Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents (SARA RCT)

Boston Medical Center (BMC)

Status: Enrolling

Conditions: Opioid Use Disorder

Treatments: Other: Technical support; Other: Additional incentives; Other: Embodied conversational agent (ECA); Other: Additional ECA messages

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06732596

H-45380

1R34DA058124-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ECA, technical support, additional ECA messages, and incentives

Experimental group

Description:

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.

Treatment:

Other: Additional incentives

Other: Additional ECA messages

Other: Embodied conversational agent (ECA)

Other: Technical support

Treatment as usual group

No Intervention group

Description:

Participants randomized into this arm will receive treatment as usual