NCT05227339

RAE (Realize, Analyze, Engage)

RAE (Realize, Analyze, Engage)- A Digital Biomarker Based Detection and Intervention System for Stress and Craving During Recovery From Substance Use Disorder: Phase II

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: ContinueYou, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Substance Use Disorders
• Treatment Adherence and Compliance

Interventions

Type	Name	Description
DEVICE	RAE	Subjects in the interventional group will have access to the RAE Health mobile app which receives continuous physiologic data from a wearable device. Algorithms embedded in the RAE app detect stress and craving events, and trigger mobile phone notifications when detected. Notifications are paired to real-time mindfulness based interventions.

Timeline

• Start date: 2022-02-22
• Primary completion: 2024-02-01
• Completion: 2024-04-01
• First posted: 2022-02-07
• Last updated: 2024-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study