalization
  • Major cardiac event in past 10 years
  • Recreational drug use in past 3 months
  • Use of cannabis or CBD products 2 weeks before and during study
  • Use of immunosuppressive medications within 2 weeks
  • Current CNS infections
  • Epilepsy
  • Use of valproate or clobazam
  • Use of certain medications affecting drug metabolism (list provided)
  • Use of CNS depressants that react unsafely with CBD
  • Opioid use ≥30 mg morphine equivalents per month
  • Suicidal behavior or self-injury history in recent years
  • Allergy to sesame oil or Epidiolex ingredients
  • Other physician-noted contraindications to CBD
  • Significant changes in drug or pain treatment since screening
  • Unable to safely participate or provide reliable data

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive either cannabidiol (CBD) or placebo taken orally twice daily with meals. The dosage is gradually increased each week over 4 weeks, starting at 2.5 mg/kg twice daily and reaching 10 mg/kg twice daily by week 4, with dose adjustments allowed for tolerance.

Multiple visits during treatment for dosing and assessments, including PET/MRI scans

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

J

Jodi M Gilman, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Published Research Related To This Trial

Study protocol for a phase II, double-blind, randomised controlled trial of cannabidiol (CBD) compared with placebo for reduction of brain neuroinflammation in adults with chronic low back pain.

Chelsea K Pike, Minhae Kim, Kristina Schnitzer...

https://pubmed.ncbi.nlm.nih.gov/36123113