Machine Learning Technology in Predicting Relapse and Implementing Peer Recovery Intervention Before Drug Use Occurs

March 20, 2025 updated by: James Mahoney, West Virginia University

The Utilization of Machine Learning Technologies in Predicting Relapse: Identifying Risk Factors and Implementing Intervention Before Drug Use Occurs

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia University Rockefeller Neuroscience Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Treatment as usual
Participants will receive standard of care treatment as usual and will receive no contact from a peer recover support specialist (PRSS intervention) when data anomalies are detected by machine learning algorithms.
Experimental: PRSS intervention
Participants receiving PRSS intervention will be contacted by the PRSS who will be blinded (not knowing whether an alert was caused by data anomaly or a random generation), and will contact the participant by phone and assess the need for assistance. PRSS will follow-up with the participant to assist participant if needed (once after the initial alert and then a second follow-up).
Other: PRSS (Peer Recovery Support Specialist)
Upon receiving an alert through a study dashboard, the PRSS (who is blinded in not knowing whether the alert was caused by data anomaly or a random generation), the PRSS will be able to access identifiable contact details and contact the participant by phone and provide the necessary support assistance (e.g., locations of AA/NA meetings, sleep and/or relaxation techniques, etc).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in heart rate
Time Frame: Daily up to 5 years
Beats per minute collected from participant connected wearable device
Daily up to 5 years
Changes in heart rate variability
Time Frame: Daily up to 5 years
Interbeat interval collected from participant connected wearable device
Daily up to 5 years
Changes in respiratory rate
Time Frame: Daily up to 5 years
Number of breaths per minute collected from participant connected wearable device
Daily up to 5 years
Changes in sleep onset
Time Frame: Daily up to 5 years
Time went to bed collected from participant connected wearable device
Daily up to 5 years
Changes in sleep efficiency
Time Frame: Daily up to 5 years
Percent of time in bed compared to total sleep time collected from participant connected wearable device
Daily up to 5 years
Changes in total sleep
Time Frame: Daily up to 5 years
Number of minutes slept at night collected from participant connected wearable device
Daily up to 5 years
Changes in sleep stages
Time Frame: Daily up to 5 years
Minutes of sleep spend in rapid eye movement, light, or deep sleep collected from participant collected wearable device
Daily up to 5 years
Changes in physical activity
Time Frame: Daily up to 5 years
Changes in activity levels as collected from participant connected wearable device
Daily up to 5 years
Erikson Flanker Task (response inhibition)
Time Frame: Once at the beginning of study (intake), and as needed for up to 5 years
A response inhibition test to assess the participant's ability to suppress a response that is inappropriate based on the task rules. Participants are to respond, left or right, to the direction of the middle arrow (target arrow) of five aligned items. The task consists of congruent stimulus (the direction of the target arrow and flanker arrows are the same), incongruent stimulus (the direction of the target arrow is opposite of the flanker arrows), and neutral stimulus (flanker items are different then the target arrow). The standard findings are that the incongruent stimulus has greater reaction times as compared to congruent and neutral stimulus. This task will measure changes in participant task responses from baseline as collected from the RNI Health app.
Once at the beginning of study (intake), and as needed for up to 5 years
N-Back Task
Time Frame: Once at the beginning of the study (intake), and as needed for up to 5 years
A measure of working memory where participants monitor a series of stimuli and respond whenever a stimulus is presented that is the same as the one presented in a predefined previous trial. Test are defined as items that are 1, 2, or 3 items back from the current stimulus, whereas 1-back is less difficult than the 3-back since less information is needed in working memory to correctly respond. This task will measure changes in participant memory task responses from baseline as collected from the RNI Health app.
Once at the beginning of the study (intake), and as needed for up to 5 years
Delayed Discounting Task
Time Frame: Once at the beginning of the study (intake), and as needed for up to 5 years
This measure assesses cognitive functions which are often impaired in substance users including: decision making, impulsivity, and inhibitory control. The task presents participants with hypothetical choices between a smaller amount of money available immediately, or a larger amount at a delayed time point (e.g., "Would you rather have $1000 in 30 days or $200 now?"; Richards et al., 1999). An adjusting procedure is used to derive indifference values, between the delayed and immediate amounts. An indifference value reflects the smallest amount of money an individual chooses to receive immediately instead of the delayed amount at each time-point. This task will measure changes in participant delayed discounting responses from baseline as collected from the RNI Health app.
Once at the beginning of the study (intake), and as needed for up to 5 years
Balloon Analogue Risk Task
Time Frame: Once at the beginning of the study (intake), and as needed for up to 5 years
Computerized measure of risk-taking behavior modeling real world risk behavior through the concept of reward versus loss. Participant is presented with a balloon and offered the chance to earn hypothetical money by pumping the balloon button clicks. Each click causes the balloon to incrementally inflate and money to be added to a counter up to some threshold, then the balloon over inflates and explodes. Each pump confers greater risk, but also greater potential reward. If the participant chooses to cash-out prior to the balloon exploding then they collect the money earned, but if the balloon explodes, trial earnings are lost. This task will measure changes in participant responses from baseline as collected from the RNI Health app.
Once at the beginning of the study (intake), and as needed for up to 5 years
Ecological Momentary Assessment
Time Frame: Daily for up to 5 years
The EMA questionnaire will assess substance use and cravings, emotional symptoms, presence of pain, and quality of sleep. Changes in participant responses will be assessed daily as collected from the RNI Health app.
Daily for up to 5 years
The Emotion Regulation Questionnaire
Time Frame: Monthly for up to 5 years
The Emotion Regulation Questionnaire (ERQ) is a 10-item self-report scale designed to assess habitual use of two commonly used strategies to alter emotion: cognitive reappraisal and expressive suppression. Participants respond to each item using a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Changes in participant responses will be assessed monthly as collected from the RNI Health app.
Monthly for up to 5 years
Patient Health Questionnaire
Time Frame: Monthly for up to 5 years
The PHQ-9 is the nine-item depression scale of the patient health questionnaire. It is one of the most validated tools in mental health and can be a powerful tool to assist clinicians with diagnosing depression and monitoring treatment response. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The primary outcome will be the total score of all responses. Changes in participant responses will be assessed monthly as collected from the RNI Health app.
Monthly for up to 5 years
General Anxiety Disorder
Time Frame: Monthly for up to 5 years
The GAD-7 is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of their symptoms over the past two weeks. Changes in participant responses will be assessed monthly as collected from the RNI Health app.
Monthly for up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West Virginia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James J Mahoney, Ph.D., West Virginia University Rockefeller Neuroscience Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2303735843

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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