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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
9
Naltrexone 4.5 mg p.o. nocte
Stanford University School of Medicine
Palo Alto, California, United States
Change in IL-1α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-1β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-1Ra From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-2 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-4 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-5 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-6 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-7 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-8 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-9 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
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Change in IL-10 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-12p40 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-12p70 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-13 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-15 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-17A From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-17F From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-18 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-21 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-23 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-31 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-27 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in LIF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in G-CSF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in GM-CSF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIP-1α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in SDF-1α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IP-10 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Eotaxin From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in RANTES From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIP-1β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MCP-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MCP-3 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIG From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TRAIL From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in CD40L From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TGF-α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TGF-β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-γ From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TNF-α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TNF-β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PIGF-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in SCF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in HGF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VEGF-D From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VEGF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in NGF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in EGF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in FGF-β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in M-CSF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in BDNF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in ICAM-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VCAM-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in ENA-78 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PDGF-BB From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PAI-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Leptin From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Resistin From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in GROa From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in FaSL From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-22 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Pain From Baseline.
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.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Overall Fibromyalgia Symptoms From Baseline.
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.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].