Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

Last updated: April 12, 2022
Sponsor: Massachusetts General Hospital
Overall Status: Terminated

Phase

4

Condition

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT03891264
2019P000852
  • Ages 18-75
  • All Genders

Study 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

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

Exclusion Criteria:

  • outpatient surgery within 2 months and inpatient surgery within 6 months from the timeof scanning;
  • elevated baseline transaminase (ALT and AST) levels above 3 times the Upper Limit ofNormal (ULN), accompanied by elevations in bilirubin above 2 times the ULN
  • any interventional pain procedures within 6 weeks prior to scanning procedure or atany point during study enrollment;
  • surgical intervention or introduction/change in opioid regimen at any point duringstudy enrollment
  • contraindications to functional magnetic resonance imaging scanning and positronemission tomography scanning (including presence of a cardiac pacemaker or pacemakerwires, metallic particles in the body, vascular clips in the head or previousneurosurgery, prosthetic heart valves, claustrophobia);
  • current or past history within the last 5 years of major medical illness not affectingthe 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 centralnervous 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 sosevere 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 2weeks 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 toplacement of arterial line, such as abnormal result on modified Allen's test on bothhands; Raynaud syndrome; bleeding disorder; use of anticoagulants such as Coumadin,Plavix or Lovenox

Study Design

Total Participants: 7
Study Start date:
November 13, 2019
Estimated Completion Date:
November 23, 2020

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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