RecruitingPhase 2NCT05066308

Cannabidiol for Reduction of Brain Neuroinflammation

Evaluation of Cannabidiol for Reduction of Brain Neuroinflammation


Sponsor

Massachusetts General Hospital

Enrollment

80 participants

Start Date

Jan 4, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study will investigate whether cannabidiol (CBD), the primary centrally and peripherally active non-intoxicating compound in the cannabis plant, exerts anti-neuroinflammatory effects in patients with chronic low back pain (cLBP) with or without mild-to-moderate depression.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether cannabidiol (CBD) can reduce brain inflammation (neuroinflammation) in people with chronic low back pain. Researchers use brain imaging (PET scan) to measure inflammation levels before and after CBD treatment to understand if it has a real biological effect. **You may be eligible if...** - You are aged 18–75 with chronic low back pain ongoing for at least 6 months - Your average pain is at least 4 out of 10 on most days - You are on a stable pain treatment for at least 4 weeks - You carry a specific genetic variant (TSPO polymorphism) that allows accurate PET brain imaging — this is checked with a blood test **You may NOT be eligible if...** - You have had surgery within the past 1–2 months, or have not fully recovered - You have elevated liver enzyme levels - You have had interventional pain procedures (e.g., injections) within 6 weeks or plan them during the study - You have contraindications to PET/CT scanning Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCBD

Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. The drug is formulated from extracts prepared from Cannabis sativa L. plants that have a defined chemical profile and contain consistent levels of CBD as the principal phytocannabinoid. Extracts from these plants are processed to yield pure (\>95%) CBD that typically contains less than 0.5% (w/w) THC. Cannabidiol is the active ingredient in Epidiolex; inactive ingredients include dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose. Of note, CBD has no psychoactive properties.

OTHERPlacebo

Placebo CBD will be identical to the active CBD, a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring, but with no CBD.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT05066308


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