OUD Smartphone Services

NCT06134882 | Active Not Recruiting

• 2 other identifiers: IRB-2023-30R44DA055396
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders; Drug Abuse

Keywords

Smartphone; Telemedicine; Motivation; Incentives; Contingency Management

Outcome Measures

Primary Outcomes (1)

• Independent lab-based salivary drug toxicology for abstinence from all unprescribed drugs (initial 16 weeks)

  Abstinence from all unprescribed drugs as measured by independent, lab-based salivary toxicology testing (Y/N) collected every 4 weeks throughout the initial 16-week Study Period.

  Initial 16 weeks

Secondary Outcomes (5)

• Lab-based salivary drug toxicology for abstinence from all unprescribed drugs (weeks 17-48)

  Weeks 17-48

• Medications for Opioid Use Disorder (MOUD) participation

  48 weeks

• Days of Medications for Opioid Use Disorder (MOUD) adherence

  48 weeks

• Healthcare utilization

  48 weeks

• Frequency of Adverse Events

  48 weeks

Other Outcomes (4)

• Total Incentive earnings

  48 weeks

• Self-reported drug use

  48 weeks

• Quality of Life assessment

  48 weeks

Study Arms (2)

Abstinence reinforcement

EXPERIMENTAL

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; Behavioral: Cognitive-Behavior Therapy Modules; Behavioral: Peer Contingency Management (CM) Guide

Sample-contingent control

SHAM COMPARATOR

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.

Behavioral: Drug testing; Behavioral: Wellness modules; Behavioral: Peer technical support

Interventions

Contingency management BEHAVIORAL

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.

Also known as: Abstinence reinforcement

Abstinence reinforcement

Cognitive-Behavior Therapy Modules BEHAVIORAL

Self-paced cognitive-behavior therapy modules delivered via smartphone.

Abstinence reinforcement

Peer Contingency Management (CM) Guide BEHAVIORAL

Peer supports delivered via telehealth. Support is informed by the community reinforcement approach and includes motivational interviewing

Abstinence reinforcement

Drug testing BEHAVIORAL

Self-performed salivary drug testing with incentives contingent upon proper completion of test procedures as confirmed by video.

Sample-contingent control

Wellness modules BEHAVIORAL

Basic health and wellness information delivered via self-paced learning modules.

Sample-contingent control

Peer technical support BEHAVIORAL

Peer support for promoting engagement and addressing technical issues delivered via a mobile digital platform.

Sample-contingent control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Michigan University: lead
• DynamiCare Health Inc.: collaborator
• RTI International: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Western Michigan University

Kalamazoo, Michigan, 49008, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Investigators who have no direct contact with study participants will communicate directly with information technology (IT) staff to assign participants to one of the two study groups. Participants will be blind to hypothesis, and outcome assessors will be completely blind. Care providers (i.e., "Contingency Management \[CM\] Guides") cannot be blind because modified scripts are required for their interactions with participants depending on group assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 18, 2023
• Study Start: April 23, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available upon approval of manuscript describing main study outcomes in a peer reviewed scientific journal. Data will remain on openICPSR indefinitely.
• Access Criteria: Anyone.

Locations

US (1)