Viewing Study NCT06134882



Ignite Creation Date: 2024-05-06 @ 7:47 PM
Last Modification Date: 2024-10-26 @ 3:13 PM
Study NCT ID: NCT06134882
Status: RECRUITING
Last Update Posted: 2024-06-21
First Post: 2023-11-06

Brief Title: OUD Smartphone Services
Sponsor: Western Michigan University
Organization: Western Michigan University

Study Overview

Official Title: Smartphone-based Services for People Diagnosed With Opioid Use Disorder
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 YN
2 Has the person been diagnosed with Stimulant Use Disorder or have problem stimulant use YN and
3 Is the participant already enrolled in Medication for Opioid Use Disorder MOUD YN 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 andor 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 intake12-week intervals
3 Delay and Probability Discounting Task intake24-week intervals
4 Social Discounting Task intake24-week intervals
5 Opioid Discounting and Purchasing Task intake24-week intervals
6 Balloon Analog Risk Task BART intake24-week intervals
7 Patient Health Questionnaire-9 PHQ-9
8 Timeline Followback TLFB for MOUD adherence intake12-week intervals intervals
9 Treatment Status Questionnaire intake12-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 patients 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 eg eventually just every two weeks With relapses however the app tests more frequently eg up to two tests every week The incentive amount is inversely related to the frequency of the tests with a maximum of 30week 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 eg 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 GCMass 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 93 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R44DA055396 NIH None httpsreporternihgovquickSearchR44DA055396