Opioid Use DisorderNCT07810322
Pilot Testing of the emPath Platform to Improve Medication for Opioid Use Disorder (MOUD) Linkage and Retention Among Adults With Opioid Use Disorder in Durham, North Carolina
A study testing emPath Intervention in people with Opioid Use Disorder and Digital Health Intervention, run by Duke University at 1 site in United States.
Trial summary
This pilot study will evaluate the emPath digital platform, a platform designed to improve access to and retention in low-barrier telemedicine for delivery of medication for opioid use disorder (MOUD) among adults with opioid use disorder who engage with community outreach programs in Durham, North Carolina. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Digital Health Intervention, Telemedicine
- What is being tested?
- emPath Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2026to 31 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Screen positive for moderate to high risk opioid use by WHO-ASSIST
- Not currently prescribed any form of MOUD
- Able to speak and understand English
- Able and willing to provide informed consent
- Age 18 or older
- Employed by the preceding 1 month or longer at time of enrollment
- Able and willing to provide informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amy Hobbie contact
United States1 site, 1 recruiting
- Recruiting
Project MAPS (Mobile Addiction Treatment and Primary Care Services)
Durham, North Carolina, 27703
Jacqueline Hodges, MD MPH, 919 681 1309, jacqueline.hodges@duke.edu
About this study
Official title: Pilot Testing of the emPath Intervention to Improve MOUD Linkage and Retention in Durham, NC
This pilot study will evaluate the emPath digital platform, a platform designed to improve access to and retention in low-barrier telemedicine for delivery of medication for opioid use disorder (MOUD) among adults with opioid use disorder who engage with community outreach programs in Durham, North Carolina.
Read the detailed description
This emPath pilot program will test the V1.0 app's core features (field-first app registration with access via personal device or a tablet stationed at community outreach sites, a secure telemedicine video visit portal designed for drop-in visits during outreach sessions, a secure in-app patient-provider messaging feature) combined with outreach staff facilitation at Project MAPS Durham mobile and fixed-site outreach sessions, to complete these aims:
Aim 1: Pilot the emPath prototype platform to initiate and maintain participants receiving community-based outreach services on all-virtual delivery of medications for opioid-use disorder (MOUD) using a low barrier care strategy.
Investigators will enroll up to 50 people with opioid use disorder for participation in the pilot program using a pilot feasibility-implementation trial. The primary feasibility outcome of interest is retention in care, defined by at least one virtual visit conducted before and after the expected 6-month time-point from enrollment.
Aim 2: Elucidate implementation determinants for the emPath pilot program. Study investigators will perform semi-structured qualitative interviews with up to 20 people who use drugs (PWUD) participants and 10 outreach staff participants to evaluate program implementation, as guided by Forney's conceptual framework for care access (PWUD) and the Consolidated Framework for Implementation Research (staff).
Researchers will use descriptive statistics to describe the baseline characteristics of the sample, including sociodemographics and substance use patterns (e.g., R). Retention defined as telemedicine visit attendance at baseline and before and after the 3 and/or 6-month follow-up time-point (whichever later timepoint is available based on when the participant was recruited) will be summarized with descriptive statistics following analysis of abstracted app paradata and electronic medical record data. As an exploratory question, there will be comparison of retention-in-care and secondary outcomes (e.g., participants who reported personal smartphone ownership at baseline vs not), as well as several baseline demographics (e.g., active injection drug use, housing status, criminal legal involvement in last year). Survey measures for implementation evaluation will be analyzed using descriptive statistics.
Side effects of buprenorphine/naloxone (Suboxone®) are rare and include headache, nausea, constipation, sweating, trouble sleeping, and numbness or pain in the mouth where a patient places the medication. More serious risks include breathing problems, especially if this medication is combined with alcohol, benzodiazepines (like Xanax or Valium), or other sedating drugs. Providers will regularly assess for these side effects during visits per standard of care. Participants will receive buprenorphine/naloxone medication (sublingual) at no added cost to themselves, in addition to related provider services during visits. Currently buprenorphine/naloxone (sublingual tablet formulation) is offered free of cost through a subsidy program for uninsured patients in Durham County, and also carries no associated co-pay for insured patients with Medicaid or Medicare (participants with other forms of insurance may be charged a co-pay). Long-acting injectable formulations will not be offered for this pilot study.
