Incentivized Adherence + Patient Navigation for Opioid Use Disorder

(MIAPP Trial)

Overseen By Research Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: Buprenorphine

Disqualifiers: Cognitive impairment, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach, called MHealth Incentivized Adherence Plus Patient Navigation, to assist individuals with opioid use disorder (OUD) who also use methamphetamine in adhering to their treatment plan after hospital discharge. The study compares two groups: one receives usual care, while the other receives additional support through a smartphone app and a patient navigator, who guides treatment. The goal is to determine if this extra support improves adherence to medication plans. Individuals who have started taking buprenorphine for OUD in the hospital and have used methamphetamine in the last 30 days may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative support methods that could enhance the treatment experience.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves starting buprenorphine, it's best to discuss your current medications with the trial staff or your doctor.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves starting buprenorphine for opioid use disorder, it's best to discuss your current medications with the trial staff or your doctor.

What prior data suggests that the MIAPP protocol is safe for patients with opioid use disorder and methamphetamine use?

Research shows that the MHealth Incentivized Adherence Plus Patient Navigation (MIAPP) treatment helps people follow their medication plans and connect to outpatient care. This treatment uses a mobile health (mHealth) app to support patients with opioid use disorder (OUD) and methamphetamine use.

The safety of this approach stems from its design. It includes a patient navigator who assists patients through online visits and two-way chats. Patients also upload videos to confirm they are taking their medications as prescribed. This system combines with financial rewards to encourage adherence to the treatment plan.

While no direct safety data exists from the studies, the method is non-invasive, meaning it is unlikely to cause physical harm because it uses digital tools and support instead of new medications.

Prospective participants should know that buprenorphine, a medication often used in these treatments, has FDA approval for treating opioid use disorder. This approval indicates that the medication part of the program has a known safety profile. However, discussing with a healthcare provider is crucial to understand how it might work for individual situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines technology and personal support to tackle opioid use disorder (OUD) in a new way. The treatment uses a mobile health (mHealth) app alongside patient navigation to boost medication adherence. This approach is distinctive because it offers telehealth visits, two-way communication, and video directly observed therapy (video-DOT) via smartphone. Additionally, the program incentivizes patients financially for sticking to their medication schedule and connecting with outpatient treatment within 30 days, adding a motivational layer that's not typically part of standard care. By integrating these elements, researchers hope to improve adherence and recovery outcomes more effectively than traditional methods alone.

What evidence suggests that MIAPP is effective for opioid use disorder?

Research has shown that the MHealth Incentivized Adherence Plus Patient Navigation (MIAPP) program, which participants in this trial may receive, benefits people with opioid use disorder (OUD), especially those also using methamphetamine. Studies have found that this approach helps patients adhere to their treatment plans by connecting them to outpatient care and supporting them to stay on medications like buprenorphine for longer. MIAPP combines technology, such as smartphone apps, with personal support from patient navigators to facilitate treatment adherence. Early findings suggest that patients using MIAPP are more likely to attend follow-up appointments and take their medication as prescribed. This combination of tools and support has shown promise in keeping people engaged in their recovery journey. ^{1 2 3 4 5}

Who Is on the Research Team?

Judith I Tsui, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are hospitalized at Harborview Medical Center, have used methamphetamine in the last 30 days, and started or plan to continue buprenorphine treatment for opioid use disorder after discharge. Participants must be willing to use a smartphone and work with a patient navigator.

Inclusion Criteria

Admitted to Harborview Medical Center (HMC) on any inpatient service

Discharge setting does not preclude the use of video-DOT (i.e., nursing home, inpatient psychiatry, etc.)

I started buprenorphine for opioid use disorder in the hospital and plan to continue it.

Exclusion Criteria

Lives far away such that cannot keep study visit at 30 days post-discharge

Unable or unwilling to use smartphone (phones to be provided when needed)

Currently incarcerated and will discharge to jail or prison

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive patient navigation and mHealth support in addition to treatment-as-usual, including telehealth visits, two-way chats, video-DOT, and financial incentives for adherence and linkage to outpatient treatment

30 days

Daily video uploads, telehealth visits

Follow-up

Participants are monitored for linkage to outpatient treatment and retention on medication for opioid use disorder

90 days

What Are the Treatments Tested in This Trial?

Interventions

• MHealth Incentivized Adherence Plus Patient Navigation

Trial Overview The study tests 'MHealth Incentivized Adherence Plus Patient Navigation' (MIAPP) combined with usual care versus usual care alone. It aims to improve linkage to outpatient treatment and retention on medication for opioid use disorder among patients also using methamphetamine.

How Is the Trial Designed?

Group I: PN+mHealth Experimental Treatment 1 Intervention

The intervention is patient navigation and mHealth in addition to treatment-as-usual. The intervention consists of a patient navigator (PN) with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone for adherence and linkage to outpatient treatment within 30 days. Participants will be asked to upload medication adherence videos once a day over the 30 days post discharge from the hospital. Patients will be instructed to continue to take their medication as prescribed in any circumstance where they are unable to upload the video for any reason.

Group II: Treatment-as-usual (TAU) Active Control 1 Intervention

TAU will be usual care that the Addiction Consult Service provides. It is comprised of a multidisciplinary team of professionals, including addiction medicine and addiction psychiatry physicians, nurses specializing in the treatment of OUD, substance use disorder counselors, peer recovery supports, and program coordinators.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A pilot study involving 58 adults in a Vermont opioid treatment program demonstrated that a video directly observed therapy (VDOT) app combined with a secure medication dispenser led to 98.4% compliance in medication ingestion, with only a minimal rate of noncompliance.

Participants experienced significant reductions in travel time and costs (86% reduction), saving a median of $72 weekly and 5.5 hours of travel time, while maintaining a high retention rate of 98% in treatment after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing the Clinical use of a Novel Video-assisted Dosing Protocol With Secure Medication Dispensers to Reduce Barriers to Opioid Treatment. Brooklyn, JR., Stothart, M., Stunell, M., et al.[2022]

A study of 6,439 adults with commercial insurance found that for every one dollar increase in daily out-of-pocket cost for buprenorphine, there was a 12-14% decrease in treatment retention and a 5-8% increase in days without medication coverage.

Despite lower average out-of-pocket costs for buprenorphine compared to two decades ago, these costs still negatively impact retention and adherence to treatment for opioid use disorder, indicating a need for policies that address patient cost-sharing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do out-of-pocket costs influence retention and adherence to medications for opioid use disorder? Dunphy, C., Peterson, C., Zhang, K., et al.[2022]

Patient navigation (PN) significantly improved treatment adherence and engagement in opioid use disorder (OUD) among pregnant individuals, with better outcomes in medication use and substance use disorder treatment attendance compared to usual care (UC).

The pilot study, involving 102 pregnant participants, demonstrated that those receiving PN had fewer reported overdoses at 2 and 6 months postpartum, suggesting that PN may enhance safety and effectiveness in managing OUD during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. Cochran, G., Smid, MC., Krans, EE., et al.[2023]

The integrated smartphone-smartcard platform significantly improved counseling appointment attendance and drug abstinence rates among 85 adults with opioid use disorder over a four-month period, showing a 9.6%-18.0% increase in attendance and an odds ratio of 4.84 for drug abstinence compared to matched controls.

Participants overwhelmingly found the platform acceptable, indicating that this technology could help overcome barriers to the adoption of contingency management (CM) interventions in treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-smartcard platform for contingency management in an inner-city substance use disorder outpatient program. DeFulio, A., Rzeszutek, MJ., Furgeson, J., et al.[2021]

A study involving 20 participants over 12 weeks demonstrated that smartphone-based contingency management effectively promoted adherence to buprenorphine treatment, achieving a 76% confirmed adherence rate.

All participants remained in treatment throughout the study, and they reported high satisfaction with the app, indicating that this approach could be a practical solution for improving medication adherence in opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone-Based Contingency Management Intervention for Buprenorphine Adherence. DeFulio, A., Brown, HD., Davidson, RM., et al.[2023]

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

A study is being conducted to evaluate the effectiveness of a smartphone app called OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), specifically targeting individuals in outpatient settings.

The trial will compare two groups: one receiving standard MAT and the other receiving MAT with the OptiMAT app, assessing opioid misuse through urinalysis over a 6-month period, which could lead to better treatment strategies in rural areas heavily affected by the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, MJ., et al.[2023]

Citations

1. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-025-00538-1

mHealth Incentivized Adherence Plus Patient Navigation ... Secondary outcomes include retention on buprenorphine 90 days post discharge, hospital readmissions, and past 30-day methamphetamine use.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39881397/

protocol for a pilot randomized controlled trial to improve ... We will examine the MIAPP intervention to improve buprenorphine adherence and linkage to outpatient treatment in a pilot randomized controlled trial.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11780921/

mHealth Incentivized Adherence Plus Patient Navigation ( ... Secondary outcomes include retention on buprenorphine 90 days post discharge, hospital readmissions, and past 30-day methamphetamine use.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06027814

MHealth Incentivized Adherence Plus Patient Navigation Primary Outcome Measures. Outcome Measure, Measure Description, Time Frame. Patient linkage to an outpatient program that provides medication for opioid use ...

5. withpower.com withpower.com/trial/phase-opioid-related-disorders-8-2023-0db2d

Incentivized Adherence + Patient Navigation for Opioid ... What data supports the effectiveness of the treatment MHealth Incentivized Adherence Plus Patient Navigation (MIAPP) for opioid use disorder? Research shows ...