An interventional study of Patient Navigation and mHealth (PN+mHealth) in Opioid Use Disorder, Medication Adherence and Polysubstance Drug Use (Indiscriminate Drug Use), sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 40 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Behavioral: 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.
Patient Linkage to an Outpatient Program That Provides Medication for Opioid Use Disorder
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.
Time frame: 30 days post-discharge from hospital
Retention on Medication for Opioid Use Disorder
This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).
Time frame: 90 days post-discharge from hospital
Hospital Readmission
The number of hospital admissions will be extracted from statewide Medicaid claims data.
Time frame: 90 days post-discharge from hospital
Emergency Department Visits
The number of emergency department visits will be extracted from statewide Medicaid claims data.
Time frame: 90 days post-discharge from hospital
Past 30-day Opioid Use
The number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index.
Time frame: 30 days post-discharge
Past 30-day Methamphetamine Use
The number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index.
Time frame: 30 days post-discharge
This study enrolled 40 participants between January 3, 2024, and January 7, 2025. The study took place at a single, large urban safety net hospital in Seattle, Washington, which serves as a level 1 trauma hospital.
| Milestone | Treatment-as-usual (TAU) | PN+mHealth |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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.
| Participants | Treatment-as-usual (TAU) | PN+mHealth |
|---|---|---|
| Patient Linkage to an Outpatient Program That Provides Medication for Opioid Use Disorder | 10 | 11 |
This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).
| Days | Treatment-as-usual (TAU) | PN+mHealth |
|---|---|---|
| Retention on Medication for Opioid Use Disorder | 23.9 ± 26.6 | 18.7 ± 19.3 |
The number of hospital admissions will be extracted from statewide Medicaid claims data.
| Hospital Admission Events | Treatment-as-usual (TAU) | PN+mHealth |
|---|---|---|
| Hospital Readmission | 0.9 ± 1.3 | 0.1 ± 0.3 |
The number of emergency department visits will be extracted from statewide Medicaid claims data.
| Visits | Treatment-as-usual (TAU) | PN+mHealth |
|---|---|---|
| Emergency Department Visits | 0.7 ± 1.1 | 0.4 ± 1.0 |
The number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index.
| Days | Treatment-as-usual (TAU) | PN+mHealth |
|---|---|---|
| Past 30-day Opioid Use | 3.7 ± 8.6 | 4.7 ± 7.2 |
The number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index.
| Days | Treatment-as-usual (TAU) | PN+mHealth |
|---|---|---|
| Past 30-day Methamphetamine Use | 5.8 ± 11.4 | 4.8 ± 7.6 |
Collected over From enrollment until end of follow-up assessment, up to 120 days post-discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment-as-usual (TAU) | 0/20 (0%) | 11/20 (55%) | 5/20 (25%) |
| PN+mHealth | 0/20 (0%) | 3/20 (15%) | 3/20 (15%) |
| Event | Treatment-as-usual (TAU) | PN+mHealth |
|---|---|---|
| HospitalizationGeneral disorders | 11/20 | 3/20 |
| Event | Treatment-as-usual (TAU) | PN+mHealth |
|---|---|---|
| Emergency Department AdmissionsGeneral disorders | 5/20 | 1/20 |
| Urgent Care VisitGeneral disorders | 0/20 | 1/20 |
| Outpatient ProcedureGeneral disorders | 0/20 | 1/20 |
| Age, Continuous(Years) | Treatment-as-usual (TAU) | PN+mHealth | Total |
|---|---|---|---|
| Mean | 45.7 ± 13.2 | 41.2 ± 11.9 | 43.4 ± 12.6 |
| Sex: Female, Male(Participants) | Treatment-as-usual (TAU) | PN+mHealth | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 17 | 16 | 33 |
| Race/Ethnicity, Customized(Participants) | Treatment-as-usual (TAU) | PN+mHealth | Total |
|---|---|---|---|
| Hispanic | 4 | 1 | 5 |
| Non-Hispanic American Indian/Alaska Native | 1 | 0 | 1 |
| Non-Hispanic Asian | 2 | 2 | 4 |
| Non-Hispanic Black/African American | 4 | 1 | 5 |
| Non-Hispanic White | 9 | 16 | 25 |
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