MedTrace Logo

A Stepped-Wedge Cluster Randomized Trial of a Digital App to Support Medication-Assisted Treatment in Individuals With Opioid Use Disorder

NCT07140926 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1524

Last updated 2025-08-26

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a mobile health app called Recovery Connect can help people stay in treatment for opioid use disorder. The study is being done with adults receiving medication-assisted treatment in outpatient opioid treatment programs.

The main questions it aims to answer are:

Does Recovery Connect increase the number of people who remain in treatment after 30 days?

Does Recovery Connect improve continuity of care during the first month of treatment?

Researchers are using a stepped-wedge design, which means that all participating clinics will eventually use the app, but they will begin at different time points in a randomized order. This allows researchers to compare outcomes before and after each clinic starts using Recovery Connect.

Participants will:

Use the Recovery Connect app for daily check-ins, coping strategies, and reminders to support their recovery

Share progress and risk information through the app so counselors can provide timely, personalized support

Work with treatment teams trained to use the app to guide care and reinforce accountability

Conditions

Interventions

DEVICE

Recovery Connect

Recovery Connect is a white-labeled version of the Recovery Path platform, rebranded to maintain partner organizations' brand identity while leveraging its established digital infrastructure. Recovery Path is a HIPAA-compliant remote patient monitoring system that supports a blended model of care for medication for opioid use disorder (MOUD), integrating in-person treatment with continuous digital engagement. The app provides patients with daily check-ins, access to evidence-based resources and coping strategies, and secure messaging with their care teams. Clinicians receive real-time data on patient progress, risks, and setbacks. Between visits, clinicians can recommend tailored coping tools and psychoeducational content, reinforcing accountability and enhancing continuity of care. RC is also integrated into the clinic's electronic medical record system to streamline workflows, reduce administrative burden, and improve documentation accuracy through auto-generated case notes.

Sponsors & Collaborators

  • Community Medical Services

    collaborator UNKNOWN

  • Bright Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jorge Palacios, MD, PhD · Bright Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-11-01
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07140926 on ClinicalTrials.gov