A Brief Negotiation Interview Chatbot to Improve Buprenorphine Engagement Among Justice-Involved … (NCT04982627) | Clinical Trial Compass
CompletedNot Applicable
A Brief Negotiation Interview Chatbot to Improve Buprenorphine Engagement Among Justice-Involved Individuals
United States4 participantsStarted 2021-08-01
Plain-language summary
Primary Objective:
Conduct pilot study to assess effects of brief negotiation interview (BNI) Chatbot among individuals involved in the Connecticut criminal justice system with opioid use disorder (OUD).
Study Duration:
Approximately 2 years (1 year for study activities, 1 year for data analysis)
Study Design:
This is a prospective, randomized study to evaluate the effectiveness of a BNI Chatbot on patients with OUD compared with Standard Care (SC).
Number of Study Sites:
The offices of the Center for Progressive Recovery, LLC and the New Haven Police Department Detention Center (NHPD).
Study Population:
The study population includes adult individuals with OUD who are involved in the Connecticut criminal justice system and not currently receiving medication-assisted treatment for their OUD.
Number of Participants:
Sixty participants
Primary Outcome Variable:
Attendance at participants first treatment appointment within four weeks of referral among participants in the BNI Chatbot vs. Standard Care (SC) groups.
Secondary Outcome and Exploratory Outcome Variables:
Secondary outcomes include readiness and intention to engage in buprenorphine (bup) treatment, and urine toxicology test-confirmed drug use at four weeks among participants in BNI Chatbot vs. SC groups. Exploratory outcomes include ratings of feasibility, acceptability and satisfaction between study groups, and a comparison of study findings to engagement data from previous in-person studies, including BNI+bup, and other digital programs, such as reSET-O, and DynamiCare.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Can speak, read and write in English
. Provision of signed and dated informed consent form
. Adult aged \>18 years
. Screened positive for opioid use disorder (OUD), moderate or severe, based on the Diagnostic and Statistical Manual-5th Edition
. Have health insurance
. Have an existing electronic medical record in Epic
. Have a working device that can access a web browser and receive texts (i.e., smartphone, tablet or computer)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.