Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain (CBD)
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|ClinicalTrials.gov Identifier: NCT03891264|
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : November 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Back Pain, Low||Drug: Cannabidiol||Phase 4|
The goal of this research study is to test whether "glial cells" (the immune cells of the brain and spinal cord) that are active in patients with low back pain can be reduced with CBD. Previous studies have showed that patients with chronic low back pain demonstrated elevations in brain levels of the 18kDa translocator protein (TSPO), a marker of glial activation.
To test this hypothesis, the study team will image the brains and spinal cords of patients suffering from low back pain using integrated magnetic resonance- positron emission tomography (MR-PET), and a radiotracer called [11C]PBR28, which tracks levels of glial activation.
The efficacy of CBD as a treatment for chronic low back pain will be evaluated. The study team will observe whether 4 weeks of CBD treatment may reduce glial activation along with self-reported low back pain symptoms. To this end, patients will be evaluated clinically and/or re-scanned after completing the 4-week trial of minocycline.
This study will be enrolling individuals who have been suffering from chronic low back pain.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Investigation of Cannabidiol for Reduction of NeuroInflammation|
|Actual Study Start Date :||November 19, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: CBD Arm
Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 4-week trial of a liquid formulation of CBD.
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. The recommended starting dosage is 2.5mg/kg taken twice daily (5mg/kg/day). After one week, the dosage will be increased to a maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). At the end of the first week, the patient will increase the dose to 10 mg/kg twice daily for the following week.
Other Name: Epidiolex
- Changes in brain PET signal [ Time Frame: 4 weeks ]The investigators will test for the presence of a significant treatment effect in the brain [11C]PBR28 signal.
- Changes in pain outcomes as measured by self report on a 0-100 numerical pain rating scale. [ Time Frame: 4 weeks ]The investigators will test for the presence of a significant treatment effect in pain outcomes on a self reported numerical (0-100) pain rating scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891264
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jodi Gilman, PhD 617-643-7293 firstname.lastname@example.org|
|Principal Investigator: Jodi M Gilman, PhD|