RAE (Realize, Analyze, Engage)

NCT05227339 | Completed Phase 2 DMC FDA Device

• 1 other identifier: RAEPHASEII
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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

Conditions

Substance Use Disorders; Treatment Adherence and Compliance

Keywords

mhealth; stress; craving; wearables; technology; digital diagnostics; digital health

Outcome Measures

Primary Outcomes (1)

• Number of participants with return to drug use

  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 Outcomes (2)

• Number of participants retained in treatment

  3 months

• Number of hospitalizations and emergency department visits per participant

  3 months

Study Arms (2)

Interventional (RAE + Usual Care)

EXPERIMENTAL

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

Control (Usual care)

NO INTERVENTION

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.

Interventions

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.

Also known as: RAE Mobile App

Interventional (RAE + Usual Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ContinueYou, LLC: lead
• University of Massachusetts, Worcester: collaborator
• University of Texas at Tyler: collaborator

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

• Carreiro S, Taylor M, Shrestha S, Reinhardt M, Gilbertson N, Indic P. Realize, Analyze, Engage (RAE): A Digital Tool to Support Recovery from Substance Use Disorder. J Psychiatr Brain Sci. 2021;6:e210002. doi: 10.20900/jpbs.20210002. Epub 2021 Feb 24.

  PMID: 33748430 BACKGROUND

• Carreiro S, Chintha KK, Shrestha S, Chapman B, Smelson D, Indic P. Wearable sensor-based detection of stress and craving in patients during treatment for substance use disorder: A mixed methods pilot study. Drug Alcohol Depend. 2020 Apr 1;209:107929. doi: 10.1016/j.drugalcdep.2020.107929. Epub 2020 Mar 3.

  PMID: 32193048 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Megan Reinhardt

  ContinueYou, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 7, 2022
• Study Start: February 22, 2022
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)