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

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West Virginia University

Status

Active, not recruiting

Conditions

Substance Abuse Disorder

Treatments

Other: PRSS (Peer Recovery Support Specialist)

Study type

Interventional

Funder types

Other

Identifiers

NCT05976672
2303735843

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 2 patient groups

Treatment as usual
No Intervention group
Description:
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 group
Description:
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).
Treatment:
Other: PRSS (Peer Recovery Support Specialist)

Trial contacts and locations

1

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Central trial contact

Jennifer L Marton, BS; James J Mahoney, Ph.D.

Data sourced from clinicaltrials.gov

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