The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Opioid Use
研究概览
简要总结
This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will be a useful adjunct to opioid treatment in chronic neuropathic pain.
详细描述
This is an open-label study to evaluate the safety and efficacy of N-acetyl-L-cysteine in patients with Chronic neuropathic pain.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •non-cancer neuropathic pain
- •stable dose of opioids for pain
- •using breakthrough pain meds
- •still with persistent pain per VAS
排除标准
- •pregnant or nursing
- •serious medical or psychiatric illness (including uncontrolled hypertension)
- •active stomach ulcer, history or seizures or asthma
- •breakthrough pain meds other than opioids
- •using illicit drugs
研究组 & 干预措施
N-acetyl-L-cysteine
n-acetyl-l-cysteine 1200 mg BID x 4 weeks
干预措施: N-acetyl-l-cysteine (Drug)
结局指标
主要结局
Opioid Use
时间窗: Baseline, 4 weeks
The amount of opioid medication used was recorded. Then, it was converted to morphine equivalents (https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf). Opioid use was measured over a 2-week baseline period. Then, the average opioid medication use/week was calculated. This was compared to the average opioid medication use/week after 4 weeks of NAC.
次要结局
- Pain(Baseline, 4 weeks)
- Mood(Baseline, 4 weeks)
- Stress(Baseline, 4 weeks)