- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02107014
Low Dose Naltrexone (LDN) Immune Monitoring (LDN-IM)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Palo Alto, California, United States, 94304
- Stanford University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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Naltrexone 4.5 mg p.o. nocte
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in IL-1α From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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Change in IL-7 From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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Change in IL-9 From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
|
Change in IL-10 From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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Change in RANTES From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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Change in MIP-1β From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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Change in MCP-1 From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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Change in MCP-3 From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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Change in MIG From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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Change in TRAIL From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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].
|
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].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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Change in TGF-β From Baseline.
Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
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].
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
|
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.
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Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
|
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.
|
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29911
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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