Opioid Use DisordermPeer4LifeNCT07900828
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
A study testing Mobile phone-assisted intervention and Peer navigator in people with Opioid Use Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is the third phase of the mPeer4Life study - the Trial Phase, will be evaluating the intervention that was developed based on the Formative and Pilot Phases. The study population are patients transitioning from the Emergency Department (ED) or hospital to outpatient Medication Assisted Treatment (MAT). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Mobile phone-assisted intervention and Peer navigator
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Opioid use-related ED or hospital encounter within one month of enrollment
- Self-report or documented illegal opioid drug use or prescription opioid misuse within one month of seeking care at ED or hospital
Who cannot join
- Non-English speaking
- Unwilling to adhere to study procedures
- Significant cognitive or auditory impairment that prevents proper completion of study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Oluwaseun Falade-Nwulia, MBBS, MPH, 410-550-6234, ofalade1@jhmi.edu
Oluwaseun Falade-Nwulia, MBBS, MPH, 4105506234, ofalade1@jhmi.edu
About this study
Official title: mPeer4Life: A Peer-led, Mobile Health-supported, Narrative-based Intervention to Enhance Linkage and Engagement in Medication Assisted Treatment (MAT) for Patients With Opioid Use Disorder (OUD)
This is the third phase of the mPeer4Life study - the Trial Phase, will be evaluating the intervention that was developed based on the Formative and Pilot Phases. The study population are patients transitioning from the Emergency Department (ED) or hospital to outpatient Medication Assisted Treatment (MAT). The RCT will consist of three arms (1:1:1) with 30 participants in each arm:
- Arm 1 will include a peer navigator + mobile phone-assisted intervention
- Arm 2 will have a peer navigator only
- Arm 3 will follow the standard of care referral for MAT linkage All patient-level participants will complete baseline and exit interviews, which will evaluate current drug use behaviors, medical history, and OUD treatment engagement status.
Read the detailed description
The mPeer4Life study tests a peer-based, narrative-driven, mobile phone-assisted intervention to improve linkage to outpatient OUD treatment for patients transitioning from the ED or hospital to MAT. It has three phases: formative, pilot, and trial. The formative phase used interviews with patients, providers, and staff to identify barriers, facilitators, and preferred intervention features. The pilot phase tested usability and helped refine protocols, SOPs, visit schedules, and data forms. A mobile app - the mHealth application and website will provide recovery narratives, peer text support, motivational messages, appointment reminders, medication adherence support, and resources such as housing, employment, self-help groups, safe injection practices, and overdose prevention.
This is the final phase of the study; a randomized controlled trial that will have 30 enrolled participants in each of the three arms:
Arm 1: Peer Navigator + mobile app Arm 2: Peer Navigator only Arm3: Standard of Care referral for MAT linkage.
Participants without phones will receive a study phone with a 3-month prepaid plan. Peer navigators will receive specialized training and support participants in the first two arms. The standard care arm will not receive the app or a peer navigator. The 3-month trial includes two study visits: baseline and exit, during which participants will complete interviews that evaluate current drug use behaviors, medical history, and OUD treatment engagement status.
- Conditions
- Opioid Use Disorder
- Being tested
- Mobile phone-assisted intervention, Peer navigator, Standard of care referral for out-patient MAT
- Keywords
- peer support, mobile app, OUD care linkage
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone-assisted interventionBehavioural
Enrolled study participants transitioning from the ED or hospital to outpatient MAT will be given 3-month access to the use of a mobile phone App developed from information gathered during the formative and pilot phases of the study. The mobile phone app components will include text-based counseling and motivational messaging, appointment reminders, and medication adherence support. It will host resources (including geo-location) to ease access to other social determinants of OUD treatment (MAT) engagement, such as housing, employment, self-help group meeting locations and times, and highlight safe injection and overdose prevention. The intervention will be created to protect confidentiality: the format will not identify the participant as someone with OUD and information will be stored securely.
