Opioid Use DisorderMIAPPNCT06027814
MHealth Incentivized Adherence Plus Patient Navigation
A study testing Patient Navigation and mHealth (PN+mHealth) in people with Opioid Use Disorder and Medication Adherence, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Medication Adherence, Polysubstance Drug Use (Indiscriminate Drug Use)
- What is being tested?
- Patient Navigation and mHealth (PN+mHealth)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2024to 13 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official 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
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.
- Conditions
- Opioid Use Disorder, Medication Adherence, Polysubstance Drug Use (Indiscriminate Drug Use), Methamphetamine-dependence
- Being tested
- Patient Navigation and mHealth (PN+mHealth)
- Medical subject headings
- Opioid-Related Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation and mHealth (PN+mHealth)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual (TAU) | No 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. |
| PN+mHealth | Experimental | 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. Receives: Behavioral: Patient Navigation and mHealth (PN+mHealth) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post-discharge from hospital
Secondary outcomes (5)
Retention on Medication for Opioid Use Disorder
This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).
Measured: 90 days post-discharge from hospital
Hospital Readmission
The number of hospital admissions will be extracted from statewide Medicaid claims data.
Measured: 90 days post-discharge from hospital
Emergency Department Visits
The number of emergency department visits will be extracted from statewide Medicaid claims data.
Measured: 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.
Measured: 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.
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start3 Jan 2024
- Primary completion14 Apr 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Judith I. Tsui, University of Washington
- Investigators
- Judith I Tsui, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027814
- Sponsor's protocol ID
- STUDY00016329
- Other IDs
- 1R34DA057609-01
- Acronym
- MIAPP
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2023
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhatraju EP, Zinsli KA, Kennedy DN, Gojic AJ, Iles-Shih M, Merrill JO, Speaker EC, Samet JH, Hallgren KA, Tsui JI. Patient Navigation Plus mHealth Incentives for Linkage to OUD Care for Adults Who Also Use Methamphetamines: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2638542. doi: 10.1001/jamanetworkopen.2026.38542.
PubMed 42867864Bhatraju 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.
PubMed 39881397
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06027814
- Acronym / sponsor ID
- MIAPP / STUDY00016329
- Conditions
- Opioid Use Disorder, Medication Adherence, Polysubstance Drug Use (Indiscriminate Drug Use), Methamphetamine-dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Posted 27 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual (TAU) | No 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. |
| PN+mHealth | Experimental | Behavioral: Patient Navigation and mHealth (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | PN+mHealth |
Primary outcome
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.
5 secondary outcomes
Retention on Medication for Opioid Use Disorder
Time frame: 90 days post-discharge from hospital
Hospital Readmission
Time frame: 90 days post-discharge from hospital
Emergency Department Visits
Time frame: 90 days post-discharge from hospital
Past 30-day Opioid Use
Time frame: 30 days post-discharge
Past 30-day Methamphetamine Use
Time frame: 30 days post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42867864Bhatraju EP, Zinsli KA, Kennedy DN, Gojic AJ, Iles-Shih M, Merrill JO, Speaker EC, Samet JH, Hallgren KA, Tsui JI. Patient Navigation Plus mHealth Incentives for Linkage to OUD Care for Adults Who Also Use Methamphetamines: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2638542. doi: 10.1001/jamanetworkopen.2026.38542.
- Derived from this study: PubMed 39881397Bhatraju 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith I Tsui, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation and mHealth (PN+mHealth) in people with Opioid Use Disorder and Medication Adherence, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Linkage to an Outpatient Program That Provides Medication for Opioid Use Disorder (time frame: 30 days post-discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027814, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.