Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

Back Pain, Low Clinical Trial

— CBD  

Official title:

Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03891264
• Other study ID #: 2019P000852
• Status: Terminated
• Phase: Phase 4
• Start date: November 13, 2019
• Est. completion date: November 23, 2020

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain, Low
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	4 weeks