HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by Massachusetts General Hospital · Updated on 2026-02-06
80
Participants Needed
1
Research Sites
15 weeks
Total Duration
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 mgkg twice daily, increasing weekly up to 10 mgkg 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 PETMRI 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
Cannabidiol for Reduction of Brain Neuroinflammation
J
Jodi M Gilman, PhD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Massachusetts General Hospital
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | CBD (Epidiolex) | Placebo | Standard care |
|---|---|---|---|
| What it is | An investigational oral formulation of purified cannabidiol (Epidiolex) evaluated for its effect on brain neuroinflammation in chronic low back pain. | A placebo oral solution matching Epidiolex formulation but without cannabidiol, used as the control arm. | Non‑surgical guideline‑supported treatments for chronic low back pain, including exercise, psychological therapy and NSAIDs or duloxetine when appropriate. |
| Role in trial | Participants receive active CBD treatment. | Participants receive matching placebo. | Represents typical therapeutic options used outside of trial setting, not part of this study. |
| Primary use | Test whether CBD reduces neuroinflammation detected by PET/MRI in patients with chronic low back pain. | Serve as inactive control to assess specific effect of CBD on neuroinflammation. | Guide decisions using current recommended non‑invasive management approaches outside experimental settings. |
| How it is given or performed | Oral Epidiolex solution administered over 4 weeks with dose‑escalation schedule, combined with PET/MRI at baseline and week 4. | Matching oral placebo solution administered over same schedule with PET/MRI assessments. | Typically involves supervised exercise programs, cognitive‑behavioral therapy sessions, and oral NSAID or duloxetine prescriptions as appropriate. |
| Evidence status | Evidence is being generated by this phase II trial; no efficacy data yet for chronic low back pain neuroinflammation reduction. | Placebo serves as control; no efficacy expected beyond trial measures. | Exercise and psychological therapies have modest evidence for improving pain and function; NSAIDs and duloxetine offer limited benefit. |
| Important risks | CBD may affect liver enzymes and interact with medications metabolized by CYP pathways; imaging procedures carry standard imaging safety risks. | Risks related to oral solution and imaging similar to active arm minus CBD‑specific drug risks. | NSAIDs may cause gastrointestinal or cardiovascular effects; duloxetine may lead to nausea or sleep changes; psychological and exercise therapies are generally low‑risk. |
| Important limitations | Small phase II mechanistic design may not indicate clinical pain or depression improvement; TSPO PET signal relevance to symptom change is investigational. | Placebo reflects no active CBD; does not represent usual care options for symptom improvement. | Guideline‑supported therapies may not reduce neuroinflammation and may offer only modest symptom relief. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Chelsea K Pike, Minhae Kim, Kristina Schnitzer...
https://pubmed.ncbi.nlm.nih.gov/36123113/Massachusetts General Hospital
Lead Sponsor
