Linking Hospitalized Injection Drug Users to Buprenorphine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- opioid use
研究概览
简要总结
This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.
详细描述
In this randomized controlled trial, medically hospitalized opioid dependent patients will be assigned to a "treatment as usual" group, where they will receive a detox regiment of Suboxone during their hospital stay, or a "linkage" group, where they receive a maintenance course of Suboxone during their hospital stay, and appointment post-discharge with an outpatient Suboxone clinic/provider and a Suboxone prescription to use between discharge and this appointment. Study interviews are completed at baseline, and 1, 3- and 6-months post-baseline. Primary outcomes are opioid use and HIV risk behavior.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Current opioid injector, at least weekly in the past month
- •Current opioid dependence, SCID confirmed
- •Currently receiving an inpatient buprenorphine detoxification protocol.
排除标准
- •Patients unable to be interviewed due to acute illness or cognitive impairment
- •In police custody, expecting incarceration
- •Persons who cannot provide two contact persons (including shelters, parole officers, etc.) to verify location
- •Not able to complete assessments in English
- •Enrolled in a methadone maintenance program
- •Plans to leave the area within the next 6 months.
结局指标
主要结局
opioid use
时间窗: baseline, 1-month, 3-months, 6-months
HIV risk behavior
时间窗: baseline, 1-month, 3-months, 6-months
次要结局
- reduction in injection-related medical conditions(baseline, 1-month, 3-months, 6-months)
- reduction in emergency department and hospital utilization(baseline, 1-month, 3-months, 6-months)
研究者
Michael Stein, MD
Principal Investigator
Butler Hospital