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MHealth Incentivized Adherence Plus Patient Navigation

NCT ID: NCT06027814

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-03

Study Completion Date

2026-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use Disorder Medication Adherence Polysubstance Drug Use (Indiscriminate Drug Use) Methamphetamine-dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to treatment group. Group assignment will occur through computerized (REDCap) randomization procedures. The investigators will stratify randomization by whether the patient has buprenorphine treatment in the past year. Randomization lists will be prepared within each stratum using random block sizes of 4 to ensure balanced groups throughout the enrollment period. Participants will be informed of their assignment by research staff after completion of informed consent and the baseline survey.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment-as-usual (TAU)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

PN+mHealth

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 Type EXPERIMENTAL

Patient Navigation and mHealth (PN+mHealth)

Intervention Type 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.

Interventions

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Patient Navigation and mHealth (PN+mHealth)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Judith I. Tsui

Professor, School of Medicine, General Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith I Tsui, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Bhatraju EP, Kennedy DN, Gojic AJ, Iles-Shih M, Merrill JO, Samet JH, Hallgren KA, Tsui JI. mHealth Incentivized Adherence Plus Patient Navigation (MIAPP): protocol for a pilot randomized controlled trial to improve linkage and retention on buprenorphine for hospitalized patients with methamphetamine use and opioid use disorder. Addict Sci Clin Pract. 2025 Jan 29;20(1):6. doi: 10.1186/s13722-025-00538-1.

Reference Type DERIVED
PMID: 39881397 (View on PubMed)

Other Identifiers

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1R34DA057609-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00016329

Identifier Type: -

Identifier Source: org_study_id