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Active, Not Recruiting

NCT Number: NCT06027814

MHealth Incentivized Adherence Plus Patient Navigation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Opioid Use Disorder Behavior Chemically-Induced Disorders Health Behavior Medication Adherence Mental Disorders Methamphetamine-dependence Narcotic-Related Disorders Opioid-Related Disorders Patient Acceptance of Health Care Patient Compliance Polysubstance Drug Use (Indiscriminate Drug Use) Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult greater than or equal to 18 years of age
  • Admitted to Harborview Medical Center (HMC) on any inpatient service
  • Initiated on buprenorphine for OUD while in the hospital or at the time of discharge and planning to continue outpatient
  • Used methamphetamine within the past 30 days (any route of administration or frequency)
  • Willing to be randomized to video-DOT
  • Willing and able to use a smartphone (study can provide) and work with patient navigator
  • Discharge setting does not preclude the use of video-DOT (i.e., nursing home, inpatient psychiatry, etc.)

Exclusion criteria

  • Unable or unwilling to use smartphone (phones to be provided when needed)
  • Cognitive impairment (acute or chronic) resulting in inability to provide informed consent
  • Currently incarcerated and will discharge to jail or prison
  • Plans to discontinue buprenorphine in the near future (<3 months)
  • Lives far away such that cannot keep study visit at 30 days post-discharge
  • Not English speaking
  • Behavioral risk per discretion of research staff

Treatment and study plan

Patient Navigation and mHealth (PN+mHealth)

Behavioral

Intervention consists of patient navigation with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone.

Primary outcomes

  1. Patient Linkage to an Outpatient Program That Provides Medication for Opioid Use Disorder

    Time frame: 30 days post-discharge from hospital

    Defined as documentation of an outpatient clinical encounter (either in-person or via telemedicine) where a medication for OUD (either buprenorphine, naltrexone, or methadone) was provided or prescribed.

Secondary outcomes

  1. Retention on Medication for Opioid Use Disorder

    Time frame: 90 days post-discharge from hospital

    This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).

  2. Hospital Readmission

    Time frame: 90 days post-discharge from hospital

    The number of hospital admissions will be extracted from statewide Medicaid claims data.

  3. Emergency Department Visits

    Time frame: 90 days post-discharge from hospital

    The number of emergency department visits will be extracted from statewide Medicaid claims data.

  4. Past 30-day Opioid Use

    Time frame: 30 days post-discharge

    The number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index.

  5. Past 30-day Methamphetamine Use

    Time frame: 30 days post-discharge

    The number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Patient Navigator Plus Remote mHealth Adherence Support With Incentives to Improve Linkage and Retention Among Hospitalized Patients With Opioid and Methamphetamine Use Who Initiate Buprenorphine

Acronym: MIAPP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 7, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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