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Low Dose Naltrexone (LDN) Immune Monitoring

Low Dose Naltrexone (LDN) Immune Monitoring

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02107014
Acronym
LDN-IM
Enrollment
9
Registered
2014-04-08
Start date
2014-03-31
Completion date
2014-07-31
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

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.

Detailed description

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.

Interventions

DRUGLow Dose Naltrexone

Naltrexone 4.5 mg p.o. nocte

Sponsors

Stanford University
CollaboratorOTHER
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in MCP-3 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in MIG From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in TRAIL From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-15 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-12p40 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-12p70 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-13 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-1α From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-1β From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-1Ra From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-2 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-4 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-5 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-6 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-7 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-8 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-9 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-10 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-17A From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-17F From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-18 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-21 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-23 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-31 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-27 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in LIF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in G-CSF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in GM-CSF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in MIP-1α From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in SDF-1α From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IP-10 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in Eotaxin From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in RANTES From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in MIP-1β From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in MCP-1 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in CD40L From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in TGF-α From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in TGF-β From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IFN-α From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IFN-β From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IFN-γ From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in TNF-α From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in TNF-β From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in PIGF-1 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in SCF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in HGF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in VEGF-D From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in VEGF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in NGF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in EGF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in FGF-β From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in M-CSF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in BDNF From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in ICAM-1 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in VCAM-1 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in ENA-78 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in PDGF-BB From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in PAI-1 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in Leptin From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in Resistin From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in GROa From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in FaSL From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in IL-22 From Baseline.Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].—
Change in Pain From Baseline.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.
Change in Overall Fibromyalgia Symptoms From Baseline.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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited Feb-April 2014 from a laboratory database of individuals with fibromyalgia who are interested in participating in research.

Participants by arm

ArmCount
Low Dose Naltrexone (LDN)
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period. Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
8
Total8

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrew before drug: moving interstate1

Baseline characteristics

CharacteristicLow Dose Naltrexone (LDN)
Age, Continuous46.3 years
STANDARD_DEVIATION 11.6
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
5 Participants
Region of Enrollment
United States
8 participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 8
serious
Total, serious adverse events
0 / 8

Outcome results

Primary

Change in BDNF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in BDNF From Baseline.BDNF baseline 2-weeks777.60 pg/mL
Low Dose Naltrexone (LDN)Change in BDNF From Baseline.BDNF last 2-weeks717.98 pg/mL
p-value: 0.945Mixed Models Analysis
Primary

Change in CD40L From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in CD40L From Baseline.CD40L baseline 2-weeks41.97 pg/mL
Low Dose Naltrexone (LDN)Change in CD40L From Baseline.CD40L last 2-weeks35.78 pg/mL
p-value: 0.201Mixed Models Analysis
Primary

Change in EGF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in EGF From Baseline.EGF baseline 2-weeks5.23 pg/mL
Low Dose Naltrexone (LDN)Change in EGF From Baseline.EGF last 2-weeks3.23 pg/mL
p-value: 0.639Mixed Models Analysis
Primary

Change in ENA-78 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in ENA-78 From Baseline.ENA-78 baseline 2-weeks134.64 pg/mL
Low Dose Naltrexone (LDN)Change in ENA-78 From Baseline.ENA-78 last 2-weeks83.36 pg/mL
p-value: 0.03Mixed Models Analysis
Primary

Change in Eotaxin From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in Eotaxin From Baseline.eotaxin baseline 2-weeks36.54 pg/mL
Low Dose Naltrexone (LDN)Change in Eotaxin From Baseline.eotaxin last 2-weeks29.95 pg/mL
p-value: 0.35Mixed Models Analysis
Primary

Change in FaSL From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in FaSL From Baseline.FaSL baseline 2-weeks0 pg/mL
Low Dose Naltrexone (LDN)Change in FaSL From Baseline.FaSL last 2-weeks0 pg/mL
Primary

Change in FGF-β From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in FGF-β From Baseline.FGF-β baseline 2-weeks0 pg/mL
Low Dose Naltrexone (LDN)Change in FGF-β From Baseline.FGF-β last 2-weeks0 pg/mL
Primary

Change in G-CSF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in G-CSF From Baseline.G-CSF baseline 2-weeks37.78 pg/mL
Low Dose Naltrexone (LDN)Change in G-CSF From Baseline.G-CSF last 2-weeks35.67 pg/mL
p-value: 0.012Mixed Models Analysis
Primary

