Smartphone-based Services for People Diagnosed With Opioid Use Disorder

Study Overview
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Brief Summary
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The purpose of the research is to check whether services and materials made available through a smartphone app are helpful to people who have been diagnosed with opioid disorder. Participants are asked to use an app to submit videos of themselves taking salivary drug tests to a secure online system. The app includes reminders, rewards, and activities, as well as access to live support. Study participation lasts one year and includes about 30 minutes each week submitting videos, an hour-long interview to get started, and hour-long interviews once every three months after that over the course of the year.

Detailed Description
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Purpose of the Study The purpose of the study is to evaluate the clinical and cost efficacy of the standard DynamiCare Health smartphone-smartcard platform as a means of promoting health and recovery for patients who are seeking treatment for problem opioid use. Experimental Design This is a prospective parallel randomized controlled trial with two study arms. The experimental group receives a smartphone-based program that includes incentives contingent upon drug abstinence and treatment attendance, access to a contingency management (CM) Guide who provides measurement-based peer coaching grounded in Community Reinforcement Approach, and self-paced Cognitive Behavioral Therapy (CBT) modules. The control group receives a smartphone-based sham program that includes incentives for submission of self-conducted salivary toxicology tests. Welcome Period After recruitment, participants will complete the Welcome Period. Participants will earn a total of $67 for completing the Welcome Period after they have downloaded the app and enrolled. After consenting, participants will enter the Welcome Period to learn the basics of how DynamiCare works before being randomized. During the Welcome Period, participants will have their equipment shipped to them, attend an orientation, and earn rewards for completing non-contingent practice saliva tests. The practice tests will be pre-scheduled. Members will advance to study randomization once they have: Completed an enrollment call and provided informed consent ($10) Received their equipment in the mail (saliva test kits and debit card) Completed Orientation: A session to learn how to use the DynamiCare app and understand how to perform saliva testing ($10 reward) Completed initial required surveys: Brief Addiction Monitor ($2), Demographics ($5), and Quality of Life ($5) Completed 2 saliva tests ($5 reward each, $10 total) Participants will also earn a $25 bonus for completing the Welcome Period and accepting Randomization. Randomization Upon successful completion of the Welcome Period the DynamiCare study coordinator will notify the Western Michigan University (WMU) study coordinator that a participant randomization is required. The WMU study coordinator will notify the WMU principal investigator or WMU graduate student investigator who is scheduled as the randomizer that they should conduct the randomization as soon as possible. As part of this request, the WMU study coordinator must supply the answers to the three stratification questions. The stratification variable questions are: Do any salivary drug tests taken during the Welcome Period show use of unprescribed drugs [Y/N]? Does the participant have Stimulant Use Disorder [Y/N]? and Is the participant already enrolled in Medication for Opioid Use Disorder (MOUD) [Y/N]? Once randomization is complete, the randomizer will inform the WMU study coordinator, who will inform DynamiCare Enrollment Team staff in turn. The DynamiCare Enrollment Team will then ensure assignment to the appropriate condition and conduct a notification call. Note that the purpose of the notification call is to explain to the participant what will happen during their Study Period. UNDER NO CIRCUMSTANCE SHOULD THE PARTICIPANT BE TOLD WHETHER THEY ARE IN THE EXPERIMENTAL OR CONTROL CONDITIONS. Once the