Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain severity
研究概览
简要总结
The purpose of this study is to develop and pilot test clinical guidelines for the use of buprenorphine for the treatment chronic pain among patients with substance abuse histories. Buprenorphine, an opioid medication, holds promise as a treatment of chronic pain because, compared to most other opioid analgesics, it has a high safety profile, a low level of physical dependence, and mild withdrawal symptoms on cessation. Moreover there are promising reports from Europe of its use as a skin patch to treat chronic pain as well as clinical reports in the U.S. that it may be effective when used sublingually (placed under the tongue). This study will test the sublingual formulation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing treatment for moderate-severe chronic pain for at least six months at either an ambulatory practice of the Department of Pain and Palliative Medicine Beth Israel Medical Center in New York City or the the Peter Kruger Clinic at the same institution.
- •On opioid therapy (any dose) and observed to have had at least four of the aberrant drug-related behaviors described in (Passik et al. Clin J Pain; 22(2):173-81 2006) during the past six months, or
- •Considered a candidate for long-term therapy by the pain specialist and a history of a substance use disorder, as determined by DSM-IV criteria, but no longer meeting criteria for at least one year.
排除标准
- •Meets DSM-IV criteria for current opioid dependence or other substance use disorder including alcohol abuse.
- •Currently being treated for opioid dependence with methadone.
- •Currently maintained on naltrexone (e.g., for alcohol dependence).
- •Taking benzodiazepines on a daily basis.
- •A history of moderate-severe cardiopulmonary disease or symptoms or signs consistent with moderate-severe cardiopulmonary disease.
- •Elevated liver function test (LFT) results (> 2.5 above normal).
研究组 & 干预措施
A
干预措施: buprenorphine (Drug)
结局指标
主要结局
Pain severity
时间窗: 1, 2, 3, 4, 5 & 6 months
次要结局
- Pain behaviors, psychiatric distress, drug use, side effects(Months 1 through 6)