Office-Based Addiction Treatment (OBAT) Clinic, BMC
Boston, Massachusetts, 02118, United States
Location status: Recruiting
Location contact
Karsten Lunze, MD MPH DrPH
CONTACT
Samantha Blakemore, MPH
CONTACT
NCT Number: NCT06732596
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
Location status: Recruiting
Karsten Lunze, MD MPH DrPH
CONTACT
Samantha Blakemore, MPH
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The app with the ECA will be provided.
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.
Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff.
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Contact information is provided by the study sponsor or research team.
Karsten Lunze, MD MPH DrPH
CONTACT
Samantha Blakemore, MPH
CONTACT
Boston Medical Center
Other
Acronym: SARA RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05589181
Chemically-Induced Disorders, Mental Disorders
Newark, New Jersey, United States
View Trial DetailsNCT07064564
Chemically-Induced Disorders, Mental Disorders
Millcreek, Utah, United States
View Trial DetailsNCT06969261
Chemically-Induced Disorders, Mental Disorders
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT05511909
Anxiety, Anxiety Disorders
Baltimore, Maryland, United States
View Trial Details