Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 191 for:    epidiolex

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 : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Jodi Gilman, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE March 27, 2019
Last Update Posted Date March 29, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
Glial activation [ Time Frame: 4 weeks ]
Brain levels of the 18kDa translocator protein (TSPO)
Change History Complete list of historical versions of study NCT03891264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
Pain Scores [ Time Frame: 4 weeks ]
PCS Pain Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain
Official Title  ICMJE Investigation of Cannabidiol for Reduction of NeuroInflammation
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Back Pain, Low
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Cannabidiol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03891264
Other Study ID Numbers  ICMJE CBD_Pain_PET Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We will make this data available upon request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data will become available after 2 years
Access Criteria: Researchers, not for commercial use
Responsible Party Jodi Gilman, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP