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NCT03891264: CBD

Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

Terminated Phase 4 Results posted Last updated 4 May 2022
What this trial tests

Phase 4 trial testing Cannabidiol in Back Pain, Low in 7 participants. Terminated before completion.

Timeline
13 November 2019
Primary endpoint
23 November 2020
23 November 2020

Quick facts

Lead sponsorMassachusetts General Hospital
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment7
Start date13 November 2019
Primary completion23 November 2020
Estimated completion23 November 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 75, any sex, with Back Pain, Low. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Brain Positron Emission Tomography Signal Primary · 4 weeks

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

GroupValue95% CI
CBD Arm0.00197± 0.017756865
Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours). Secondary · 4 weeks

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.

GroupValue95% CI
CBD Arm4.5± 0.707106781

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment to 2 weeks following study medication discontinuation (6 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CBD Arm
Serious: 0/3 (0%)
Deaths: 0/3
Other adverse events (1 terms — click to expand)

ReactionSystemCBD Arm
RashSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT03891264 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cannabinoid Formulations and Delivery Systems: Current and Future Options to Treat Pain.
    Stella B, Baratta F, Della Pepa C, Arpicco S, et al · · 2021 · cited 103× · PMID 34480749 · DOI 10.1007/s40265-021-01579-x
  2. Cannabinoids, Inner Ear, Hearing, and Tinnitus: A Neuroimmunological Perspective.
    Perin P, Mabou Tagne A, Enrico P, Marino F, et al · · 2020 · cited 8× · PMID 33329293 · DOI 10.3389/fneur.2020.505995
  3. FAAH Modulators from Natural Sources: A Collection of New Potential Drugs.
    Nicoara C, Fezza F, Maccarrone M. · · 2025 · cited 4× · PMID 40214504 · DOI 10.3390/cells14070551

Verify or expand the search:

Other trials of Cannabidiol

Trials testing the same drug.

Other recruiting trials for Back Pain, Low

Currently open trials in the same condition.

Other Massachusetts General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03891264.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing