Clinical trial NCT05976672: Machine Learning Technology in Predicting Relapse and Implementing Peer Recovery Intervention Before Drug Use Occurs
Official title: The Utilization of Machine Learning Technologies in Predicting Relapse: Identifying Risk Factors and Implementing Intervention Before Drug Use Occurs
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Abuse Disorder
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be initially monitored for three months before being randomized in a 1:1 ratio to receive either their standard of care treatment as usual, or the PRSS intervention (Peer Recovery Support Specialist)
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to study the relationship between substance cravings, cognitive performance, behaviors, and physiological markers in individuals with substance use disorder, as well as the effects of peer recovery intervention in response to abnormal biomarker data detected by wearable technology (e.g., Oura ring, smart watch) and participant responses to questionnaires and cognitive tasks completed on the RNI Health application.

Detailed description: The purpose of this study is to examine the relationship between cravings, cognitive performance, behaviors, and physiological markers in individuals with substance use disorder as well as the effects of peer-recovery intervention in response to biomarker data anomalies via wearable technology (e.g., Oura ring), and participant responses to questionnaires and cognitive tasks via the RNI Health application. All participants will initially be monitored for 3 months before being randomized to one of the following arms: 1) Treatment as usual; 2) PRSS (Peer Recovery Support) intervention. Participants will be randomized in a 1:1 ratio to receive either standard-of-care treatment (treatment as usual), or PRSS intervention. Participants will be asked to continuously wear a wearable device that measures heart rate, sleep, and physical activity for up to 5 years. Participants will also be asked to complete questionnaires about health, thinking and emotions, past experiences, and social background, as well as completing cognitive and physiological tasks when indicated. Questionnaires will be completed via the WVU RNI Health app on a smart device. Participant data will be analyzed through machine learning algorithms and standard statistical analyses. The researchers plan to identify abnormalities in participant data such as physiological biomarkers, cognitive performance, behaviors, and level of cravings associated with the increased risk for relapse and related mood conditions, in which participants may be contacted by a Peer Recovery Support Specialist (PRSS) to assess any participant needs, such as linkage or referral to resources (treatment options, housing resources, etc.) based on their standard of care. The objectives to the research are to develop machine-learning algorithms to predict risk for drug use recurrence, to develop a predictive model that may help determine prognosis and improve treatment planning based on physiological, cognitive, and behavioral response patterns, evaluate the efficacy of Peer Recovery Support Specialist interventions in preventing drug use recurrence, and use the data to better understand how wearable technology can help improve treatment plans.

Eligibility criteria: Inclusion Criteria:

* Male or Female 18 years of age or older
* Current or previous enrollment as a patient in a WVU Medicine Clinic for treatment of substance use disorder (e.g., residential, detoxification, inpatient, or outpatient), or a resident of a sober living facility.

Exclusion Criteria:

* Inability to give informed consent
* Inability to download the RNI Health app and wearable device apps onto their smart device

Primary outcomes:
measure: Changes in heart rate
timeFrame: Daily up to 5 years
measure: Changes in heart rate variability
timeFrame: Daily up to 5 years
measure: Changes in respiratory rate
timeFrame: Daily up to 5 years
measure: Changes in sleep onset
timeFrame: Daily up to 5 years
measure: Changes in sleep efficiency
timeFrame: Daily up to 5 years
measure: Changes in total sleep
timeFrame: Daily up to 5 years
measure: Changes in sleep stages
timeFrame: Daily up to 5 years
measure: Changes in physical activity
timeFrame: Daily up to 5 years
measure: Erikson Flanker Task (response inhibition)
timeFrame: Once at the beginning of study (intake), and as needed for up to 5 years
measure: N-Back Task
timeFrame: Once at the beginning of the study (intake), and as needed for up to 5 years
measure: Delayed Discounting Task
timeFrame: Once at the beginning of the study (intake), and as needed for up to 5 years
measure: Balloon Analogue Risk Task
timeFrame: Once at the beginning of the study (intake), and as needed for up to 5 years
measure: Ecological Momentary Assessment
timeFrame: Daily for up to 5 years
measure: The Emotion Regulation Questionnaire
timeFrame: Monthly for up to 5 years
measure: Patient Health Questionnaire
timeFrame: Monthly for up to 5 years
measure: General Anxiety Disorder
timeFrame: Monthly for up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Rockefeller Neuroscience Institute
state: West Virginia
Study officials:
affiliation: West Virginia University Rockefeller Neuroscience Institute
name: James J Mahoney, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: