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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Polysubstance use involving opioids and methamphetamine is emerging as a new public health crisis. Patients with opioids and methamphetamine use often experience serious medical complications requiring hospitalization, which provides an opportunity to offer addiction treatment. Yet linkage to outpatient treatment post-discharge is suboptimal and methamphetamine exacerbates outcomes. The investigators propose to pilot test "MHealth Incentivized Adherence Plus Patient Navigation" (MIAPP) to promote treatment linkage and retention for patients with opioid use disorder (OUD) and methamphetamine use who initiate buprenorphine in the hospital. The investigators Aim is to perform a two-arm, pilot randomized clinical trial (n=40) comparing MIAPP + treatment-as-usual (TAU) versus TAU alone on outpatient medication for opioid use disorder (MOUD) linkage within 30 days (primary) and 90-day retention on medications (secondary) among hospitalized patients with OUD and methamphetamine use.

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 data supports the idea that Incentivized Adherence + Patient Navigation for Opioid Use Disorder is an effective treatment?

The available research shows that using smartphone-based platforms to support treatment for opioid use disorder can be effective. For example, one study found that a smartphone-smartcard platform increased attendance at counseling appointments by 9.6% to 18% and improved drug abstinence and medication adherence compared to a control group. Another study showed that a smartphone app for contingency management helped 100% of participants stay in buprenorphine treatment, with a 76% adherence rate. These findings suggest that using technology to incentivize adherence and provide patient navigation can improve treatment outcomes for opioid use disorder. ^{1 2 3 4 5}

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

Research shows that using smartphone apps for contingency management (reward-based strategies) can significantly improve medication adherence and drug abstinence in people with opioid use disorder. Additionally, video-assisted dosing and secure medication dispensers have been shown to increase treatment retention by reducing travel barriers. ^{1 2 3 4 5}

What safety data exists for the treatment involving incentivized adherence and patient navigation for opioid use disorder?

The available research primarily focuses on the feasibility, acceptability, and preliminary efficacy of smartphone-based interventions for promoting adherence to buprenorphine treatment in opioid use disorder. Studies have shown that these interventions are feasible and well-received by participants, with high rates of adherence and retention. However, specific safety data for the treatment known as Incentivized Adherence + Patient Navigation or MIAPP is not directly addressed in the provided research. Further evaluation in randomized controlled trials is suggested to assess efficacy and safety comprehensively. ^{1 3 4 5 6}

Is the Incentivized Adherence + Patient Navigation treatment safe for humans?

The studies reviewed focus on smartphone-based interventions to improve medication adherence for opioid use disorder, which are generally well-received and feasible, with no specific safety concerns reported. Participants successfully used the app features and remained in treatment, suggesting the approach is safe for human use. ^{1 3 4 5 6}

Is the treatment MIAPP a promising treatment for opioid use disorder?

Yes, MIAPP is promising because it combines patient navigation, which helps people stick to their treatment, with incentives to encourage adherence. This approach can improve engagement and retention in treatment, making it more likely for people to successfully manage their opioid use disorder. ^{1 4 5 6 7}

How is the MIAPP treatment different from other treatments for opioid use disorder?

The MIAPP treatment is unique because it combines mobile health technology with incentives to encourage medication adherence and patient navigation to guide individuals through their treatment journey, which is not commonly found in standard opioid use disorder treatments. ^{1 4 5 6 7}

Research Team

Judith I Tsui, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A smartphone-smartcard platform for contingency management in an inner-city substance use disorder outpatient program. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone-Based Contingency Management Intervention for Buprenorphine Adherence. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Do out-of-pocket costs influence retention and adherence to medications for opioid use disorder? [2022]

5. England pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]

6. Netherlands 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. [2023]