Change in GM-CSF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in GM-CSF From Baseline.GM-CSF baseline 2-weeks5779.44 pg/mL
Low Dose Naltrexone (LDN)Change in GM-CSF From Baseline.GM-CSF last 2-weeks6377.62 pg/mL
p-value: 0.426Mixed Models Analysis
Primary

Change in GROa From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in GROa From Baseline.GROa baseline 2-weeks0 pg/mL
Low Dose Naltrexone (LDN)Change in GROa From Baseline.GROa last 2-weeks0 pg/mL
Primary

Change in HGF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in HGF From Baseline.HGF baseline 2-weeks187.27 pg/mL
Low Dose Naltrexone (LDN)Change in HGF From Baseline.HGF last 2-weeks189.33 pg/mL
p-value: 0.326Mixed Models Analysis
Primary

Change in ICAM-1 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in ICAM-1 From Baseline.ICAM-1 baseline 2-weeks2670.81 pg/mL
Low Dose Naltrexone (LDN)Change in ICAM-1 From Baseline.ICAM-1 last 2-weeks2820.63 pg/mL
p-value: 0.038Mixed Models Analysis
Primary

Change in IFN-α From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IFN-α From Baseline.IFN-α baseline 2-weeks4.99 pg/mL
Low Dose Naltrexone (LDN)Change in IFN-α From Baseline.IFN-α last 2-weeks4.15 pg/mL
p-value: 0.007Mixed Models Analysis
Primary

Change in IFN-β From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IFN-β From Baseline.IFN-β baseline 2-weeks24.04 pg/mL
Low Dose Naltrexone (LDN)Change in IFN-β From Baseline.IFN-β last 2-weeks19.10 pg/mL
p-value: 0.038Mixed Models Analysis
Primary

Change in IFN-γ From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IFN-γ From Baseline.IFN-γ baseline 2-weeks11.42 pg/mL
Low Dose Naltrexone (LDN)Change in IFN-γ From Baseline.IFN-γ last 2-weeks9.29 pg/mL
p-value: 0.032Mixed Models Analysis
Primary

Change in IL-10 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-10 From Baseline.IL-10 baseline 2-weeks6.01 pg/mL
Low Dose Naltrexone (LDN)Change in IL-10 From Baseline.IL-10 last 2-weeks10.11 pg/mL
p-value: 0.008Mixed Models Analysis
Primary

Change in IL-12p40 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-12p40 From Baseline.IL-12p40 baseline 2-weeks6.91 pg/mL
Low Dose Naltrexone (LDN)Change in IL-12p40 From Baseline.IL-12p40 last 2-weeks6.43 pg/mL
p-value: 0.004Mixed Models Analysis
Primary

Change in IL-12p70 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-12p70 From Baseline.IL-12p70 baseline 2-weeks1.82 pg/mL
Low Dose Naltrexone (LDN)Change in IL-12p70 From Baseline.IL-12p70 last 2-weeks1.69 pg/mL
p-value: <0.001Mixed Models Analysis
Primary

Change in IL-13 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-13 From Baseline.IL-13 baseline 2-weeks0.66 pg/mL
Low Dose Naltrexone (LDN)Change in IL-13 From Baseline.IL-13 last 2-weeks0.66 pg/mL
p-value: 0.047Mixed Models Analysis
Primary

Change in IL-15 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-15 From Baseline.IL-15 baseline 2-weeks11.08 pg/mL
Low Dose Naltrexone (LDN)Change in IL-15 From Baseline.IL-15 last 2-weeks8.71 pg/mL
p-value: 0.002Mixed Models Analysis
Primary

Change in IL-17A From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-17A From Baseline.IL-17A baseline 2-weeks5.03 pg/mL
Low Dose Naltrexone (LDN)Change in IL-17A From Baseline.IL-17A last 2-weeks3.40 pg/mL
p-value: 0.003Mixed Models Analysis
Primary

Change in IL-17F From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-17F From Baseline.IL-17F baseline 2-weeks0.95 pg/mL
Low Dose Naltrexone (LDN)Change in IL-17F From Baseline.IL-17F last 2-weeks0.89 pg/mL
p-value: 0.191Mixed Models Analysis
Primary

