Employment-Based Depot Naltrexone Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Percentage of Depot Naltrexone Doses Received
研究概览
简要总结
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
详细描述
A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Employment-based reinforcement
Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
干预措施: employment-based reinforcement (Combination Product)
No Intervention
Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
结局指标
主要结局
Percentage of Depot Naltrexone Doses Received
时间窗: 18 Weeks
The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.
次要结局
- The Time to the First Missed Dose of Depot Naltrexone(18 weeks)
- Percentage of 30-day Assessments Urine Samples Negative for Cocaine(4 months)
- Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine(18 weeks)
- Percentage of 30-day Assessments Urine Samples Negative for Opiates(4 months)
- Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates(18 weeks)
- HIV Risk Behaviors(4 months)