Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder

• Registration Number: NCT06732596
• Lead Sponsor: Boston Medical Center

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).

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: 75 will receive the ECA intervention in addition to usual care, while 25 will receive treatment as usual. The ECA group will be further divided into three subgroups based on different engagement strategies: 1) technical support only, 2) technical support with additional messages from the ECA on behalf of OBAT clinic staff, and 3) the same as group 2, but with incentives if they log into the app for 15 days that month. The primary outcome is retention in buprenorphine treatment over 12 months.

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Study Start: 2025-05
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of Opioid Use Disorder (OUD)
• Within 14 days of intake at recruitment site (BMC OBAT) and 30 days of current buprenorphine treatment episode
• Possession of a smartphone that has minimum requirements
• English-speaking
• 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
• Able to provide informed consent and participate in this study

Exclusion Criteria

• Treatment with sublingual buprenorphine in the 30 days prior to current treatment episode (56 days for long acting injectable buprenorphine), excluding bridge prescriptions of less than three days
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants that stay engaged in buprenorphine treatment	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.

Secondary Outcome Measures

Name	Time	Method
Treatment retention at 6 months	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.
Treatment duration	6 months. 12 months	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.
Opioid use	6 months	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.
Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS)	Baseline, 6 months	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.
Changes in stigma based on the Buprenorphine Treatment Stigma Mechanism Scale (BT-SMS)	Baseline, 6 months	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.
Changes in recovery capital	Baseline, 6 months	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.
Frequency of interaction with the ECA app	6 months, 12 months	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.
User attitude and satisfaction toward the ECA	6 months	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'.

Trial Locations

Locations (1)

Office-Based Addiction Treatment (OBAT) Clinic, BMC; 🇺🇸 Boston, Massachusetts, United States