NCT03106740

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. The efficacy of minocycline use for low back pain treatment will also be evaluated by observing whether short-term minocycline administration will reduce neuroinflammation and low back pain symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_2 low-back-pain

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_2 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 10, 2017

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 11, 2025

Completed
Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

6.6 years

First QC Date

March 28, 2017

Results QC Date

February 5, 2025

Last Update Submit

February 9, 2026

Conditions

Pain, ChronicLow Back PainBack Pain With RadiationBack Pain Without RadiationBack Pain Lower Back ChronicBack Ache

Keywords

MicrogliaMinocyclineMagnetic Resonance ImagingPositron Emission TomographyPainAstrocytesGliaHumanBack Pain

Outcome Measures

Primary Outcomes (1)

  • Changes in Thalamic Standardized Uptake Value Ratio (SUVR)

    The ratio of the standardized uptake value (SUV; mean radioactivity divided by the injected dose by weight) of the whole thalamus divided by the SUV of the whole brain (i.e., standardized uptake value ratio or SUVR) derived from the translocator protein positron emission tomography (TSPO-PET) signal. Higher SUVR might be indicative of higher neuroinflammation.

    The outcome measure was assessed in two time points, before and after a two-week treatment period.

Secondary Outcomes (2)

  • Changes in Spinal PET Signal

    2 weeks

  • Rate of Change in Daily Modified Brief Pain Inventory (BPI) Severity Subscale

    2 weeks

Study Arms (2)

Minocycline Arm

EXPERIMENTAL

Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 2-week trial of Minocycline Hydrochloride, 100mg capsule

Drug: Minocycline Hydrochloride 100mg CapsuleDiagnostic Test: Magnetic Resonance-Positron Emission Tomography Imaging

Placebo Arm

PLACEBO COMPARATOR

Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after 2 weeks of treatment with a placebo capsule.

Diagnostic Test: Magnetic Resonance-Positron Emission Tomography ImagingOther: Placebo Capsule

Interventions

Magnetic Resonance-Positron Emission Tomography ImagingDIAGNOSTIC_TEST

Up to 15 millicuries of \[11C\]PBR28 will be administered to each subject at each imaging visit, for a maximum of 2 imaging visits.

Minocycline ArmPlacebo Arm
Minocycline Hydrochloride 100mg CapsuleDRUG

Minocycline 100mg will be administered by mouth daily for 2 weeks

Also known as: Minocin, Solodyn, Dynacin, Myrac
Minocycline Arm
Placebo CapsuleOTHER

1 Placebo Capsule (compounded with lactose powder) will be administered by mouth daily for 2 weeks

Placebo Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the ability to give written informed consent
  • fluency in English
  • on a stable pain treatment
  • Chronic or sub-acute low back pain

You may not qualify if:

  • no interventional pain procedures during drug trial
  • contraindications to MRI 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)
  • pregnancy or breast feeding
  • any use of recreational drugs in the past 6 months
  • allergy to minocycline or other tetracyclines, or taking medications known to interact with minocycline
  • any other contraindications to minocycline administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (4)

  • Loggia ML, Chonde DB, Akeju O, Arabasz G, Catana C, Edwards RR, Hill E, Hsu S, Izquierdo-Garcia D, Ji RR, Riley M, Wasan AD, Zurcher NR, Albrecht DS, Vangel MG, Rosen BR, Napadow V, Hooker JM. Evidence for brain glial activation in chronic pain patients. Brain. 2015 Mar;138(Pt 3):604-15. doi: 10.1093/brain/awu377. Epub 2015 Jan 12.

    PMID: 25582579BACKGROUND

  • Vanelderen P, Van Zundert J, Kozicz T, Puylaert M, De Vooght P, Mestrum R, Heylen R, Roubos E, Vissers K. Effect of minocycline on lumbar radicular neuropathic pain: a randomized, placebo-controlled, double-blind clinical trial with amitriptyline as a comparator. Anesthesiology. 2015 Feb;122(2):399-406. doi: 10.1097/ALN.0000000000000508.

    PMID: 25373391BACKGROUND

  • Mohammadian M, Morrissey EJ, Knight PC, Brusaferri L, Kim M, Efthimiou N, Murphy JP, Alshelh Z, Grmek G, Schnieders JH, Chane CA, Sandstrom A, Catana C, Gilman JM, Locascio JJ, Edwards RR, Zhang Y, Napadow V, Loggia ML. Investigating the potential of minocycline in reducing brain inflammation in chronic low back pain: a randomized, placebo-controlled mechanistic clinical trial. Pain. 2025 Apr 9;166(9):2044-2053. doi: 10.1097/j.pain.0000000000003543.

    PMID: 40839604DERIVED

  • Morrissey EJ, Alshelh Z, Knight PC, Saha A, Kim M, Torrado-Carvajal A, Zhang Y, Edwards RR, Pike C, Locascio JJ, Napadow V, Loggia ML. Assessing the potential anti-neuroinflammatory effect of minocycline in chronic low back pain: Protocol for a randomized, double-blind, placebo-controlled trial. Contemp Clin Trials. 2023 Mar;126:107087. doi: 10.1016/j.cct.2023.107087. Epub 2023 Jan 16.

    PMID: 36657520DERIVED

MeSH Terms

Conditions

Low Back PainBack PainChronic Paincyclopia sequencePain

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Marco Loggia
Organization
Massachusetts General Hospital
marco.loggia@mgh.harvard.edu
(617) 643-7267

Study Officials

  • Marco L Loggia, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Radiology and Anesthesiology

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 10, 2017

Study Start

October 10, 2017

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

February 11, 2026

Results First Posted

May 11, 2025

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)