Recruiting

Buprenorphine

Sponsor:

Boston Medical Center

Code:

NCT06732596

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Embodied conversational agent (ECA)

Technical support

Additional ECA messages

Additional incentives

Study Details

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).

Conditions

Opioid Use Disorder

Study ID

NCT06732596

Start date

Oct 30, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Treatment as usual group

Participants randomized into this arm will receive treatment as usual

Interventions

Embodied conversational agent (ECA)

The app with the ECA will be provided.

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.

Additional ECA messages

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

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

Primary outcome measure

  • Number of participants that stay engaged in buprenorphine treatment [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Karsten Lunze, MD MPH DrPH

617 414 6933karsten.lunze@bmc.org

Samantha Blakemore, MPH

617-383-9226samantha.blakemore@bmc.org

Locations

Office-Based Addiction Treatment (OBAT) Clinic, BMC

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Karsten Lunze, MD MPH DrPH

617-414-6933karsten.lunze@bmc.org

Samantha Blakemore, MPH

617-383-9226samantha.blakemore@bmc.org

More Information

Sponsor

Boston Medical Center

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2025-11-03.