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Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents

NCT ID: NCT06732596

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-30

Study Completion Date

2026-12-31

Brief Summary

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This study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone-delivered recovery support intervention. The intervention involves an Embodied Conversational Agent (ECA), a virtual, animated computer agent designed to simulate natural face-to-face conversations. ECAs have been shown to help individuals manage their healthcare in other settings, and this study seeks to evaluate their potential in supporting patients on medication for opioid use disorder (MOUD).

Detailed Description

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One hundred participants will be enrolled in the study from the Office-Based Addiction Treatment (OBAT) clinic at Boston Medical Center (BMC). The participants will be randomly assigned to one of two groups. In the intervention group, participants will engage in ECA use and will receive (1) technical support, (2) text message reminders, and (3) monetary incentives. Alternatively, participants will be randomized to the treatment as usual group where they do not access the ECA application. Assessments will be conducted in person at baseline and over the phone at 6 months and 12 months. At 3 and 9 months, research staff will make brief telephone contacts to confirm or update participant contact information. The primary outcome is retention in buprenorphine treatment over 12 months.

Conditions

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Opioid Use Disorder

Keywords

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Embodied conversational agent (ECA) Buprenorphine treatment Medication for opioid use disorder (MOUD) Office Based Addiction Treatment Supportive Application for Recovery Assistance (SARA) Smartphone delivered intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of two groups: 50 will receive the ECA intervention (including technical support, text message reminders, and monetary incentives) in addition to usual care, while 50 will receive only usual care.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ECA, technical support, additional ECA messages, and incentives

Participants randomized into the intervention arm will be engaged in ECA use, technical support, additional ECA messages reminding the use of the ECA app on behalf of OBAT clinical staff, and monetary incentives.

Group Type EXPERIMENTAL

Embodied conversational agent (ECA)

Intervention Type OTHER

The app with the ECA will be provided.

Technical support

Intervention Type OTHER

Technical support will include assistance downloading and setting up the app on the participant's phone, walking them through a brief demonstration, and answering any questions the participant has about how to use the app.

Additional ECA messages

Intervention Type OTHER

Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff.

Additional incentives

Intervention Type OTHER

Additional incentives will be provided after logging into the app for 20 days followed by monthly lotteries for those who log in 15 days per month

Treatment as usual group

Participants randomized into this arm will receive treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Embodied conversational agent (ECA)

The app with the ECA will be provided.

Intervention Type OTHER

Technical support

Technical support will include assistance downloading and setting up the app on the participant's phone, walking them through a brief demonstration, and answering any questions the participant has about how to use the app.

Intervention Type OTHER

Additional ECA messages

Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff.

Intervention Type OTHER

Additional incentives

Additional incentives will be provided after logging into the app for 20 days followed by monthly lotteries for those who log in 15 days per month

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Opioid Use Disorder (OUD)
* Within 30 days of intake at recruitment site (BMC OBAT)
* Possession of a smartphone that has minimum requirements
* English-speaking and reading
* Willing to release electronic health record (EHR) data
* Able to provide at least two alternate contacts who usually know how to get in touch with them
* Currently prescribed buprenorphine from an outpatient clinic

Exclusion Criteria

* Incarceration anticipated within 12 months of enrollment
* Inability to comprehend the study protocol, defined as failing three times to answer correctly a set of questions during the consent process
* Inability to use the ECA app (i.e., due to markedly limited visual or auditory acuity or motor function required to interact with the ECA)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karsten Lunze, MD MPH DrPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Office-Based Addiction Treatment (OBAT) Clinic, BMC

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karsten Lunze, MD MPH DrPH

Role: CONTACT

Phone: 617 414 6933

Email: [email protected]

Samantha Blakemore, MPH

Role: CONTACT

Phone: 617-383-9226

Email: [email protected]

Facility Contacts

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Karsten Lunze, MD MPH DrPH

Role: primary

Samantha Blakemore, MPH

Role: backup

Other Identifiers

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1R34DA058124-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-45380

Identifier Type: -

Identifier Source: org_study_id