RAE (Realize, Analyze, Engage)

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Status and phase: Completed; Phase 3; Phase 2

Conditions: Substance Use Disorders; Treatment Adherence and Compliance

Treatments: Device: RAE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05227339

RAEPHASEII

Details and patient eligibility

About

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

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 2 patient groups

Interventional (RAE + Usual Care)

Experimental group

Description:

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.

Treatment:

Device: RAE

Control (Usual care)

No Intervention group

Description:

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.