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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA058124-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Treatment as usual group | No Intervention | Participants randomized into this arm will receive treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embodied conversational agent (ECA) | Other | The app with the ECA will be provided. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Treatment duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karsten Lunze, MD MPH DrPH | Contact | 617 414 6933 | karsten.lunze@bmc.org | |
| Samantha Blakemore, MPH | Contact | 617-383-9226 | samantha.blakemore@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Karsten Lunze, MD MPH DrPH | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office-Based Addiction Treatment (OBAT) Clinic, BMC | Recruiting | Boston | Massachusetts | 02118 | United States |
All data produced in the course of the project will be preserved and shared upon reasonable request.
Shared data generated from this project will be made available as soon as possible, and no later than at the time of publication. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.
Data will be available by controlled access only. To access data users must submit an informal data request and signs BMC's Data Use Agreement (DUA), which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in any unauthorized uses of the data. To get access to the data, the user must submit a valid scientific question, include a statistical analysis plan. The MPIs will review the data request for scientific merit.
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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| Technical support | Other | 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. |
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| Additional ECA messages | Other | Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff. |
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| Additional incentives | Other | 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 |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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'. | 6 months |