participant is assigned to a condition in DynamiCare Analytics, they are considered fully enrolled and part of the intent-to-treat analysis. Assessment Overview Three types of assessments will be delivered throughout the study: Pre-Randomization, Self-Monitoring, and Major Assessments. A separate Excel file showing a diagram of all assessments and timepoints is available. This file also details the delivery mechanism and payment associated with each assessment. Pre-Randomization assessments will be delivered during the Welcome Period before participants are randomly assigned to Study Period groups. Self-Monitoring assessments will be delivered through the DynamiCare Health app at several timepoints throughout the study. Major Assessments will be delivered online and/or over the phone at five timepoints throughout the study. The exact schedule of all assessments is described in the subsections below. Most importantly, all participants will receive identical assessments independent of their group assignment. The only exception to this is the Invite a Supporter Survey. This assessment is delivered once to the experimental group only. Interviews Pre-Randomization Assessments. American Society of Addiction Medicine (ASAM) Co-Triage (eligibility) Demographic Questionnaire (Welcome Period) Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) Diagnostic Criteria Questionnaire (enrollment into Welcome Period) Brief Addiction Monitor (BAM) (intake and 4-week intervals) The World Health Organization (WHO) Quality of Life (intake and 12-week intervals) General Social Security Number Collection Form (enrollment into Welcome Period) Self-Monitoring Surveys. Brief Addiction Monitor (BAM) (4-week intervals including intake) Invite a Supporter Survey (intake for experimental group only) Major Assessments. Delay and Probability Discounting Task (intake/24-week intervals) Social Discounting Task (intake/24-week intervals) Opioid Discounting and Purchasing Task (intake/24-week intervals) Balloon Analog Risk Task (BART) (intake/24-week intervals) Beck Depression Inventory II (BDI-II) (intake/24-week intervals) Free Research Executive Function Evaluation (FREE) (intake/24-week intervals) Treatment Status Questionnaire (intake/12-week intervals) Self-reported Medications for Opioid Use Disorder (MOUD) adherence via 30-day timeline followback (intake/12-week intervals) Economic Form 90 (EF90) Healthcare Utilization Questionnaire (intake and 12-week intervals) Assessment of Blinding Success (12-week intervals excluding intake) Satisfaction Survey (12-week intervals excluding intake) Return to Work Survey (intake and 12-week intervals) Discharge Procedures Main study discharge will occur for all participants irrespective of group assignment upon completion of the final assessment conducted on the 48th week of the study period. Analytic Plan All analyses will be conducted on the Intent-to-Treat population in SAS 9.3 or higher and all hypothesis testing will be two-sided with a 5% significance level (SAS Institute, Inc; Cary, NC, USA). Generalized Estimating Equations (GEE) and Mixed models will be used to evaluate all primary and secondary outcomes. The goodness of fit of the models will be assessed using the Quasi-likelihood under the Independence model Criterion (QIC) to choose the best-fitting correlation structure. For each model, effect sizes will be estimated as odds ratios (for binary outcomes), rate ratios (for count outcomes), or differences in means (for continuous outcomes). These estimates will be assessed for precision using 95% confidence intervals. Both GEE and Mixed statistical techniques are particularly suited for analyses of longitudinal data and allow for correlations among observations within an individual subject, for the presence of missing data, for subjects measured at different timepoints, and for covariates that change over time. The response of individual subjects is first modeled, and then the estimates for each individual are combined in a group analysis. These analyses will permit an examination for effects of assignment to treatment condition, time effects associated with the course of treatment, and condition by time interactions.

Official Title
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Smartphone-based Services for People Diagnosed With Opioid Use Disorder

Conditions
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Opioid-Related Disorders, Drug Abuse

Intervention / Treatment
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* Behavioral: Contingency management
* Behavioral: Cognitive-Behavior Therapy Modules
* Behavioral: Peer Contingency Management (CM) Guide
* Behavioral: Drug testing
* Behavioral: Wellness modules
* Behavioral: Peer technical support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or older Lives in the United States Read and speak English fluently Owns a smartphone compatible with the DynamiCare app (e.g., Apple or Android) Diagnosed with opioid use disorder or attests to having problem opioid use Has used unprescribed opioids within the prior 30 days Has, or is willing to accept, an appointment to initiate medication assisted treatment or has initiated medication assisted treatment in the prior 45 days Must have an ASAM CO-Triage score between L1 and L3.1 Exclusion Criteria: Is currently enrolled in another study involving substance abuse treatment Has concurrent alcohol use disorder Is currently incarcerated Has current suicidal ideation or overt psychosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abstinence reinforcement<br>Participants earn incentives for submission of salivary drug toxicology video selfies that show test results consistent with the goals of treatment. Goals are abstinence-based (i.e., relate to which tested substances should be negative on the test given the medications that the particular participant has been prescribed). Incentives are also provided for attendance at treatment-related appointments and for completion of self-paced cognitive behavior therapy modules available via the smartphone app. | Behavioral: Contingency management<br>* Monetary incentives are delivered via reloadable debit card based on verified engagement in target behaviors, including drug abstinence, appointment attendance, and completion of self-paced cognitive behavior therapy modules.<br>* Other names: Cognitive-behavior therapy;Behavioral: Cognitive-Behavior Therapy Modules<br>* Self-paced cognitive-behavior therapy modules delivered via smartphone.<br>Behavioral: Peer Contingency Management (CM) Guide<br>* Peer supports delivered via telehealth. Support is informed by the community reinforcement approach and includes motivational interviewing<br>|
| Sham Comparator: Sample-contingent control<br>Identical to the experimental group except that incentives are available only for submission of selfie-videos that show test results, without regard to the results of the salivary drug toxicology test. Similarly, incentives are not provided for appointments or completion of wellness modules, and instead are based only on use of the app. | Behavioral: Drug testing<br>* Self-performed salivary drug testing with incentives contingent upon proper completion of test procedures as confirmed by video.<br>Behavioral: Wellness modules<br>* Basic health and wellness information delivered via self-paced learning modules.<br>Behavioral: Peer technical support<br>* Peer support for promoting engagement and addressing technical issues delivered via a mobile digital platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly drug use | Gas Chromatography Mass Spectrometry (GC/MS) assessment of saliva samples collected every four weeks. Dichotomous (Y/N), based on whether or not the test results are consistent with individualized requirements for drug test outcomes based on prescribed medications for that individual. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence from opioids | Abstinence from opioids as measured by GC/MS salivary drug toxicology testing (Y/N) collected every 4 weeks throughout the 48-week Study Period. | 48 weeks | 
| Lab-based abstinence from all unprescribed drugs | Abstinence from all unprescribed drugs as measured by GC/MS drug toxicology testing (Y/N) collected every 4 weeks throughout the first 16 weeks of the Study Period, during which contingency management (CM) incentives are included in the experimental group. | 16 weeks | 
| Self-conducted abstinence from all unprescribed drugs | Abstinence from all unprescribed drugs as measured by self-conducted salivary drug toxicology testing (Y/N), through the DynamiCare app, collected weekly throughout the first 16 weeks of the Study Period, during which contingency management (CM) incentives will be included in the experimental group. | 16 weeks | 
| Medications for Opioid Use Disorder (MOUD) participation | Self-reported MOUD participation status (Y/N) as assessed at quarterly assessments. | 48 weeks | 
| Days of Medications for Opioid Use Disorder (MOUD) adherence | Self-reported days of MOUD adherence as assessed at quarterly assessments. | 48 weeks | 
| Healthcare utilization | Healthcare utilization as assessed by the EF90 Healthcare Utilization Form. Assesses the following 90 days prior to completion: Overnight stay (Y/N) in a hospital Total nights spent in the hospital Total nights spent in the hospital due to drugs, alcohol, or mental health Overnight stay (Y/N) at treatment facility Total nights spent in treatment facility Emergency room visit (Y/N) Total emergency room visits Total emergency room visits related to alcohol, drug use, or mental health Outpatient substance use disorder treatment or counseling (Y/N) Total days of outpatient substance use disorder treatment or counseling Use of medications to treat opioid use disorder (Y/N) Total days of methadone use Total days of buprenorphine use Total injections of Vivitrol | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartphone, Telemedicine, Motivation, Incentives, Contingency Management