A Randomized Controlled Trial Testing Buprenorphine as a Treatment in Opiate Dependent Pain Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Relapse to Substance Abuse
研究概览
简要总结
This study is designed to determine if different doses of buprenorphine (either tapering doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines.
详细描述
Context: Some individuals have two conditions: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. It is not known how to manage these patients. In addition to other modalities for the treatment of chronic pain, combination tablets of buprenorphine/naloxone (Suboxone) may be helpful.
Objective: The objective of this study is to determine if the addition of pharmacotherapy with Suboxone to usual care would improve clinical outcome relative to usual care alone.
Design: Randomized control trial.
Setting: The study will be conducted in the out-patient clinics of a tertiary-care teaching hospital.
Participants: The participants will be those who have: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency.
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
- 否
入选标准
- •Clinical diagnosis of chronic refractory pain
- •Clinical diagnosis of opiate dependency
排除标准
- •unable to pay for medication
- •enrolled in a methadone maintenance program
- •homelessness
- •major mental illness
- •pregnant women
- •prisoners
- •terminal cancer pain
研究组 & 干预措施
Tapering doses of buprenorphine
Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
干预措施: buprenorphine/naloxone (Drug)
Steady doses of buprenrophine
Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
干预措施: buprenorphine/naloxone (Drug)
结局指标
主要结局
Relapse to Substance Abuse
时间窗: Six months
Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.
次要结局
- Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.(Baseline and six months)
- Treatment Retention.(Six months)