Clinical trial NCT06134882: OUD Smartphone Services
Official title: Smartphone-based Services for People Diagnosed With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid-Related Disorders
Drug Abuse
Keywords: Smartphone
Telemedicine
Motivation
Incentives
Contingency Management
Lead sponsor: Western Michigan University
Sponsor class: OTHER
Collaborators: name: DynamiCare Health Inc.
name: RTI International
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-11-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 use disorder (OUD). 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: Purpose of the Study

The purpose of the study is to evaluate the safety, clinical effectiveness, and cost effectiveness 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 to a study condition. 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:

1. Do any salivary drug tests taken during the Welcome Period show use of unprescribed drugs \[Y/N\]?
2. Has the person been diagnosed with Stimulant Use Disorder or have problem stimulant use \[Y/N\]? and
3. 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 1) either by phone during enrollment calls into the Welcome Period or 2) through the DynamiCare Health app during the Welcome Period before participants are randomly assigned to Study Period groups.
* Self-Monitoring assessments will be delivered through the DynamiCare Health app every 4 weeks 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.

1. American Society of Addiction Medicine (ASAM) Co-Triage (eligibility)
2. Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) Diagnostic Criteria Questionnaire (eligibility)
3. General Social Security Number Collection Form (enrollment call into Welcome Period)
4. Demographic Questionnaire (Welcome Period)
5. Brief Addiction Monitor (BAM) (Welcome Period)
6. The World Health Organization (WHO) Quality of Life (Welcome Period)

Self-Monitoring Surveys.

1. Brief Addiction Monitor (BAM) (intake and 4-week intervals)

Major Assessments.

1. Invite a Supporter Survey (intake for experimental group only)
2. WHO Quality of Life (intake/12-week intervals)
3. Delay and Probability Discounting Task (intake/24-week intervals)
4. Social Discounting Task (intake/24-week intervals)
5. Opioid Discounting and Purchasing Task (intake/24-week intervals)
6. Balloon Analog Risk Task (BART) (intake/24-week intervals)
7. Patient Health Questionnaire-9 (PHQ-9)
8. Timeline Followback (TLFB) for MOUD adherence (intake/12-week intervals intervals)
9. Treatment Status Questionnaire (intake/12-week intervals)
10. Economic Form 90 (EF90) Healthcare Utilization Questionnaire (intake and 12-week intervals)
11. Assessment of Blinding Success (12-week intervals excluding intake)
12. Satisfaction Survey (12-week intervals excluding intake)
13. Return to Work Self-Efficacy Survey (intake and 12-week intervals)
14. Flexpa data collection (intake, 24-week intervals)

Salivary Toxicology

Standard Salivary Toxicology. Salivary toxicology testing will be initially conducted twice per week, scheduled at random within the patient's designated time window (usually set between 8 AM-10 PM). For experimental group patients, the app uses a progressive reinforcement schedule for drug testing and rewards: with consecutive abstinences it tests the patient less frequently (e.g., eventually just every two weeks). With relapses, however, the app tests more frequently (e.g., up to two tests every week). The incentive amount is inversely related to the frequency of the tests, with a maximum of $30/week for all incentivized behavioral tasks (including CBT module completion and appointment attendance).

For the experimental group, substance tests will be reinforced contingent on abstinence from any non-prescribed drugs. A positive result for any prescribed drugs is not a requirement for reinforcement. For the control group, substance tests will be reinforced on a fixed schedule, contingent only on submission. All incentives will be available to participants through the 48-week Study Period.

The drug test panel that will be used with both study groups will include tests for a variety of opioids (e.g., including tests for buprenorphine, methadone, fentanyl), cocaine, methamphetamine, and benzodiazepines.

Primary Outcome Salivary Toxicology. In addition to the salivary drug toxicology tests that are performed according to the random schedule, there will also be a set of salivary toxicology tests that will be used as the primary outcome of the study. These tests will be independently analyzed by a laboratory at a frequency of once per month, with the first of these tests scheduled at the start of the Study Period. These samples will be sent to Quest Diagnostics for GC/Mass spec testing. A video selfie, sent to the WMU study team via OneDrive, will be required to ensure that the sample is properly provided by the correct participant. A payment of $20 will be made each month by the WMU study coordinator for the submission of this sample. Payment will be delivered after Quest Diagnostics provides the results of the toxicology test as confirmed by the WMU study coordinator.

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. Because the FDA considers people aged 18-21 to be adolescents, and people 22 or over to be adults, we will perform a sub-group analysis for adolescents.

Eligibility criteria: 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

Primary outcomes:
measure: Independent lab-based salivary drug toxicology for abstinence from all unprescribed drugs (initial 16 weeks)
timeFrame: Initial 16 weeks
Secondary outcomes:
measure: Lab-based salivary drug toxicology for abstinence from all unprescribed drugs (weeks 17-48)
timeFrame: Weeks 17-48
measure: Medications for Opioid Use Disorder (MOUD) participation
timeFrame: 48 weeks
measure: Days of Medications for Opioid Use Disorder (MOUD) adherence
timeFrame: 48 weeks
measure: Healthcare utilization
timeFrame: 48 weeks
measure: Frequency of Adverse Events
timeFrame: 48 weeks
Other outcomes:
measure: Total Incentive earnings
timeFrame: 48 weeks
measure: Self-reported drug use
timeFrame: 48 weeks
measure: Quality of Life assessment
timeFrame: 48 weeks
measure: Self-conducted abstinence from all unprescribed drugs
timeFrame: 16 weeks
Locations:
city: Kalamazoo
country: United States
facility: Western Michigan University
state: Michigan
Study officials:
References: