Employment-Based Depot Naltrexone Clinical Trial II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Time to the First Missed Dose
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 to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults. Vivitrol, an extended-release depot formulation of naltrexone approved by the FDA for the treatment of alcohol dependence, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) 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. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections 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
Work Plus Naltrexone Prescription
Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers.
Work Plus Naltrexone Contingency
Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement.
干预措施: Work Plus Naltrexone Contingency (Combination Product)
结局指标
主要结局
Time to the First Missed Dose
时间窗: 24 weeks
The time to the first missed dose of depot naltrexone
Naltrexone Injections Received
时间窗: 24 weeks
The percentage of depot naltrexone doses that participants received
次要结局
- HIV Risk Behaviors(24 weeks)
- Percentage of 30-day Urine Samples Negative for Opiates(Collected every 30 days for 150 days)
- Percentage of M-W-F Samples Negative for Cocaine(Collected every Monday, Wednesday and Friday for 24 weeks)
- Average Percentage of 30-day Urine Samples Negative for Cocaine(Collected every 30 days for 150 days)
- Percentage of M,W,F Urine Samples Negative for Opiates(Collected every Monday, Wednesday and Friday for 24 weeks)