Low Dose Naltrexone in the Treatment of Central Neuropathic Pain After Traumatic Spinal Cord Injury: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluate LDN in the treatment of CNP after SCI
研究概览
简要总结
The goal of this pilot clinical trial is to find out how well low dose naltrexone works for people with pain due to spinal cord injury. The main questions it aims to answer are: will low dose naltrexone reduce pain, and increase the quality of life for people with central neuropathic pain due to spinal cord injury.
Hypothesis 1: LDN will decrease the severity of CNP in adult patients with SCI as measured by the Neuropathic Pain Scale (NPS) Hypothesis 2: LDN will improve quality of life of patients with SCI as measured by various validated clinical tools
There is no comparison group. This study is being completed to give investigators more information for how to best run a larger clinical trial.
Participants will be asked to take an oral dose of 4.5mg of naltrexone, daily, for 12 weeks.
详细描述
This study is being completed to provide the first evidence that low dose naltrexone may be able to lower pain and improve quality of life for people with pain due to spinal cord injury. Data from this study will be used to plan a larger, randomized control trial. If eligible, participants will take a daily low dose naltrexone pill (4.5mg) by mouth for 12 weeks. Study participants will keep a daily medicine log and a daily sleep log. The study team will check in regularly (virtual visits) with the participants and give questionnaires verbally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a traumatic cervical or thoracic spinal cord injury
- •>6 months from time of injury
- •Central neuropathic pain related to SCI, based on evaluation of a Physical Medicine & Rehabilitation Physician
- •DN4 questionnaire ≥ 4
- •English speaking
排除标准
- •Adjustment in pain medications within the previous month
- •Chronic opioid treatment
- •Current treatment with naltrexone or other opioid antagonist
- •Allergy to naltrexone
- •Central neuropathic pain attributed to other etiology
- •Neuropathic pain attributed to the peripheral nervous system
- •PHQ9 ≥15 indicating moderately severe or severe depressive symptoms
- •Documented traumatic brain injury that would affect study participation, in the opinion of the investigator
- •Scheduled elective surgery during the duration of the study
- •Pregnant or breastfeeding
- •Illicit substance use per Wisconsin law
研究组 & 干预措施
Low Dose Naltrexone
Daily dose of 4.5mg of naltrexone
干预措施: 4.5mg daily dose of naltrexone (Drug)
结局指标
主要结局
Evaluate LDN in the treatment of CNP after SCI
时间窗: From enrollment to the end of treatment at 12 weeks
Generate initial data to calculate an effect size of LDN in the treatment of CNP in SCI. This will be utilized to plan a randomized control trial and submit for extramural funding.
次要结局
- Evaluate improvement in quality of life using the Patient Global Impression of Change (PGIC)(From enrollment to the end of treatment at 12 weeks)
- Evaluate improvement in quality of life using the Neuropathic Pain Scale (NPS).(From enrollment to the end of treatment at 12 weeks)
- Evaluate improvement in quality of life using the Average Daily Pain Score (ADPS).(From enrollment to the end of treatment at 12 weeks)
- Evaluate improvement in quality of life using Daily Sleep Interference Scale (DSIS)(From enrollment to the end of treatment at 12 weeks)
- Evaluate improvement in quality of life using the Spinal Cord Injury Quality of Life Pain Interference Scale (SCI-QOL).(From enrollment to the end of treatment at 12 weeks)
研究者
Chen Cui
Assistant Professor
Medical College of Wisconsin