Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain
Condition: Back Pain, Low
MeSH terms: Neuroinflammatory Diseases; Back Pain; Low Back Pain
Intervention: Cannabidiol
Intervention description: 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.
Intervention MeSH terms: Cannabidiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

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