- Being tested
- emPath Intervention
- Keywords
- Opioid Use Disorder, Telemedicine, Medication for Opioid Use Disorder, mobile health app, Suboxone
- 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.
emPath InterventionBehavioural
Community-partnered telemedicine platform providing registration, video visits, messaging, and low-barrier MOUD access.
| Study group | Role | What they receive |
|---|---|---|
| emPath Intervention | Experimental | Participants receive access to the emPath telemedicine platform and virtual MOUD care. Receives: Behavioral: emPath Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility, as measured by retention in care
Retention in care is defined by at least one virtual visit conducted before and after the expected 3- or 6-month timepoint from enrollment, whichever later timepoint is available based on the participant's timing of enrollment during the study period.
Measured: up to 6 month visit
Secondary outcomes (5)
acceptability
Surveys (intervention acceptability, appropriateness, fidelity) Program participants and outreach staff will complete a 3 and 6-month follow-up assessment (if applicable) including additional validated survey tools for the implementation evaluation: the acceptability of intervention measure (AIM).
Measured: 3-month follow-up assessment via the AIM survey, ≤ 5 minutes to complete 6-month follow-up assessment (if applicable) via the AIM survey, ≤ 5 minutes to complete
appropriateness
Program participants and outreach staff will complete a 3 and 6-month follow-up assessment (if applicable) including additional validated survey tools for the implementation evaluation: the intervention appropriateness measure (IAM)
Measured: 3-month IAM assessment ≤ 5 minutes 6-month IAM assessment (if applicable) ≤ 5 minutes
intervention fidelity
To measure implementation protocol fidelity, staff will complete in a baseline survey and 6-month assessment several items related to their contributions to program activities, roles and responsibilities in relation to the implementation protocol.
Measured: Baseline survey ≤ 5 minutes 6-month survey ≤ 5 minutes
Intervention reach, as measured by weekly and monthly rates of participant platform feature engagement (dashboard, messaging, queue, video portal)
Measured: From enrollment through the end of the study period, up to 12 months
Intervention adoption, as measured by weekly and monthly rates of staff platform feature engagement (dashboard, messaging, queue, video portal)
Program participants and outreach staff will provide informed consent upon enrollment for abstraction of back-end platform paradata to analyze frequency of platform log-ins, usage patterns (messaging feature, telemedicine portal) and content of messaging feature. Participants will be counseled that no messaging content analyzed by the study team will be shared with others, including outreach staff, and will only be presented with pilot program findings for research purposes in aggregate form as counts by topic (e.g., medication management, eligibility navigation) or de-identified illustrative 'quotations.'
Measured: From enrollment through the end of the study period, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start29 Jul 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (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 Duke 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline Hodges, MD MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810322
- Sponsor's protocol ID
- Pro00120378
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of the emPath Intervention to Improve MOUD Linkage and Retention in Durham, NC
- ClinicalTrials.gov ID
- NCT07810322
- Acronym / sponsor ID
- Pro00120378
- Keywords
- Opioid Use Disorder, Telemedicine, Medication for Opioid Use Disorder, mobile health app, Suboxone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Sep 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 pilot study will evaluate the emPath digital platform, a platform designed to improve access to and retention in low-barrier telemedicine for delivery of medication for opioid use disorder (MOUD) among adults with opioid use disorder who engage with community outreach programs in Durham, North Carolina.
Detailed description
This emPath pilot program will test the V1.0 app's core features (field-first app registration with access via personal device or a tablet stationed at community outreach sites, a secure telemedicine video visit portal designed for drop-in visits during outreach sessions, a secure in-app patient-provider messaging feature) combined with outreach staff facilitation at Project MAPS Durham mobile and fixed-site outreach sessions, to complete these aims:
Aim 1: Pilot the emPath prototype platform to initiate and maintain participants receiving community-based outreach services on all-virtual delivery of medications for opioid-use disorder (MOUD) using a low barrier care strategy.
