NCT03838510已完成不适用
Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- Number of Overdose Events
研究概览
简要总结
REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients with opioid use disorder. It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of REBOOT vs attention-control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Age 18-65 years
- •Characteristics of opioid use history
- •Previously received take-home naloxone
- •No life-threatening illness likely to progress clinically during trial
- •Able/willing to provide informed consent and locator information, communicate in English, and adhere to visit schedule
排除标准
- •Suicidal ideation
- •Participating in another interventional study that could possibly impact the study's outcomes of interest
- •Planning to leave San Francisco/Boston metro area during study
- •Previously exposed to REBOOT counseling intervention
- •Any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures
研究组 & 干预措施
Brief Counseling Intervention
Experimental
干预措施: REBOOT (Behavioral)
Control Group
No Intervention
结局指标
主要结局
Number of Overdose Events
时间窗: 16 Months
Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
次要结局
未报告次要终点
研究者
Phillip Coffin, MD, MIA
Director, Substance Use Research Unit
San Francisco Department of Public Health
研究点 (2)
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