Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

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.

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 fMRI scanning and PET 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