A Phase 4 interventional study of Cannabidiol in Back Pain, Low, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Basic science
In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain, and whether CBD effects levels of neuroinflammation. The efficacy of CBD use for low back pain treatment will also be evaluated by observing whether CBD administration will reduce neuroinflammation and low back pain symptoms.
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.
150 studies on the registry are indexed under Neuroinflammatory Diseases; 70 are open to participants now.
This study's enrollment of 7 is below the median of 44 across 91 interventional studies indexed under Neuroinflammatory Diseases.
Browse Neuroinflammatory Diseases studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Cannabidiol
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.
Also known as: Epidiolex
Changes in Brain Positron Emission Tomography Signal
The investigators will test for the presence of a significant treatment effect in the brain \[11C\]PBR28 signal.
Time frame: 4 weeks
Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours).
The investigators will test for the presence of a significant treatment effect in pain outcomes on a self reported numerical (0-10) pain rating scale. Higher number indicates worse pain.
Time frame: 4 weeks
| Milestone | CBD Arm |
|---|---|
| Started | 7 |
| Received intervention | 3 |
| Completed | 2 |
| Not completed | 5 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Physician decision | 2 |
The investigators will test for the presence of a significant treatment effect in the brain \[11C\]PBR28 signal.
| Standardized Uptake Values (SUVs) | CBD Arm |
|---|---|
| Changes in Brain Positron Emission Tomography Signal | 0.00197 ± 0.017756865 |
The investigators will test for the presence of a significant treatment effect in pain outcomes on a self reported numerical (0-10) pain rating scale. Higher number indicates worse pain.
| score on a scale | CBD Arm |
|---|---|
| Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours). | 4.5 ± 0.707106781 |
Collected over From enrollment to 2 weeks following study medication discontinuation (6 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBD Arm | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Event | CBD Arm |
|---|---|
| RashSkin and subcutaneous tissue disorders | 1/3 |
| Age, Categorical(Participants) | CBD Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 1 |
| Age, Continuous(years) | CBD Arm |
|---|---|
| Mean | 62.5 ± 11 |
| Sex: Female, Male(Participants) | CBD Arm |
|---|---|
| Female | 2 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | CBD Arm |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | CBD Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | CBD Arm |
|---|---|
| United States | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We will make this data available upon request
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital