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Completed

NCT Number: NCT02107014

Low Dose Naltrexone (LDN) Immune Monitoring

We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

About this study

Eligible women with Fibromyalgia (FM) will be enrolled into a 10-week drug trial. During the first two weeks, a baseline phase will be used to collect data on immune function and symptoms. LDN will be administered for 8 weeks. Although there is no placebo arm built-in, participants will be advised that they may receive a placebo during the trial. Participants will provide twice daily symptom reports using an android tablet device and Dooblo SurveyToGo survey software. Participants will also provide a blood sample twice every week for the duration of the study. Plasma inflammatory markers will be tested using a luminex based 63-plex inflammatory assay panel.

The primary aim of the study is to test if 8 weeks of LDN administration is associated with a reduction in pro-inflammatory markers in plasma in women with FM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females age 18-65
  • Meets criteria for 1990 ACR criteria for fibromyalgia
  • Able to receive venous blood draw twice a week for 16 weeks
  • Sufficient symptom variability during baseline report
  • Patient completes daily report during 2 week baseline period at least 80% completion rate.

Exclusion criteria

  • Opioid use
  • Significant psychological comorbidity that in the discretion of the investigator compromises study integrity
  • Location prohibits travel to Stanford
  • Blood or clotting disorder
  • Rheumatologic or autoimmune disease
  • Acute infection
  • Baseline blood ESR >60, CRP greater than 3.0mg/L, positive rheumatoid factor, or positive ANA
  • Use of blood thinning medication
  • Pregnant or currently planning to become pregnant
  • Current use of aspirin, ibuprofen, naproxen, or other confounding-anti-inflammatory medication as part of regular medication regimen.
  • Known allergy to Naltrexone or Naloxone
  • Currently participating in another treatment-based research study
  • Self-reported inability to refrain from alcohol for the duration of the study period

Treatment and study plan

Low Dose Naltrexone

Drug

Naltrexone 4.5 mg p.o. nocte

Other names: LDN, Naltrexone

Primary outcomes

  1. Change in IL-1α From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  2. Change in IL-1β From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  3. Change in IL-1Ra From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  4. Change in IL-2 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  5. Change in IL-4 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  6. Change in IL-5 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  7. Change in IL-6 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  8. Change in IL-7 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  9. Change in IL-8 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  10. Change in IL-9 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  11. Change in IL-10 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  12. Change in IL-12p40 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  13. Change in IL-12p70 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  14. Change in IL-13 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  15. Change in IL-15 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  16. Change in IL-17A From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  17. Change in IL-17F From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  18. Change in IL-18 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  19. Change in IL-21 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  20. Change in IL-23 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  21. Change in IL-31 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  22. Change in IL-27 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  23. Change in LIF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  24. Change in G-CSF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  25. Change in GM-CSF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  26. Change in MIP-1α From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  27. Change in SDF-1α From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  28. Change in IP-10 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  29. Change in Eotaxin From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  30. Change in RANTES From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  31. Change in MIP-1β From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  32. Change in MCP-1 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  33. Change in MCP-3 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  34. Change in MIG From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  35. Change in TRAIL From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  36. Change in CD40L From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  37. Change in TGF-α From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  38. Change in TGF-β From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  39. Change in IFN-α From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  40. Change in IFN-β From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  41. Change in IFN-γ From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  42. Change in TNF-α From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  43. Change in TNF-β From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  44. Change in PIGF-1 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  45. Change in SCF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  46. Change in HGF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  47. Change in VEGF-D From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  48. Change in VEGF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  49. Change in NGF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  50. Change in EGF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  51. Change in FGF-β From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  52. Change in M-CSF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  53. Change in BDNF From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  54. Change in ICAM-1 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  55. Change in VCAM-1 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  56. Change in ENA-78 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  57. Change in PDGF-BB From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  58. Change in PAI-1 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  59. Change in Leptin From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  60. Change in Resistin From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  61. Change in GROa From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  62. Change in FaSL From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  63. Change in IL-22 From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

  64. Change in Pain From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

    Visual analog scale (0-100) anchored at "no pain" at 0 and "worst possible pain" at 100. Improvement in pain would be indicated by a decrease in the score.

  65. Change in Overall Fibromyalgia Symptoms From Baseline.

    Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

    Visual analog scale (0-100) anchored at "no symptoms" at 0 and "worst possible symptoms" at 100. Improvement in overall fibromyalgia symptoms would be indicated by a decrease in the score.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Stanford University

Registry information

Acronym: LDN-IM

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2014
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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