Clinical trial NCT03891264: Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain
Official title: Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Back Pain, Low
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 and ≤ 75;
* the ability to give written, informed consent;
* ongoing pain that averaged at least 4, on a 0-10 scale of pain during a typical week, and present for at least 50% of days during a typical week;
* fluency in English;
* on a stable pain treatment (pharmacological or otherwise) for the previous four weeks.
* Medical records confirming diagnosis of low back pain
* Chronic low back pain, ongoing for at least 6 months prior to enrollment.

Exclusion Criteria:

* outpatient surgery within 2 months and inpatient surgery within 6 months from the time of scanning;
* elevated baseline transaminase (ALT and AST) levels above 3 times the Upper Limit of Normal (ULN), accompanied by elevations in bilirubin above 2 times the ULN
* any interventional pain procedures within 6 weeks prior to scanning procedure or at any point during study enrollment;
* surgical intervention or introduction/change in opioid regimen at any point during study enrollment
* contraindications to functional magnetic resonance imaging scanning and positron emission tomography scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);
* current or past history within the last 5 years of major medical illness not affecting the central nervous system, other than chronic pain;
* implanted spinal cord stimulator (SCS) for pain treatment;
* any history of neurological illness or major medical illness affecting the central nervous system, unless clearly resolved without long-term consequences;
* current or past history of major psychiatric illness;
* PTSD, depression, and anxiety are exclusion criteria only if the conditions were so severe as to require hospitalization in the past year.
* pregnancy or breast feeding;
* history of head trauma requiring hospitalization;
* major cardiac event within the past 10 years;
* any use of recreational drugs in the past 3 months
* any marijuana use, medical or recreational, in the past 3 months
* an abnormal physical exam (e.g., peripheral edema);
* routine use of opioids ≥ 60 mg morphine equivalents;
* use of immunosuppressive medications, such as prednisone, TNF medications within 2 weeks of the visit;
* current bacterial or viral infection;
* Any other contraindications to CBD administration noted by the study physician.
* If undergoing blood draws through an arterial line during scan, contraindications to placement of arterial line, such as abnormal result on modified Allen's test on both hands; Raynaud syndrome; bleeding disorder; use of anticoagulants such as Coumadin, Plavix or Lovenox

Primary outcomes:
measure: Changes in Brain Positron Emission Tomography Signal
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours).
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jodi Gilman, PhD
role: PRINCIPAL_INVESTIGATOR
References: