Clinical trial NCT05227339: RAE (Realize, Analyze, Engage)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Substance Use Disorders
Treatment Adherence and Compliance
Keywords: mhealth
stress
craving
wearables
technology
digital diagnostics
digital health
Lead sponsor: ContinueYou, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Massachusetts, Worcester
name: University of Texas at Tyler
First posted: 2022-02-07
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with return to drug use
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants retained in treatment
timeFrame: 3 months
measure: Number of hospitalizations and emergency department visits per participant
timeFrame: 3 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
Study officials:
affiliation: ContinueYou, LLC
name: Megan Reinhardt
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.