RAE (Realize, Analyze, Engage)

Phase 2

Completed

• Conditions: Treatment Adherence and Compliance; Substance Use Disorders
• Interventions: Device: RAE

• Registration Number: NCT05227339
• Lead Sponsor: ContinueYou, LLC

Brief 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.

Study Timeline

• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-07
• Study Start: 2022-02-22
• Primary Completion: 2024-02-01
• Study Completion: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnancy
• Prisoner Status
• Significant limitation of range of motion of non-dominant arm (amputation or fracture)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional (RAE + Usual Care)	RAE	Subjects will receive usual care through an outpatient substance use disorder treatment facility, will be provided with a wearable sensor and the RAE mobile application. Participants will be instructed to use the RAE app for a minimum of 30 days.

Primary Outcome Measures

Name	Time	Method
Number of participants with return to drug use	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)

Secondary Outcome Measures

Name	Time	Method
Number of participants retained in treatment	3 months	Participants status as engaged in recovery treatment (index treatment program or other)
Number of hospitalizations and emergency department visits per participant	3 months	Includes absolute number of Emergency Department visits (SUD and non-SUD related), number of unplanned hospital admissions (SUD and non-SUD related), number of days hospitalized (SUD and non-SUD related admissions) and overdose related visits

Trial Locations

Locations (1)

University of Massachusetts Chan Medical School; 🇺🇸 Worcester, Massachusetts, United States