Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Pain Severity
研究概览
简要总结
The purpose of this study is to examine whether buprenorphine can be at least as effective as other opioid medications in relieving chronic pain in patients who suffer from dependence on their opioid medications, while patients simultaneously experience progressive decline of pain along with absence of opioid withdrawal symptoms and improved quality of life.
详细描述
The study will utilize sublingual buprenorphine for the treatment of chronic pain patients with co-occurring opioid dependence. Adult male and female chronic pain patients with co-occurring opioid dependence/disorder, being treated at MMC will be enrolled in a home induction procedure. Subjects will be switched from their current opioid pain medication to buprenorphine/naloxone to assess whether buprenorphine is at least as effective, if not more effective, as other opioid medications in controlling their pain while simultaneously improving their psychological distress, functional status, and other aspects of patients' lives. We will utilize a home induction procedure, and maintain subjects on this oral medication for a duration of 6 months.
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
- •Meets DSM criteria for opioid dependence (or opioid use disorder when DSM 5 is in use)
- •Has received opioid therapy for at least 90 days
- •Has opioid dependence as assessed by a Maimonides psychiatrist
排除标准
- •Scheduled for major surgery during study duration
- •Predicted life expectancy < 1 year
- •Plan to cease habitation in greater New York area within 6 months
- •Risks for buprenorphine outweigh potential benefit, as determined by the PI
- •Lacks sufficient fluency in English to understand the study protocol, answer survey questions or give informed consent
- •Pregnant women
结局指标
主要结局
Pain Severity
时间窗: 6 months
Pain severity will be measured using a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine), adopted from the Brief Pain Inventory (BPI). No results to report.
Opiate Withdrawal
时间窗: 6 months
Goal that patients will have NO withdrawal symptoms by the completion of their 3-day buprenorphine induction,and will remain withdrawal-free for the entire study duration. Assessed using Clinical Opiate Withdrawal Scale (COWS).
次要结局
- Quality of Life(6 months)
- Psychiatric Distress(6 months)
- Positive Affect(6 months)
研究者
Theresa Jacob, PhD, MPH
Director of Research
Maimonides Medical Center