RAE (Realize, Analyze, Engage)- A Digital Biomarker Based Detection and Intervention System for Stress and Craving During Recovery From Substance Use Disorder: Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Number of participants with return to drug use
研究概览
简要总结
The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder
详细描述
RAE integrates digital detection of high-risk stress and craving periods by utilizing a mobile phone application and integrated wearable sensor. These detections are paired with interventions (mindfulness based de-escalation tools), support, and monitoring (to identify trends and plan for future). The present study will deploy the technology in a multi-site randomized controlled trial to test the efficacy of the RAE system in on clinical and psychosocial outcomes. Subjects will be randomized to use the RAE system (mobile app and wearable sensor) plus usual care vs usual care plus a fitness tracker only to measure differences retention in treatment, return to substance use, and overall psychosocial functioning. The ultimate goal is to develop a cost-effective, paradigm changing recovery tool that will improve substance use disorder treatment, and prevent related complications and deaths.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Enrolled in an outpatient SUD treatment program
- •Enrolled in treatment for < 90 days
- •Fluent in English
- •Have access to a smartphone with iOS or Android Capabilities
- •Capable of providing informed consent
排除标准
- •Pregnancy
- •Prisoner Status
- •Significant limitation of range of motion of non-dominant arm (amputation or fracture)
结局指标
主要结局
Number of participants with return to drug use
时间窗: 3 months
Relapse to use of substance use defined as 1) self-reported use, 2) positive urine drug screen (from treatment program) or 3) provider report of confirmed relapse (Only applies to substances for which subject is receiving treatment)
次要结局
- Number of participants retained in treatment(3 months)
- Number of hospitalizations and emergency department visits per participant(3 months)