Peer navigatorBehavioural
Study peer navigators will be asked to participate and will undergo extensive training using the curriculum that has been informed by the previous phases. These peer navigators will provide support to patients transitioning from the ED or hospital to outpatient MAT.
Standard of care referral for out-patient MATBehavioural
Standard of care referral for out-patient MAT care given by the site when patients are transitioning from the ED or inpatient.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Peer navigator + mobile phone-assisted intervention | Experimental | Enrolled study participants randomized to this arm will proceed with the standard of care referral for MAT linkage at the study site and also be given a) access to the mobile App intervention for use in the three months period from randomization, as the participant transitions from the ED or hospital to outpatient MAT; b) a study-assigned Peer Navigator who will provide support for linkage and engagement in MAT care over the three months. Receives: Behavioral: Mobile phone-assisted intervention; Behavioral: Peer navigator; Behavioral: Standard of care referral for out-patient MAT |
| Arm 2: Peer navigator only | Active comparator | Enrolled study participants in this arm will proceed with the standard of care referral for MAT linkage at the study site and also be given a study-assigned Peer Navigator who will provide support for linkage and engagement in the three months period from randomization, as the participant transitions from the ED or hospital to outpatient MAT. Receives: Behavioral: Peer navigator; Behavioral: Standard of care referral for out-patient MAT |
| Arm 3: Standard of Care only | Other | Enrolled study participants in this arm will proceed with the standard of care referral for MAT linkage at the study site. The participants will not have access to the mobile Health App intervention and will not be assigned a study Peer Navigator. Receives: Behavioral: Standard of care referral for out-patient MAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAT initiation at three months after randomization
Study participants who initiate MAT treatment in each arm
Measured: Up to 12 weeks post randomization
MAT engagement at three months after randomization
Study participants who remain on MAT at 3 months in each arm
Measured: Up to 12 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oluwaseun Falade-Nwulia, MBBS, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900828
- Sponsor's protocol ID
- IRB00220706
- Acronym
- mPeer4Life
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only non-confidential data collected to satisfy primary outcomes and study objectives will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mPeer4Life: A Peer-led, Mobile Health-supported, Narrative-based Intervention to Enhance Linkage and Engagement in Medication Assisted Treatment (MAT) for Patients With Opioid Use Disorder (OUD)
- ClinicalTrials.gov ID
- NCT07900828
- Acronym / sponsor ID
- mPeer4Life / IRB00220706
- Conditions
- Opioid Use Disorder
- Keywords
- peer support, mobile app, OUD care linkage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the third phase of the mPeer4Life study - the Trial Phase, will be evaluating the intervention that was developed based on the Formative and Pilot Phases. The study population are patients transitioning from the Emergency Department (ED) or hospital to outpatient Medication Assisted Treatment (MAT). The RCT will consist of three arms (1:1:1) with 30 participants in each arm:
- Arm 1 will include a peer navigator + mobile phone-assisted intervention
- Arm 2 will have a peer navigator only
- Arm 3 will follow the standard of care referral for MAT linkage All patient-level participants will complete baseline and exit interviews, which will evaluate current drug use behaviors, medical history, and OUD treatment engagement status.
Detailed description
The mPeer4Life study tests a peer-based, narrative-driven, mobile phone-assisted intervention to improve linkage to outpatient OUD treatment for patients transitioning from the ED or hospital to MAT. It has three phases: formative, pilot, and trial. The formative phase used interviews with patients, providers, and staff to identify barriers, facilitators, and preferred intervention features. The pilot phase tested usability and helped refine protocols, SOPs, visit schedules, and data forms. A mobile app - the mHealth application and website will provide recovery narratives, peer text support, motivational messages, appointment reminders, medication adherence support, and resources such as housing, employment, self-help groups, safe injection practices, and overdose prevention.
This is the final phase of the study; a randomized controlled trial that will have 30 enrolled participants in each of the three arms:
Arm 1: Peer Navigator + mobile app Arm 2: Peer Navigator only Arm3: Standard of Care referral for MAT linkage.
