Clinical trial NCT02107014: Low Dose Naltrexone (LDN) Immune Monitoring
Official title: Low Dose Naltrexone (LDN) Immune Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2014-04-08
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in IL-1α From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-1β From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-1Ra From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-2 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-4 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-5 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-6 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-7 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-8 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-9 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-10 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-12p40 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-12p70 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-13 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-15 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-17A From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-17F From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-18 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-21 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-23 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-31 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-27 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in LIF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in G-CSF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in GM-CSF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in MIP-1α From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in SDF-1α From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IP-10 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in Eotaxin From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in RANTES From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in MIP-1β From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in MCP-1 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in MCP-3 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in MIG From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in TRAIL From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in CD40L From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in TGF-α From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in TGF-β From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IFN-α From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IFN-β From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IFN-γ From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in TNF-α From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in TNF-β From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in PIGF-1 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in SCF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in HGF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in VEGF-D From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in VEGF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in NGF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in EGF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in FGF-β From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in M-CSF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in BDNF From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in ICAM-1 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in VCAM-1 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in ENA-78 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in PDGF-BB From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in PAI-1 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in Leptin From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in Resistin From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in GROa From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in FaSL From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in IL-22 From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in Pain From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
measure: Change in Overall Fibromyalgia Symptoms From Baseline.
timeFrame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: University of Alabama at Birmingham
name: Jarred Younger, PhD
role: PRINCIPAL_INVESTIGATOR
References: