Effects of Low Dose Naltrexone in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
研究概览
简要总结
Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems. In this study, we will administer both LDN and placebo to a small group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom Illnesses, to assess the drug's efficacy in treating the condition.
详细描述
This study will be a placebo-controlled, double-blind, cross-over drug tria. Patients with Primary Fibromyalgia or Gulf War Syndrome will be recruited from the Stanford University Pain Management Center and the surrounding community. Participation in the study will cover 22 weeks. Participants will attend a laboratory session 12 times for progress checkups, and will complete daily measures of symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently suffering from moderate to severe Fibromyalgia or symptoms of Gulf War Syndrome Age 18-
- •Not taking any opioid analgesic Not pregnant or planning to become pregnant.
排除标准
- •Any known allergy to naltrexone or naloxone. Actual or planned pregnancy.
研究组 & 干预措施
Low Dose Naltrexone first
LDN first, then placebo.
干预措施: Low Dose Naltrexone (Drug)
Low Dose Naltrexone first
LDN first, then placebo.
干预措施: Placebo - sugar pill (Drug)
Placebo - sugar pill first
Placebo first, then LDN.
干预措施: Low Dose Naltrexone (Drug)
Placebo - sugar pill first
Placebo first, then LDN.
干预措施: Placebo - sugar pill (Drug)
结局指标
主要结局
Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
时间窗: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)
Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable. Baseline pain calculated averaging daily pain scores over the 2 week baseline period. Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition. Values were converted to percent change in pain: \[(baseline pain - end point pain)/baseline pain\] x 100.
次要结局
- Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.(Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks))
- Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.(Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks))
- Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.(Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks))
- Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.(Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks))
研究者
Sean Mackey
Associate Professor
Stanford University