RAE (Realize, Analyze, Engage)

Substance Use Disorders Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227339
• Other study ID #: RAEPHASEII
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 22, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2023
• Source: ContinueYou, LLC
• Contact: Stephanie Carreiro, MD
• Phone: 5084211400
• Email: stephanie.carreiro[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders
• Treatment Adherence and Compliance

Intervention

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.

Locations

Country	Name	City	State
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
ContinueYou, LLC	University of Massachusetts, Worcester, University of Texas at Tyler

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants retained in treatment	Participants status as engaged in recovery treatment (index treatment program or other)	3 months
Secondary	Number of hospitalizations and emergency department visits per participant	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