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

NCT07140926 | Completed FDA Device

• 1 other identifier: 11629
• Study Type: interventional
• Target: 1,524
• Locations: 1 country
• Sites: 9

Brief 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

Opioid Use Disorder

Keywords

Digital Intervention; Opioid Use Disorder; Treatment Retention; Stepped-Wedge Cluster Randomized Trial; Digital Application; Medication-Assisted Treatment; Addictions

Outcome Measures

Primary Outcomes (1)

• Treatment retention

  Retention is defined according to federal guidelines, which allow patients to be readmitted within 30 days without restarting the intake process. A patient is considered not retained if a treatment gap of 30 consecutive days begins within the first 30 days after intake. The first day of that gap is recorded as the dropout date.

  From admission to 60 days post admission (in order to determine whether a 30 day gap began in the first 30 days and thus determine 30-day retention)

Secondary Outcomes (2)

• Treatment continuance

  From admission to 30 days post-admission

• 3, 7, and 30 day doses

  3, 7 and 30 days post admission

Study Arms (2)

Implementation of digital app at the clinic (Recovery Connect)

EXPERIMENTAL

Implementation consists of two components: Clinician training: Addiction treatment professionals complete live virtual training with step-by-step guides, video tutorials, and ongoing technical support. Training covers app features, patient linkage, and app-based communication strategies. Patient onboarding: Following training, clinicians introduce the app to newly admitted patients, assist with downloading and linking via QR code, and demonstrate core features such as daily check-ins, homework activities, and secure messaging.

Device: Recovery Connect

Usual Care

NO INTERVENTION

Clinics in the control condition continue providing standard medication-assisted treatment (MAT) for opioid use disorder (OUD) without the Recovery Connect app. Usual care includes in-person counseling sessions, medication management, and access to peer support and ancillary services, following each clinic's existing protocols and best practices. Patients do not receive access to the Recovery Connect platform during this phase, and clinicians do not use app-based tools or data to inform care.

Interventions

Recovery Connect DEVICE

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.

Implementation of digital app at the clinic (Recovery Connect)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All newly admitted patients to participating clinics

You may not qualify if:

• Dosing suggesting a transfer from a non-participating clinic, or if they had previously used the app prior to their most recent admission during the study period.

Sponsors & Collaborators

• Bright Therapeutics: lead
• Community Medical Services: collaborator

Study Sites (9)

Community Medical Services

Anchorage, Alaska, 99508, United States

Location

Community Medical Services

Wasilla, Alaska, 99654, United States

Location

Community Medical Services

Billings, Montana, 59102, United States

Location

Community Medical Services

Bozeman, Montana, 59714, United States

Location

Community Medical Services

Kalispell, Montana, 59901, United States

Location

Community Medical Services

Missoula, Montana, 59801, United States

Location

Community Medical Services

Fargo, North Dakota, 58103, United States

Location

Community Medical Services

Grand Forks, North Dakota, 58201, United States

Location

Community Medical Services

Minot, North Dakota, 58703, United States

Location

Related Publications (1)

• Palacios JE, Sherrick R, Janssen T, Deuble E, Lorenzen S, Schaefer M, Tregarthen J. Implementation of a Mobile Digital Tool Supporting Medication for Opioid Use Disorder Treatment Improves Retention: Stepped-Wedge Cluster Randomized Controlled Trial. J Med Internet Res. 2025 Dec 22;27:e83346. doi: 10.2196/83346.

  PMID: 41429011 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Jorge Palacios, MD, PhD

  Bright Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a stepped-wedge cluster randomized trial. Clusters of clinics will transition in a randomized sequence from a control period (usual care) to an intervention period (Recovery Connect). Each cluster serves as its own control, allowing comparisons within and across clinics. The stepped-wedge design was chosen to enable pragmatic, real-world implementation while maintaining the ability to assess causal effects. The staggered rollout also allows adjustment for temporal trends and clinic-level variability.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 26, 2025
• Study Start: January 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 31, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)