NCT07810322

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jul 2026Mar 2027

Study Start

First participant enrolled

July 29, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

September 9, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 12, 2026

Last Update Submit

September 3, 2026

Conditions

Opioid Use DisorderDigital Health InterventionTelemedicineOutreach Intervention

Keywords

Opioid Use DisorderTelemedicineMedication for Opioid Use Disordermobile health appSuboxone

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 6 month visit

Secondary Outcomes (5)

  • acceptability

    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

    3-month IAM assessment ≤ 5 minutes 6-month IAM assessment (if applicable) ≤ 5 minutes

  • intervention fidelity

    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)

    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)

    From enrollment through the end of the study period, up to 12 months

Study Arms (1)

emPath Intervention

EXPERIMENTAL

Participants receive access to the emPath telemedicine platform and virtual MOUD care.

Behavioral: emPath Intervention

Interventions

emPath InterventionBEHAVIORAL

Community-partnered telemedicine platform providing registration, video visits, messaging, and low-barrier MOUD access.

emPath Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Project MAPS (Mobile Addiction Treatment and Primary Care Services)

Durham, North Carolina, 27703, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jacqueline Hodges, MD MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Hodges, MD MPH

CONTACT

919 681 1309jacqueline.hodges@duke.edu

Amy Hobbie

CONTACT

amy.hobbie@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2026

First Posted

September 9, 2026

Study Start

July 29, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

September 9, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)