The Use of Nomi Technology to Monitor Opioid Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- total nausea scale
研究概览
简要总结
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
详细描述
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. The participant will be asked to keep the medication in the bottle and to remove each pill immediately before taking it.
The participant will not store medications in pill organizers, other pill bottles, pockets, purses, etc. The participant will keep a record of when the participant removes a pill from the bottle and takes it. Certain aspects of this study will be withheld from the participant to preserve the integrity of the study. This information will be revealed at the conclusion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic pain > 3 months duration
- •major source of pain is due to low back pain diagnosis
- •prescribed only one type of opioid: hydrocodone 10mg/325 mg acetaminophen
- •Last urine drug study was done between 6-12 months ago
- •will have a return to clinic visit in 3 months
排除标准
- •concurrent use of other opioids
- •use of intrathecal device
- •use of spinal cord stimulator
- •presence of pain due to cancer, chemotherapy, radiation treatment and/or cancer related surgery
- •illiteracy
结局指标
主要结局
total nausea scale
时间窗: day 90
On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe
total medication dose
时间窗: day 90
pain medication dose (mg)
total vomiting scale
时间窗: day 90
On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe
total type of bowel movement
时间窗: day 90
choose one of the following: hard, soft, loose
total Pain scale
时间窗: day 90
On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt.
overall satisfaction with pain control
时间窗: day 90
0-10 scale where 0 is dissatisfied and 10 is very satisfied
total sedation scale
时间窗: day 90
On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe
total bowel movements
时间窗: day 90
number of bowel movements (whole number)
次要结局
- Barretts impulsivity questionnaire(day 90)
- opioid related behavior in treatment questionnaire(day 90)
- prescribed opioids difficulty scale(day 90)