Opioid Use DisorderSMART-OUDNCT07140926
A Stepped-Wedge Cluster Randomized Trial of a Digital App to Support Medication-Assisted Treatment in Individuals With Opioid Use Disorder
A study testing Recovery Connect in people with Opioid Use Disorder, run by Bright Therapeutics at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Recovery Connect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,524 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All newly admitted patients to participating clinics
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Community Medical Services
Anchorage, Alaska, 99508
Community Medical Services
Billings, Montana, 59102
Community Medical Services
Bozeman, Montana, 59714
Community Medical Services
Fargo, North Dakota, 58103
Community Medical Services
Grand Forks, North Dakota, 58201
Community Medical Services
Kalispell, Montana, 59901
Community Medical Services
Minot, North Dakota, 58703
Community Medical Services
Missoula, Montana, 59801
Community Medical Services
Wasilla, Alaska, 99654
About this study
Official title: Digital Innovation in Medication-Assisted Treatment for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Trial
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:
Read more
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
Read the detailed description
This study is a stepped-wedge cluster randomized clinical trial evaluating the implementation and effectiveness of Recovery Connect, a mobile health application designed to support individuals receiving medication-assisted treatment (MAT) for opioid use disorder (OUD). Recovery Connect is intended to enhance treatment delivery by:
Providing clinicians with real-time, self-monitored patient progress data to support measurement-based and data-informed care.
Delivering personalized care plans, reminders, and evidence-based coping strategies directly to patients.
Facilitating continuous communication and accountability between patients and counselors between sessions.
Study Design
The trial is conducted across nine outpatient opioid treatment program (OTP) clinics, grouped into eight clusters. Using a stepped-wedge design, each cluster will transition from usual care to the Recovery Connect intervention at randomized, sequential time points, such that all clinics will eventually receive the intervention. All clinicians at each cluster will receive standardized training on Recovery Connect at rollout, with follow-up reinforcement training provided two weeks later. Auxiliary staff (e.g., front desk, peer support, navigators) will also be trained to support patient onboarding.
Participants All clinicians at participating clinics will be included. Patient-level data will be analyzed for all new admissions and readmissions during the study period.
Data Collection
App Usage and Engagement: Patient and clinician usage data, including daily check-ins, logins, and secure messages, will be captured directly through the app.
Patient Treatment Outcomes: Treatment retention and continuity data will be obtained via the Methasoft medical record system, following standard clinic protocols.
Operational Definitions
Exposure: Patients are considered "exposed" if their admission occurred after clinicians at their clinic had completed Recovery Connect training.
Linkage: Patients are considered "linked" if they downloaded the app and were connected with a trained clinician during admission.
Engagement: Defined by app activity within the first week after linkage, including logins, daily check-ins, and secure messaging.
Analyses The primary analyses will use an intent-to-treat framework, including all eligible patients whose clinic underwent Recovery Connect training. Outcomes will be assessed using multilevel logistic regression and cluster-controlled discrete-time survival analyses, accounting for the stepped-wedge design.
- Conditions
- Opioid Use Disorder
- Being tested
- Recovery Connect
- Keywords
- Digital Intervention, Opioid Use Disorder, Treatment Retention, Stepped-Wedge Cluster Randomized Trial, Digital Application, Medication-Assisted Treatment, Addictions
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery ConnectDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Defined as have received at least three quarters (75%) of expected daily doses within the first 30 days following admission, and at least one dose administered during the final week of that period.
Measured: From admission to 30 days post-admission
3, 7, and 30 day doses
Number of daily medications for opioid use disorder administered successfully and confirmed, during the first 3, 7 and 30 days post admission.
