Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

NCT03891264 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2019P000852
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain, Low

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours).

  4 weeks

Study Arms (1)

CBD Arm

EXPERIMENTAL

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

Interventions

Cannabidiol DRUG

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.

Also known as: Epidiolex

CBD Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Jodi Gilman
• Organization: Massachusetts General Hospital

jgilman1@partners.org

617-643-7293

Study Officials

• Jodi Gilman, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: November 13, 2019
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: May 4, 2022
• Results First Posted: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after 2 years
• Access Criteria: Researchers, not for commercial use

Locations

US (1)