Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in pain severity
研究概览
简要总结
The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of complex regional pain syndrome (CRPS). Study participants will be randomly assigned to receive either LDN or placebo for a period of several weeks. During this period participants will be asked to attend either in-person or virtual study visits and complete questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper and/or lower extremity CRPS
- •On stable treatment for 1 month
- •CRPS for at least 1 year
- •Meet the Budapest criteria for CRPS at time of the study.
排除标准
- •Any known allergy to naltrexone or naloxone
- •Use of prescription opioid analgesics or illegal opioid use
- •Current or planned pregnancy.
研究组 & 干预措施
LDN
Naltrexone HCL, 4.5 mg, Once a day.
干预措施: LDN (Drug)
Placebo
Sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in pain severity
时间窗: Approximately 4 weeks after conclusion of treatment.
Daily pain reports on a 0-10 numerical rating scale for pain, where 0=no pain and 10=pain as bad as you can imagine
次要结局
未报告次要终点
研究者
Sean Mackey
Redlich Professor Departments of Anesthesiology, Perioperative and Pain Medicine | Neurosciences | Neurology (by courtesy), Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab (SNAPL), Stanford University
Stanford University