Change in IL-18 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-18 From Baseline.IL-18 baseline 2-weeks9.61 pg/mL
Low Dose Naltrexone (LDN)Change in IL-18 From Baseline.IL-18 last 2-weeks6.66 pg/mL
p-value: 0.088Mixed Models Analysis
Primary

Change in IL-1Ra From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-1Ra From Baseline.IL-1Ra baseline 2-weeks2433.11 pg/mL
Low Dose Naltrexone (LDN)Change in IL-1Ra From Baseline.IL-1Ra last 2-weeks2004.48 pg/mL
p-value: 0.008Mixed Models Analysis
Primary

Change in IL-1α From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-1α From Baseline.IL-1α baseline 2-weeks3.56 pg/mL
Low Dose Naltrexone (LDN)Change in IL-1α From Baseline.IL-1α last 2-weeks3.88 pg/mL
p-value: 0.576Mixed Models Analysis
Primary

Change in IL-1β From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-1β From Baseline.IL-1β baseline 2-weeks0.33 pg/mL
Low Dose Naltrexone (LDN)Change in IL-1β From Baseline.IL-1β last 2-weeks0.26 pg/mL
p-value: 0.01Mixed Models Analysis
Primary

Change in IL-21 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-21 From Baseline.IL-21 baseline 2-weeks29.96 pg/mL
Low Dose Naltrexone (LDN)Change in IL-21 From Baseline.IL-21 last 2-weeks327.07 pg/mL
p-value: 0.478Mixed Models Analysis
Primary

Change in IL-22 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-22 From Baseline.IL-22 baseline 2-weeks194.59 pg/mL
Low Dose Naltrexone (LDN)Change in IL-22 From Baseline.IL-22 last 2-weeks220.62 pg/mL
p-value: 0.967Mixed Models Analysis
Primary

Change in IL-23 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-23 From Baseline.IL-23 baseline 2-weeks0 pg/mL
Low Dose Naltrexone (LDN)Change in IL-23 From Baseline.IL-23 last 2-weeks0 pg/mL
Primary

Change in IL-27 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-27 From Baseline.IL-27 baseline 2-weeks86.51 pg/mL
Low Dose Naltrexone (LDN)Change in IL-27 From Baseline.IL-27 last 2-weeks96.39 pg/mL
p-value: 0.016Mixed Models Analysis
Primary

Change in IL-2 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-2 From Baseline.IL-2 baseline 2-weeks23.21 pg/mL
Low Dose Naltrexone (LDN)Change in IL-2 From Baseline.IL-2 last 2-weeks21.32 pg/mL
p-value: 0.015Mixed Models Analysis
Primary

Change in IL-31 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-31 From Baseline.IL-31 baseline 2-weeks0 pg/mL
Low Dose Naltrexone (LDN)Change in IL-31 From Baseline.IL-31 last 2-weeks0 pg/mL
Primary

Change in IL-4 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-4 From Baseline.IL-4 baseline 2-weeks20.70 pg/mL
Low Dose Naltrexone (LDN)Change in IL-4 From Baseline.IL-4 last 2-weeks19.00 pg/mL
p-value: 0.007Mixed Models Analysis
Primary

Change in IL-5 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-5 From Baseline.IL-5 baseline 2-weeks1.94 pg/mL
Low Dose Naltrexone (LDN)Change in IL-5 From Baseline.IL-5 last 2-weeks4.57 pg/mL
p-value: 0.016Mixed Models Analysis
Primary

Change in IL-6 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-6 From Baseline.IL-6 baseline 2-weeks10.22 pg/mL
Low Dose Naltrexone (LDN)Change in IL-6 From Baseline.IL-6 last 2-weeks5.87 pg/mL
p-value: <0.001Mixed Models Analysis
Primary

Change in IL-7 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-7 From Baseline.IL-7 baseline 2-weeks10.18 pg/mL
Low Dose Naltrexone (LDN)Change in IL-7 From Baseline.IL-7 last 2-weeks10.28 pg/mL
p-value: 0.212Mixed Models Analysis
Primary

Change in IL-8 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-8 From Baseline.IL-8 baseline 2-weeks0 pg/mL
Low Dose Naltrexone (LDN)Change in IL-8 From Baseline.IL-8 last 2-weeks0 pg/mL
Primary

