Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 35
- 主要终点
- Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24
研究概览
简要总结
The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine extended-release injection (RBP-6000). The study population will consist of participants from studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003).
The RECOVER study will characterize OUD subjects' recovery process as they transition from the controlled clinical trial environment to the real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects who received at least one injection in RBP-6000 or placebo in the Phase III clinical program which includes study protocols NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) and either withdrew from or completed these studies.
- •Ability to comply with study protocol requirements for data collection and provide informed consent.
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24
时间窗: Month 24
Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).
Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 28 Days At Months 3, 6, 9, 12, 15, 18, 21, 24
时间窗: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).
Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days At Months 3, 6, 9, 12, 15, 18, 21, 24
时间窗: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).
Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by UDS At Months 3, 6, 9, 12, 15, 18, 21, 24
时间窗: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.
Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24
时间窗: Month 24
Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.
次要结局
未报告次要终点