Dose Reduction Strategies in Oral Opioid Dependence Subsequent to Pain Management: An Exploratory Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Substance use
研究概览
简要总结
Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is to determine the effectiveness of buprenorphine in treating opioid dependent individuals who abuse opioids that are prescribed for chronic pain.
详细描述
Many individuals who take opioids for chronic pain abuse the opioid medication. Buprenorphine is an opioid partial agonist that may be effective in treating individuals who abuse opiate pain medication. The purpose of this study is to compare two buprenorphine dosing regimens in order to determine which regimen is more effective in reducing opiate pain medication use and facilitating successful opioid detoxification.
This study will last 27 weeks. Participants will receive a maintenance dose of 8 mg of buprenorphine for 6 weeks, followed by a dose reduction in 2 mg increments over the course of the following 20 weeks. All participants will attend weekly clinical management sessions for the duration 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current opioid analgesic dependence
- •History of at least 2 years of oral opiate analgesic use
- •Prescribed opioids for chronic pain
- •Pain episode of at least 6 months duration within the 5 years prior to study entry
- •Available for the duration of the study
- •Good general health
排除标准
- •Currently using any illicit substance
- •Meets criteria for alcohol dependence
- •History of heroin use
- •History of opiate replacement therapy, including Levo-Alpha Acetyl Methadol (LAAM) or methadone
- •Evidence of current maximal primary pain
结局指标
主要结局
Substance use
medication compliance
treatment retention
次要结局
- Behavioral and psychological measures (measured during the dose reduction phase)