Change in IL-9 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IL-9 From Baseline.IL-9 baseline 2-weeks0 pg/mL
Low Dose Naltrexone (LDN)Change in IL-9 From Baseline.IL-9 last 2-weeks0 pg/mL
Primary

Change in IP-10 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in IP-10 From Baseline.IP-10 baseline 2-weeks6.01 pg/mL
Low Dose Naltrexone (LDN)Change in IP-10 From Baseline.IP-10 last 2-weeks5.28 pg/mL
p-value: 0.558Mixed Models Analysis
Primary

Change in Leptin From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in Leptin From Baseline.leptin baseline 2-weeks3991.44 pg/mL
Low Dose Naltrexone (LDN)Change in Leptin From Baseline.leptin last 2-weeks4128.32 pg/mL
p-value: 0.893Mixed Models Analysis
Primary

Change in LIF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in LIF From Baseline.LIF baseline 2-weeks4.93 pg/mL
Low Dose Naltrexone (LDN)Change in LIF From Baseline.LIF last 2-weeks4.49 pg/mL
p-value: 0.025Mixed Models Analysis
Primary

Change in MCP-1 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in MCP-1 From Baseline.MCP-1 baseline 2-weeks24.30 pg/mL
Low Dose Naltrexone (LDN)Change in MCP-1 From Baseline.MCP-1 last 2-weeks25.38 pg/mL
p-value: 0.128Mixed Models Analysis
Primary

Change in MCP-3 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in MCP-3 From Baseline.MCP-3 baseline 2-weeks31.52 pg/mL
Low Dose Naltrexone (LDN)Change in MCP-3 From Baseline.MCP-3 last 2-weeks25.30 pg/mL
p-value: 0.065Mixed Models Analysis
Primary

Change in M-CSF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in M-CSF From Baseline.M-CSF baseline 2-weeks0 pg/mL
Low Dose Naltrexone (LDN)Change in M-CSF From Baseline.M-CSF last 2-weeks0 pg/mL
Primary

Change in MIG From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in MIG From Baseline.MIG baseline 2-weeks47.81 pg/mL
Low Dose Naltrexone (LDN)Change in MIG From Baseline.MIG last 2-weeks35.98 pg/mL
p-value: 0.962Mixed Models Analysis
Primary

Change in MIP-1α From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in MIP-1α From Baseline.MIP-1α baseline 2-weeks5.66 pg/mL
Low Dose Naltrexone (LDN)Change in MIP-1α From Baseline.MIP-1α last 2-weeks3.60 pg/mL
p-value: 0.042Mixed Models Analysis
Primary

Change in MIP-1β From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in MIP-1β From Baseline.MIP-1β baseline 2-weeks58.52 pg/mL
Low Dose Naltrexone (LDN)Change in MIP-1β From Baseline.MIP-1β last 2-weeks51.08 pg/mL
p-value: 0.248Mixed Models Analysis
Primary

Change in NGF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in NGF From Baseline.NGF baseline 2-weeks12.24 pg/mL
Low Dose Naltrexone (LDN)Change in NGF From Baseline.NGF last 2-weeks10.50 pg/mL
p-value: 0.08Mixed Models Analysis
Primary

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].

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose Naltrexone (LDN)Change in Overall Fibromyalgia Symptoms From Baseline.Overall symptoms baseline 2-weeks55.653 units on a scaleStandard Error 4.671
Low Dose Naltrexone (LDN)Change in Overall Fibromyalgia Symptoms From Baseline.Overall symptoms last 2-weeks45.506 units on a scaleStandard Error 4.633
p-value: <0.001Mixed Models Analysis
Primary

Change in PAI-1 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in PAI-1 From Baseline.PAI-1 baseline 2-weeks15086.40 pg/mL
Low Dose Naltrexone (LDN)Change in PAI-1 From Baseline.PAI-1 last 2-weeks15536.99 pg/mL
p-value: 0.61Mixed Models Analysis
Primary

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].

