Opioid Use Disorder
Conditions
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
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. 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.
Interventions
The app with the ECA will be provided.
OTHERTechnical 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.
OTHERAdditional ECA messages
Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff.
OTHERAdditional 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
Sponsors
National Institute on Drug Abuse (NIDA)
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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'. |
| 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. |
Countries
United States
Contacts
Primary ContactKarsten Lunze, MD MPH DrPH
Backup ContactSamantha Blakemore, MPH
Outcome results
None listed