Smartphone App for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Western Michigan University
Must be taking: Medication assisted treatment
Disqualifiers: Alcohol use disorder, Incarceration, Suicidal ideation, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have started or be willing to start medication-assisted treatment for opioid use disorder.
What data supports the effectiveness of the treatment Smartphone App for Opioid Use Disorder?
Research shows that mobile apps can help people understand and use medication-assisted treatment (MAT) for opioid use disorder more effectively. Apps like MySafeRx and uMAT-R have been found to be useful and acceptable for people in treatment, providing support and information that can improve treatment outcomes.
12345Is the smartphone app for opioid use disorder safe for humans?
A study evaluated the safety of a digital therapeutic used alongside buprenorphine for treating opioid use disorder, suggesting it is generally safe for humans.
13567How is the Smartphone App for Opioid Use Disorder treatment different from other treatments?
The Smartphone App for Opioid Use Disorder is unique because it provides a digital, low-cost, and accessible way to support recovery by offering scientifically-backed health information and addressing common misconceptions about medication-assisted treatment (MAT), which can be barriers to treatment entry.
15689Eligibility Criteria
This trial is for adults over 18 in the U.S. who have opioid use disorder, can read and speak English, own a compatible smartphone, and have used opioids recently. They should be starting or already receiving medication-assisted treatment and have an ASAM CO-Triage score from L1 to L3.1.Inclusion Criteria
I am 18 years old or older.
I am willing to start or have started medication-assisted treatment in the last 45 days.
Must have an ASAM CO-Triage score between L1 and L3.1
+5 more
Exclusion Criteria
Is currently enrolled in another study involving substance abuse treatment
Has concurrent alcohol use disorder
Is currently incarcerated
+1 more
Trial Timeline
Welcome Period
Participants complete the Welcome Period to learn the basics of the DynamiCare app and perform practice saliva tests.
2-4 weeks
1 orientation session (virtual)
Study Period
Participants use the smartphone app for self-monitoring and receive incentives for drug abstinence and treatment attendance.
48 weeks
Weekly video submissions, quarterly interviews (virtual)
Follow-up
Participants are monitored for safety and effectiveness after the main study period.
4 weeks
Participant Groups
The study tests if a smartphone app providing reminders, rewards, cognitive-behavior therapy modules, wellness activities, and live support helps people with opioid addiction. Participants submit weekly drug test videos for one year.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Abstinence reinforcementExperimental Treatment3 Interventions
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.
Group II: Sample-contingent controlPlacebo Group3 Interventions
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.
OUD Smartphone Services is already approved in United States for the following indications:
🇺🇸 Approved in United States as OUD Smartphone Services for:
- Opioid Use Disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Western Michigan UniversityKalamazoo, MI
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Who Is Running the Clinical Trial?
Western Michigan UniversityLead Sponsor
RTI InternationalCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
DynamiCare Health Inc.Collaborator
References
Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]Digital therapeutic tools (e.g. mobile applications) can be accessible, low-cost interventions that counter misconceptions about medication assisted treatment (MAT) and/or improve deficits in MAT knowledge that are common barriers to treatment entry among individuals with opioid dependence. The purpose of this pilot study was to examine the preliminary effectiveness of a mobile application, 'uMAT-R', that includes health information about OUD recovery supported by science and MAT benefits.
Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. [2023]Label="Background" NlmCategory="UNASSIGNED">Increasing buprenorphine/naloxone (B/N) access for opioid use disorder (OUD) is essential yet ensuring adherence and preventing diversion remains challenging. This study examines the feasibility, usability, and acceptability of MySafeRx, a mobile platform integrating motivational coaching, adherence monitoring, and electronic dispensing during office-based B/N treatment.
Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]To evaluate the safety and efficacy of a digital therapeutic in treatment-seeking individuals with opioid use disorder (OUD) in an analysis of randomized clinical trial (RCT) data (ClinicalTrials.gov identifier: NCT00929253).
Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. [2018]The deployment of health information technologies promises to optimize clinical outcomes for populations with substance use disorders. Electronic health records, web-based counseling interventions, and mobile phone applications enhance the delivery of evidence-based behavioral and pharmacological treatments, with minimal burden to clinical personnel, infrastructure, and work flows. This clinical case shares a recent experience utilizing mobile phone text messaging between an office-based buprenorphine provider in a safety net ambulatory clinic and a patient seeking buprenorphine treatment for opioid use disorder. The case highlights the use of text message-based physician-patient communication to facilitate unobserved "home" induction onto buprenorphine.
Listening to women and pregnant and postpartum people: Qualitative research to inform opioid use disorder treatment for pregnant and postpartum people. [2023]The diagnosis of Opioid Use Disorder (OUD) during pregnancy has increased 2-to-5-fold over the past decade and barriers to treatment are significant. Technology-based solutions have the potential to overcome these barriers and deliver evidence-based treatment. However, these interventions need to be informed by end-users. The goal of this study is to gain feedback from peripartum people with OUD and obstetric providers about a web-based OUD treatment program.
Identifying key risk factors for premature discontinuation of opioid use disorder treatment in the United States: A predictive modeling study. [2022]Treatment for opioid use disorder (OUD), particularly medication for OUD, is highly effective; however, retention in OUD treatment is a significant challenge. We aimed to identify key risk factors for premature exit from OUD treatment.
Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">A prescription digital therapeutic (PDT) (reSET-O®) may expand access to behavioral treatment for patients with opioid use disorder (OUD) treated with buprenorphine, but long-term data on effectiveness are lacking.
A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study. [2021]Opioid use disorder (OUD) is a public health crisis with more than 2 million people living with OUD in the United States. Medication-assisted treatment (MAT) is an evidence-based approach for the treatment of OUD that relies on a combination of behavioral therapy and medication. Less than half of those living with OUD are accessing this treatment. Mobile technology can enhance the treatment of chronic diseases in readily accessible and cost-effective ways through self-monitoring and support.
Perspectives of Patients Receiving Telemedicine Services for Opioid Use Disorder Treatment: A Qualitative Analysis of User Experiences. [2023]Telemedicine for opioid use disorder (tele-OUD) has the potential to increase access to medications for OUD (MOUD). Fully virtual tele-OUD services, in which all care is provided via telemedicine, are increasingly common, yet few studies document the experiences of patients who use such services. Understanding patient perspectives is one of multiple considerations to inform the regulation and reimbursement of tele-OUD services.