Measured: 3, 7 and 30 days post admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Jan 2024
- Primary completion1 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Community Medical Services
- Responsible party
- Sponsor
- Investigators
- Jorge Palacios, MD, PhD, Principal investigator, Bright Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140926
- Sponsor's protocol ID
- 11629
- Acronym
- SMART-OUD
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The datasets generated and analyzed during this study will not be publicly available due to data confidentiality agreements in place between Bright Therapeutics and Community Medical Services, but select de-identified data will be made available from the corresponding author on reasonable request.
Publications
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.
PubMed 41429011
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Innovation in Medication-Assisted Treatment for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT07140926
- Acronym / sponsor ID
- SMART-OUD / 11629
- Conditions
- Opioid Use Disorder
- Keywords
- Digital Intervention, Opioid Use Disorder, Treatment Retention, Stepped-Wedge Cluster Randomized Trial, Digital Application, Medication-Assisted Treatment, Addictions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,524 participants (actual)
- Lead sponsor
- Bright TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Community Medical Services
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Aug 2025 (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.
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
Detailed description
This study is a stepped-wedge cluster randomized clinical trial evaluating the implementation and effectiveness of Recovery Connect, a mobile health application designed to support individuals receiving medication-assisted treatment (MAT) for opioid use disorder (OUD). Recovery Connect is intended to enhance treatment delivery by:
Providing clinicians with real-time, self-monitored patient progress data to support measurement-based and data-informed care.
Delivering personalized care plans, reminders, and evidence-based coping strategies directly to patients.
Facilitating continuous communication and accountability between patients and counselors between sessions.
Study Design
The trial is conducted across nine outpatient opioid treatment program (OTP) clinics, grouped into eight clusters. Using a stepped-wedge design, each cluster will transition from usual care to the Recovery Connect intervention at randomized, sequential time points, such that all clinics will eventually receive the intervention. All clinicians at each cluster will receive standardized training on Recovery Connect at rollout, with follow-up reinforcement training provided two weeks later. Auxiliary staff (e.g., front desk, peer support, navigators) will also be trained to support patient onboarding.
Participants All clinicians at participating clinics will be included. Patient-level data will be analyzed for all new admissions and readmissions during the study period.
Data Collection
App Usage and Engagement: Patient and clinician usage data, including daily check-ins, logins, and secure messages, will be captured directly through the app.
Patient Treatment Outcomes: Treatment retention and continuity data will be obtained via the Methasoft medical record system, following standard clinic protocols.
Operational Definitions
Exposure: Patients are considered "exposed" if their admission occurred after clinicians at their clinic had completed Recovery Connect training.
Linkage: Patients are considered "linked" if they downloaded the app and were connected with a trained clinician during admission.
Engagement: Defined by app activity within the first week after linkage, including logins, daily check-ins, and secure messaging.
Analyses The primary analyses will use an intent-to-treat framework, including all eligible patients whose clinic underwent Recovery Connect training. Outcomes will be assessed using multilevel logistic regression and cluster-controlled discrete-time survival analyses, accounting for the stepped-wedge design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Implementation of digital app at the clinic (Recovery Connect) | Experimental | Device: Recovery ConnectImplementation 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All newly admitted patients to participating clinics
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Recovery ConnectRecovery 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. | Device | Implementation of digital app at the clinic (Recovery Connect) |
Primary outcome
Treatment retention
Time frame: 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)
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.
2 secondary outcomes
Treatment continuance
Time frame: From admission to 30 days post-admission
3, 7, and 30 day doses
Time frame: 3, 7 and 30 days post admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Derived from this study: PubMed 41429011Palacios 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.
- Individual participant dataSharing planned: No. The datasets generated and analyzed during this study will not be publicly available due to data confidentiality agreements in place between Bright Therapeutics and Community Medical Services, but select de-identified data will be made available from the corresponding author on reasonable request.
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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. This study is not recruiting at the moment.
Jorge Palacios, MD, PhD principal investigator
Bright Therapeutics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Connect in people with Opioid Use Disorder, run by Bright Therapeutics at 9 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment retention (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07140926, which also lists 1 linked publication.
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 26 Aug 2025.