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TerminatedNCT03891264CBDUpdated May 4, 2022Results posted

Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

A Phase 4 interventional study of Cannabidiol in Back Pain, Low, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-04.

Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Basic science

Why this study was terminated
Funding obtained to do a larger placebo-controlled trial
Phase
Phase 4
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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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.

Read the 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.

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Conditions studied

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In context

Neuroinflammatory Diseases

150 studies on the registry are indexed under Neuroinflammatory Diseases; 70 are open to participants now.

This study's enrollment of 7 is below the median of 44 across 91 interventional studies indexed under Neuroinflammatory Diseases.

Browse Neuroinflammatory Diseases studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • 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

Interventions

  • DrugCannabidiol

    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

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What researchers measure

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.

    Time frame: 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).

    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.

    Time frame: 4 weeks

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Results

Posted Apr 13, 2022

Participant flow

Participant flow — Overall Study
MilestoneCBD Arm
Started7
Received intervention3
Completed2
Not completed5
Withdrew: Adverse event1
Withdrew: Withdrawal by subject2
Withdrew: Physician decision2

Outcome measures

PrimaryChanges in Brain Positron Emission Tomography Signal

The investigators will test for the presence of a significant treatment effect in the brain \[11C\]PBR28 signal.

Time frame:
4 weeks
Reported as:
Mean · Standardized Uptake Values (SUVs)
Changes in Brain Positron Emission Tomography Signal
Standardized Uptake Values (SUVs)CBD Arm
Changes in Brain Positron Emission Tomography Signal0.00197 ± 0.017756865
SecondaryChanges 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.

Time frame:
4 weeks
Reported as:
Mean · score on a scale
Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours).
score on a scaleCBD Arm
Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours).4.5 ± 0.707106781

Adverse events

Collected over From enrollment to 2 weeks following study medication discontinuation (6 weeks). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CBD Arm0/3 (0%)0/3 (0%)1/3 (33.3%)
Most frequent other events
Most frequent other events
EventCBD Arm
RashSkin and subcutaneous tissue disorders1/3

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)CBD Arm
<=18 years0
Between 18 and 65 years2
>=65 years1
Age, Continuous
Age, Continuous(years)CBD Arm
Mean62.5 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)CBD Arm
Female2
Male1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CBD Arm
Hispanic or Latino1
Not Hispanic or Latino2
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CBD Arm
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White2
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)CBD Arm
United States3
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Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 12, 2020
  • Informed consent form · Nov 12, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — We will make this data available upon request

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03891264
Lead sponsor
Massachusetts General Hospital
Responsible party
Jodi Gilman (Associate Professor, Massachusetts General Hospital) — Principal investigator
First posted
Mar 27, 2019
Start date
Nov 13, 2019
Primary completion
Nov 23, 2020
Completion
Nov 23, 2020
Results posted
Apr 13, 2022
Last update
May 4, 2022

Study contacts

Jodi Gilman, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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