A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Number of Participants Retained in Treatment
研究概览
简要总结
The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.
详细描述
The purpose of this randomized clinical trial is to compare methadone with buprenorphine for the treatment of chronic pain among patients who have developed a physical dependence on prescription opiate analgesics that is associated with psychosocial dysfunction (i.e., addiction).
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
- 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
- 是
入选标准
- •chronic back pain
- •opioid addiction
- •not successful with abstinence
- •at least 18 years old
- •able to understand spoken English
- •live in Western New York State (Erie or Niagara county)
- •have health insurance or ability to pay for health care
- •no methadone or buprenorphine treatment within past year
- •not member of a vulnerable population (e.g., pregnancy, prisoner)
排除标准
- •homelessness
- •unable to give consent (e.g., dementia, psychosis)
- •serious heart or lung disease
- •taking a medication that could interact with methadone or buprenorphine
- •pregnancy
研究组 & 干预措施
1
Methadone 10-60 mg per day in 2-4 divided doses for 6 months
干预措施: Methadone (Drug)
2
Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
干预措施: Buprenorphine/naloxone (Drug)
结局指标
主要结局
Number of Participants Retained in Treatment
时间窗: 6 months
This outcome assesses the number of participants who completed the treatment after 6 months.
次要结局
- Numerical Rating Score for Pain(6 months)
- Numerical Rating Score for Functioning(6 months)
- Self-reported Illicit Opioid Use(6 months)
研究者
Richard Blondell
MD
State University of New York at Buffalo