Opioid Use DisorderSARA RCTNCT06732596
Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents
A study testing Embodied conversational agent (ECA), Technical support and Additional ECA messages in people with Opioid Use Disorder, run by Boston Medical Center at 1 site in United States.
Trial 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. 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?
- Embodied conversational agent (ECA), Technical support and Additional ECA messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Office-Based Addiction Treatment (OBAT) Clinic, BMC
Boston, Massachusetts, 02118
Karsten Lunze, MD MPH DrPH, 617-414-6933, karsten.lunze@bmc.org
Samantha Blakemore, MPH, 617-383-9226, samantha.blakemore@bmc.org
About this study
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).
Read the detailed description
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
- Opioid Use Disorder
- Being tested
- Embodied conversational agent (ECA), Technical support, Additional ECA messages, Additional incentives
- Keywords
- 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
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embodied conversational agent (ECA)Other
The app with the ECA will be provided.
Technical supportOther
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 messagesOther
Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff.
Additional incentivesOther
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
| Study group | Role | What they receive |
|---|---|---|
| ECA, technical support, additional ECA messages, and incentives | Experimental | 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. Receives: Other: Embodied conversational agent (ECA); Other: Technical support; Other: Additional ECA messages; Other: Additional incentives |
| Treatment as usual group | No intervention | Participants randomized into this arm will receive treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start30 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Karsten Lunze, MD MPH DrPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732596
- Sponsor's protocol ID
- H-45380
- Other IDs
- 1R34DA058124-01A1
- Acronym
- SARA RCT
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data produced in the course of the project will be preserved and shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents
- ClinicalTrials.gov ID
- NCT06732596
- Acronym / sponsor ID
- SARA RCT / H-45380
- Conditions
- Opioid Use Disorder
- Keywords
- 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 type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Dec 2024 (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.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ECA, technical support, additional ECA messages, and incentives | Experimental | Other: Embodied conversational agent (ECA), Other: Technical support, Other: Additional ECA messages, Other: Additional incentivesParticipants 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 intervention | –Participants randomized into this arm will receive treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Embodied conversational agent (ECA)The app with the ECA will be provided. | Other | ECA, technical support, additional ECA messages, and incentives |
| Technical supportTechnical 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. | Other | ECA, technical support, additional ECA messages, and incentives |
| Additional ECA messagesWeekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff. | Other | ECA, technical support, additional ECA messages, and incentives |
| Additional incentivesAdditional 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 | Other | ECA, technical support, additional ECA messages, and incentives |
Primary outcome
Number of participants that stay engaged in buprenorphine treatment
Time frame: 12 months
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.
8 secondary outcomes
Treatment retention at 6 months
Time frame: 6 months
Treatment duration
Time frame: 6 months. 12 months
Opioid use
Time frame: 6 months
Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS)
Time frame: Baseline, 6 months
Changes in stigma based on the Buprenorphine Treatment Stigma Mechanism Scale (BT-SMS)
Time frame: Baseline, 6 months
Changes in recovery capital
Time frame: Baseline, 6 months
Frequency of interaction with the ECA app
Time frame: 6 months, 12 months
User attitude and satisfaction toward the ECA
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. All data produced in the course of the project will be preserved and shared upon 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.
Karsten Lunze, MD MPH DrPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embodied conversational agent (ECA), Technical support and Additional ECA messages in people with Opioid Use Disorder, run by Boston Medical Center at 1 site 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karsten Lunze, MD MPH DrPH (617 414 6933, karsten.lunze@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that stay engaged in buprenorphine treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.