Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 592 for:    cbd
Previous Study | Return to List | Next Study

Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain (CBD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891264
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Jodi Gilman, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Back Pain, Low Drug: Cannabidiol Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation of Cannabidiol for Reduction of NeuroInflammation
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: CBD Arm
Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 4-week trial of a liquid formulation of CBD.
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.
Other Name: Epidiolex




Primary Outcome Measures :
  1. Changes in brain PET signal [ Time Frame: 4 weeks ]
    The investigators will test for the presence of a significant treatment effect in the brain [11C]PBR28 signal.


Secondary Outcome Measures :
  1. Changes in pain outcomes as measured by self report on a 0-100 numerical pain rating scale. [ Time Frame: 4 weeks ]
    The investigators will test for the presence of a significant treatment effect in pain outcomes on a self reported numerical (0-100) pain rating scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891264


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jodi Gilman, PhD    617-643-7293    jgilman1@partners.org   
Principal Investigator: Jodi M Gilman, PhD         
Sponsors and Collaborators
Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Jodi Gilman, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03891264     History of Changes
Other Study ID Numbers: CBD_Pain_PET Trial
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will make this data available upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will become available after 2 years
Access Criteria: Researchers, not for commercial use

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Epidiolex
Anticonvulsants