An interventional study of Embodied conversational agent (ECA) and Technical support in Opioid Use Disorder, sponsored by Boston Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Supportive care
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).
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.
Exclusion Criteria:
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.
Other: Embodied conversational agent (ECA) · Other: Technical support · Other: Additional ECA messages · Other: Additional incentives
Participants randomized into this arm will receive treatment as usual
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
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.
Time frame: 12 months
Treatment retention at 6 months
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.
Time frame: 6 months
Treatment duration
Treatment duration is defined as length of continuous buprenorphine treatment in days until first discontinuation and will be measured via electronic health record (EHR) prescription and injection data and supplemented with self-report. Discontinued buprenorphine treatment occurs once the EHR indicates that they haven't filled a buprenorphine prescription or haven't received a buprenorphine injection in the previous 60 days. The treatment discontinuation date will be the last day of an active prescription or injection received.
Time frame: 6 months. 12 months
Opioid use
Opioid use will be measured by self-report via the modified Addiction Severity Index (ASI). The modified ASI is administered by the study staff for a list of 20 drugs/substances. For each the number of days of use and the route of administration of that drug/substance \[0=N/A, 1=oral, 2=nasal, 3=smoking, 4=non-intravenous (IV), injection 5=IV, or 8=refused\] is documented.
Time frame: 6 months
Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS)
The SU-SMS is a self reported, 18-item instrument. Each item has a 5 Likert frequency responses from 1=Never to 5=Very often. Total scores can range from 1 to 90 or from 1-30 for each of the three types of stigma \[anticipated, enacted, and internalized\]. Lower scores are correlated with less stigma.
Time frame: Baseline, 6 months
Changes in stigma based on the Buprenorphine Treatment Stigma Mechanism Scale (BT-SMS)
BT-SMS is a self reported, 25-item instrument. Each item has a 5 Likert frequency responses from 1=Never to 5=Very often. Total scores can range from 1 to 125 or from 1-45 for anticipated stigma, 1-45 for enacted stigma, and 1-35 for internalized stigma. Lower scores are correlated with less stigma.
Time frame: Baseline, 6 months
Changes in recovery capital
Changes in recovery capital will be measured by self-report via the Brief Assessment of Recovery Capital (BARC-10) which is a 10-item self administered instrument. Each item has 6 Likert possible responses where 1=Strongly disagree to 6=Strongly agree. Total scores can range from 1 to 60. Higher scores are correlated with more recovery capital.
Time frame: Baseline, 6 months
Frequency of interaction with the ECA app
Frequency of interactions with the ECA app will be collected via the app itself and provided to the BMC study team by the investigators at Northeastern University.
Time frame: 6 months, 12 months
User attitude and satisfaction toward the ECA
User attitudes and satisfaction with the ECA app will be measured by self-report using the Bond subscale of the Working Alliance Inventory which is an investigator developed instrument. The Bond subscale has 6 questions with an analog type response from 'disagree completely' to 'agree completely'.
Time frame: 6 months
Plan to share: Yes — All data produced in the course of the project will be preserved and shared upon reasonable request.
Supporting information: Study protocol, Sap, Icf
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