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OpenTrials
Completed

NCT Number: NCT05227339

RAE (Realize, Analyze, Engage)

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

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Key information

Conditions

Substance Use Disorders Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RAE

Device

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.

Other names: RAE Mobile App

Primary outcomes

  1. Number of participants with return to drug use

    Time frame: 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 outcomes

  1. Number of participants retained in treatment

    Time frame: 3 months

    Participants status as engaged in recovery treatment (index treatment program or other)

  2. Number of hospitalizations and emergency department visits per participant

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ContinueYou, LLC

Industry

Collaborators

  • University of Massachusetts, Worcester
  • University of Texas at Tyler

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2022
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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