Investigators will enroll up to 50 people with opioid use disorder for participation in the pilot program using a pilot feasibility-implementation trial. The primary feasibility outcome of interest is retention in care, defined by at least one virtual visit conducted before and after the expected 6-month time-point from enrollment.
Aim 2: Elucidate implementation determinants for the emPath pilot program. Study investigators will perform semi-structured qualitative interviews with up to 20 people who use drugs (PWUD) participants and 10 outreach staff participants to evaluate program implementation, as guided by Forney's conceptual framework for care access (PWUD) and the Consolidated Framework for Implementation Research (staff).
Researchers will use descriptive statistics to describe the baseline characteristics of the sample, including sociodemographics and substance use patterns (e.g., R). Retention defined as telemedicine visit attendance at baseline and before and after the 3 and/or 6-month follow-up time-point (whichever later timepoint is available based on when the participant was recruited) will be summarized with descriptive statistics following analysis of abstracted app paradata and electronic medical record data. As an exploratory question, there will be comparison of retention-in-care and secondary outcomes (e.g., participants who reported personal smartphone ownership at baseline vs not), as well as several baseline demographics (e.g., active injection drug use, housing status, criminal legal involvement in last year). Survey measures for implementation evaluation will be analyzed using descriptive statistics.
Side effects of buprenorphine/naloxone (Suboxone®) are rare and include headache, nausea, constipation, sweating, trouble sleeping, and numbness or pain in the mouth where a patient places the medication. More serious risks include breathing problems, especially if this medication is combined with alcohol, benzodiazepines (like Xanax or Valium), or other sedating drugs. Providers will regularly assess for these side effects during visits per standard of care. Participants will receive buprenorphine/naloxone medication (sublingual) at no added cost to themselves, in addition to related provider services during visits. Currently buprenorphine/naloxone (sublingual tablet formulation) is offered free of cost through a subsidy program for uninsured patients in Durham County, and also carries no associated co-pay for insured patients with Medicaid or Medicare (participants with other forms of insurance may be charged a co-pay). Long-acting injectable formulations will not be offered for this pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| emPath Intervention | Experimental | Behavioral: emPath InterventionParticipants receive access to the emPath telemedicine platform and virtual MOUD care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 or older
- Screen positive for moderate to high risk opioid use by WHO-ASSIST
- Not currently prescribed any form of MOUD
- Able to speak and understand English
- Able and willing to provide informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| emPath InterventionCommunity-partnered telemedicine platform providing registration, video visits, messaging, and low-barrier MOUD access. | Behavioural | emPath Intervention |
Primary outcome
feasibility, as measured by retention in care
Time frame: up to 6 month visit
Retention in care is defined by at least one virtual visit conducted before and after the expected 3- or 6-month timepoint from enrollment, whichever later timepoint is available based on the participant's timing of enrollment during the study period.
5 secondary outcomes
acceptability
Time frame: 3-month follow-up assessment via the AIM survey, ≤ 5 minutes to complete 6-month follow-up assessment (if applicable) via the AIM survey, ≤ 5 minutes to complete
appropriateness
Time frame: 3-month IAM assessment ≤ 5 minutes 6-month IAM assessment (if applicable) ≤ 5 minutes
intervention fidelity
Time frame: Baseline survey ≤ 5 minutes 6-month survey ≤ 5 minutes
Intervention reach, as measured by weekly and monthly rates of participant platform feature engagement (dashboard, messaging, queue, video portal)
Time frame: From enrollment through the end of the study period, up to 12 months
Intervention adoption, as measured by weekly and monthly rates of staff platform feature engagement (dashboard, messaging, queue, video portal)
Time frame: From enrollment through the end of the study period, up to 12 months
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 9 Sep 2026.
- Provides information about the emPath web platform.Link provided by the sponsor.
- 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.
Amy Hobbie contact
Jacqueline Hodges, MD MPH principal investigator
Duke 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 emPath Intervention in people with Opioid Use Disorder and Digital Health Intervention, run by Duke 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 8 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 9 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?
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 Jacqueline Hodges, MD MPH (919 681 1309, jacqueline.hodges@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility, as measured by retention in care (time frame: up to 6 month visit). 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 9 Sep 2026.