Low Dose Naltrexone (LDN) Immune Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in IL-1β From Baseline.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Low Dose Naltrexone (Drug)
结局指标
主要结局
Change in IL-1β From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-4 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-5 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-6 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-7 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-8 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-9 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-10 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-12p40 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-12p70 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-13 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-15 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-17A From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-17F From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in RANTES From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-1α From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-1Ra From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-2 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-18 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-21 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-23 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-31 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-27 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in LIF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in G-CSF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in GM-CSF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIP-1α From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in SDF-1α From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IP-10 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Eotaxin From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIP-1β From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MCP-3 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TRAIL From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MCP-1 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIG From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in CD40L From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TGF-α From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TGF-β From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-α From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-β From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-γ From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TNF-α From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TNF-β From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PIGF-1 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VEGF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in FGF-β From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in SCF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in HGF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in EGF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in M-CSF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in BDNF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VCAM-1 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VEGF-D From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in NGF From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in ICAM-1 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in ENA-78 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PDGF-BB From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PAI-1 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Leptin From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Resistin From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in GROa From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in FaSL From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-22 From Baseline.
时间窗: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Pain From Baseline.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Jarred W. Younger
Associate Professor
University of Alabama at Birmingham