Substance Abuse DisorderNCT05976672
Machine Learning Technology in Predicting Relapse and Implementing Peer Recovery Intervention Before Drug Use Occurs
A study testing PRSS (Peer Recovery Support Specialist) in people with Substance Abuse Disorder, run by West Virginia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse Disorder
- What is being tested?
- PRSS (Peer Recovery Support Specialist)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2023to 26 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to give informed consent
- Inability to download the RNI Health app and wearable device apps onto their smart device
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26505
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Abuse Disorder
- Being tested
- PRSS (Peer Recovery Support Specialist)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRSS (Peer Recovery Support Specialist)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | 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. |
| PRSS intervention | Experimental | 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). Receives: Other: PRSS (Peer Recovery Support Specialist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rate
Beats per minute collected from participant connected wearable device
Measured: Daily up to 5 years
Changes in heart rate variability
Interbeat interval collected from participant connected wearable device
Measured: Daily up to 5 years
Changes in respiratory rate
Number of breaths per minute collected from participant connected wearable device
Measured: Daily up to 5 years
Changes in sleep onset
Time went to bed collected from participant connected wearable device
Measured: Daily up to 5 years
Changes in sleep efficiency
Percent of time in bed compared to total sleep time collected from participant connected wearable device
Measured: Daily up to 5 years
Changes in total sleep
Number of minutes slept at night collected from participant connected wearable device
Measured: Daily up to 5 years
Changes in sleep stages
Minutes of sleep spend in rapid eye movement, light, or deep sleep collected from participant collected wearable device
Measured: Daily up to 5 years
Changes in physical activity
Changes in activity levels as collected from participant connected wearable device
Measured: Daily up to 5 years
Erikson Flanker Task (response inhibition)
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.
Measured: Once at the beginning of study (intake), and as needed for up to 5 years
N-Back Task
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.
Measured: Once at the beginning of the study (intake), and as needed for up to 5 years
Delayed Discounting Task
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.
Measured: Once at the beginning of the study (intake), and as needed for up to 5 years
Balloon Analogue Risk Task
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.
Measured: Once at the beginning of the study (intake), and as needed for up to 5 years
Ecological Momentary Assessment
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.
Measured: Daily for up to 5 years
The Emotion Regulation Questionnaire
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.
Measured: Monthly for up to 5 years
Patient Health Questionnaire
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.
Measured: Monthly for up to 5 years
General Anxiety Disorder
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.
Measured: Monthly for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start27 Apr 2023
- Primary completion26 Apr 2028 (estimated)
- Study completion26 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Mahoney, West Virginia University
- Investigators
- James J Mahoney, Ph.D., Principal investigator, West Virginia University Rockefeller Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976672
- Sponsor's protocol ID
- 2303735843
- Status last verified
- Mar 2025
- First submitted
- 17 Jul 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of Machine Learning Technologies in Predicting Relapse: Identifying Risk Factors and Implementing Intervention Before Drug Use Occurs
- ClinicalTrials.gov ID
- NCT05976672
- Acronym / sponsor ID
- 2303735843
- Conditions
- Substance Abuse Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 26 Apr 2028 (estimated)
- Study completion
- 26 Apr 2028 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –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. |
| PRSS intervention | Experimental | Other: PRSS (Peer Recovery Support Specialist)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to give informed consent
- Inability to download the RNI Health app and wearable device apps onto their smart device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | PRSS intervention |
Primary outcome
Changes in heart rate
Time frame: Daily up to 5 years
Beats per minute collected from participant connected wearable device
Changes in heart rate variability
Time frame: Daily up to 5 years
Interbeat interval collected from participant connected wearable device
Changes in respiratory rate
Time frame: Daily up to 5 years
Number of breaths per minute collected from participant connected wearable device
Changes in sleep onset
Time frame: Daily up to 5 years
Time went to bed collected from participant connected wearable device
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
Changes in total sleep
Time frame: Daily up to 5 years
Number of minutes slept at night collected from participant connected wearable device
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
Changes in physical activity
Time frame: Daily up to 5 years
Changes in activity levels as collected from participant connected wearable device
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J Mahoney, Ph.D. principal investigator
West Virginia University Rockefeller Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRSS (Peer Recovery Support Specialist) in people with Substance Abuse Disorder, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart rate (time frame: Daily up to 5 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.