RAE (Realize, Analyze, Engage)

July 24, 2024 updated by: ContinueYou, LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Chan Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional (RAE + Usual Care)
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.
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.
Other Names:
  • RAE Mobile App
No Intervention: Control (Usual care)
Subjects will receive usual care through an outpatient substance use disorder treatment facility and will be provided with a wearable sensor (fitness tracker). They will not be given access to the RAE mobile app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants retained in treatment
Time Frame: 3 months
Participants status as engaged in recovery treatment (index treatment program or other)
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ContinueYou, LLC

Collaborators

University of Massachusetts, Worcester
University of Texas at Tyler

Investigators

  • Principal Investigator: Megan Reinhardt, ContinueYou, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAEPHASEII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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