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose Naltrexone (LDN)Change in Pain From Baseline.Pain baseline 2-weeks51.149 units on a scaleStandard Error 4.841
Low Dose Naltrexone (LDN)Change in Pain From Baseline.Pain last 2-weeks43.286 units on a scaleStandard Error 4.805
p-value: <0.001Mixed Models Analysis
Primary

Change in PDGF-BB From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in PDGF-BB From Baseline.PDGF-BB baseline 2-weeks179.89 pg/mL
Low Dose Naltrexone (LDN)Change in PDGF-BB From Baseline.PDGF-BB last 2-weeks150.29 pg/mL
p-value: 0.948Mixed Models Analysis
Primary

Change in PIGF-1 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in PIGF-1 From Baseline.PIGF-1 baseline 2-weeks1.75 pg/mL
Low Dose Naltrexone (LDN)Change in PIGF-1 From Baseline.PIGF-1 last 2-weeks2.09 pg/mL
p-value: 0.508Mixed Models Analysis
Primary

Change in RANTES From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in RANTES From Baseline.RANTES baseline 2-weeks57.00 pg/mL
Low Dose Naltrexone (LDN)Change in RANTES From Baseline.RANTES last 2-weeks57.27 pg/mL
p-value: 0.655Mixed Models Analysis
Primary

Change in Resistin From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in Resistin From Baseline.Resistin last 2-weeks1942.47 pg/mL
Low Dose Naltrexone (LDN)Change in Resistin From Baseline.Resistin baseline 2-weeks1831.26 pg/mL
p-value: 0.041Mixed Models Analysis
Primary

Change in SCF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in SCF From Baseline.SCF baseline 2-weeks7.53 pg/mL
Low Dose Naltrexone (LDN)Change in SCF From Baseline.SCF last 2-weeks5.41 pg/mL
p-value: 0.119Mixed Models Analysis
Primary

Change in SDF-1α From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in SDF-1α From Baseline.SDF-1α baseline 2-weeks148.14 pg/mL
Low Dose Naltrexone (LDN)Change in SDF-1α From Baseline.SDF-1α last 2-weeks123.19 pg/mL
p-value: 0.708Mixed Models Analysis
Primary

Change in TGF-α From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in TGF-α From Baseline.TGF-α baseline 2-weeks1.42 pg/mL
Low Dose Naltrexone (LDN)Change in TGF-α From Baseline.TGF-α last 2-weeks0.58 pg/mL
p-value: 0.016Mixed Models Analysis
Primary

Change in TGF-β From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in TGF-β From Baseline.TGF-β baseline 2-weeks9.40 pg/mL
Low Dose Naltrexone (LDN)Change in TGF-β From Baseline.TGF-β last 2-weeks7.80 pg/mL
p-value: 0.006Mixed Models Analysis
Primary

Change in TNF-α From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in TNF-α From Baseline.TNF-α baseline 2-weeks124.36 pg/mL
Low Dose Naltrexone (LDN)Change in TNF-α From Baseline.TNF-α last 2-weeks116.04 pg/mL
p-value: 0.002Mixed Models Analysis
Primary

Change in TNF-β From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in TNF-β From Baseline.TNF-β baseline 2-weeks0 pg/mL
Low Dose Naltrexone (LDN)Change in TNF-β From Baseline.TNF-β last 2-weeks0 pg/mL
Primary

Change in TRAIL From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in TRAIL From Baseline.TRAIL baseline 2-weeks23.42 pg/mL
Low Dose Naltrexone (LDN)Change in TRAIL From Baseline.TRAIL last 2-weeks12.95 pg/mL
p-value: 0.402Mixed Models Analysis
Primary

Change in VCAM-1 From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in VCAM-1 From Baseline.VCAM-1 baseline 2-weeks30876.40 pg/mL
Low Dose Naltrexone (LDN)Change in VCAM-1 From Baseline.VCAM-1 last 2-weeks32156.99 pg/mL
p-value: 0.281Mixed Models Analysis
Primary

Change in VEGF-D From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in VEGF-D From Baseline.VEGF-D baseline 2-weeks2.62 pg/mL
Low Dose Naltrexone (LDN)Change in VEGF-D From Baseline.VEGF-D last 2-weeks3.30 pg/mL
p-value: 0.753Mixed Models Analysis
Primary

Change in VEGF From Baseline.

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

ArmMeasureGroupValue (MEDIAN)
Low Dose Naltrexone (LDN)Change in VEGF From Baseline.VEGF baseline 2-weeks80.95 pg/mL
Low Dose Naltrexone (LDN)Change in VEGF From Baseline.VEGF last 2-weeks70.70 pg/mL
p-value: 0.067Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026