Participants without phones will receive a study phone with a 3-month prepaid plan. Peer navigators will receive specialized training and support participants in the first two arms. The standard care arm will not receive the app or a peer navigator. The 3-month trial includes two study visits: baseline and exit, during which participants will complete interviews that evaluate current drug use behaviors, medical history, and OUD treatment engagement status.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Peer navigator + mobile phone-assisted intervention | Experimental | Behavioral: Mobile phone-assisted intervention, Behavioral: Peer navigator, Behavioral: Standard of care referral for out-patient MATEnrolled study participants randomized to this arm will proceed with the standard of care referral for MAT linkage at the study site and also be given a) access to the mobile App intervention for use in the three months period from randomization, as the participant transitions from the ED or hospital to outpatient MAT; b) a study-assigned Peer Navigator who will provide support for linkage and engagement in MAT care over the three months. |
| Arm 2: Peer navigator only | Active comparator | Behavioral: Peer navigator, Behavioral: Standard of care referral for out-patient MATEnrolled study participants in this arm will proceed with the standard of care referral for MAT linkage at the study site and also be given a study-assigned Peer Navigator who will provide support for linkage and engagement in the three months period from randomization, as the participant transitions from the ED or hospital to outpatient MAT. |
| Arm 3: Standard of Care only | Other | Behavioral: Standard of care referral for out-patient MATEnrolled study participants in this arm will proceed with the standard of care referral for MAT linkage at the study site. The participants will not have access to the mobile Health App intervention and will not be assigned a study Peer Navigator. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Opioid use-related ED or hospital encounter within one month of enrollment
- Self-report or documented illegal opioid drug use or prescription opioid misuse within one month of seeking care at ED or hospital
Key exclusion criteria (3 listed)
- Non-English speaking
- Unwilling to adhere to study procedures
- Significant cognitive or auditory impairment that prevents proper completion of study procedures
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 |
|---|---|---|
| Mobile phone-assisted interventionEnrolled study participants transitioning from the ED or hospital to outpatient MAT will be given 3-month access to the use of a mobile phone App developed from information gathered during the formative and pilot phases of the study. The mobile phone app components will include text-based counseling and motivational messaging, appointment reminders, and medication adherence support. It will host resources (including geo-location) to ease access to other social determinants of OUD treatment (MAT) engagement, such as housing, employment, self-help group meeting locations and times, and highlight safe injection and overdose prevention. The intervention will be created to protect confidentiality: the format will not identify the participant as someone with OUD and information will be stored securely. | Behavioural | Arm 1: Peer navigator + mobile phone-assisted intervention |
| Peer navigatorStudy peer navigators will be asked to participate and will undergo extensive training using the curriculum that has been informed by the previous phases. These peer navigators will provide support to patients transitioning from the ED or hospital to outpatient MAT. | Behavioural | Arm 1: Peer navigator + mobile phone-assisted intervention, Arm 2: Peer navigator only |
| Standard of care referral for out-patient MATStandard of care referral for out-patient MAT care given by the site when patients are transitioning from the ED or inpatient. | Behavioural | Arm 1: Peer navigator + mobile phone-assisted intervention, Arm 2: Peer navigator only, Arm 3: Standard of Care only |
Primary outcome
MAT initiation at three months after randomization
Time frame: Up to 12 weeks post randomization
Study participants who initiate MAT treatment in each arm
MAT engagement at three months after randomization
Time frame: Up to 12 weeks post randomization
Study participants who remain on MAT at 3 months in each arm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. Only non-confidential data collected to satisfy primary outcomes and study objectives will be shared.
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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.
Oluwaseun Falade-Nwulia, MBBS, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone-assisted intervention and Peer navigator in people with Opioid Use Disorder, run by Johns Hopkins University 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oluwaseun Falade-Nwulia, MBBS, MPH (4105506234, ofalade1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAT initiation at three months after randomization (time frame: Up to 12 weeks post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.