Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents
SARA RCT
2 other identifiers
interventional
100
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2024
CompletedFirst Posted
Study publicly available on registry
December 13, 2024
CompletedStudy Start
First participant enrolled
October 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 3, 2025
October 1, 2025
1.1 years
December 10, 2024
October 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants that stay engaged in buprenorphine treatment
Engaged in buprenorphine treatment or treatment retention is defined as a participant's treatment period of at least 365 days, including those with multiple disengagement and reengagement periods, as long as any gap in active prescriptions or receipt of injections is less than 60 days.
12 months
Secondary Outcomes (8)
Treatment retention at 6 months
6 months
Treatment duration
6 months. 12 months
Opioid use
6 months
Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS)
Baseline, 6 months
Changes in stigma based on the Buprenorphine Treatment Stigma Mechanism Scale (BT-SMS)
Baseline, 6 months
- +3 more secondary outcomes
Study Arms (2)
ECA, technical support, additional ECA messages, and incentives
EXPERIMENTALParticipants 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.
Treatment as usual group
NO INTERVENTIONParticipants randomized into this arm will receive treatment as usual
Interventions
The app with the ECA will be provided.
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.
Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Medical Centerlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Office-Based Addiction Treatment (OBAT) Clinic, BMC
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karsten Lunze, MD MPH DrPH
Boston Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2024
First Posted
December 13, 2024
Study Start
October 30, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 3, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Shared data generated from this project will be made available as soon as possible, and no later than at the time of publication. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.
- Access Criteria
- Data will be available by controlled access only. To access data users must submit an informal data request and signs BMC's Data Use Agreement (DUA), which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in any unauthorized uses of the data. To get access to the data, the user must submit a valid scientific question, include a statistical analysis plan. The MPIs will review the data request for scientific merit.
All data produced in the course of the project will be preserved and shared upon reasonable request.