A Brief Negotiation Interview Chatbot to Improve Buprenorphine Engagement Among Justice-Involved Individuals

NCT04982627 | Completed DMC

• 2 other identifiers: 2000030168R43DA051267
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder, Moderate; Opioid Use Disorder, Severe; Criminal Behavior

Keywords

Chatbot; Conversational Agent; Artificial Intelligence; Natural Language Processing; Machine Learning; Medication-Assisted Treatment; Buprenorphine; Treatment Engagement; Criminal Justice; Brief Intervention; Brief Negotiation Interview

Outcome Measures

Primary Outcomes (1)

• Treatment Engagement

  Attendance at addiction treatment appointments

  1-month post-randomization

Secondary Outcomes (2)

• Drug Use

  1-month post randomization

• Intervention FAS

  Immediately Post-Intervention

Study Arms (2)

Brief Negotiation Interview Chatbot (BNI Chatbot)

EXPERIMENTAL

Participants will receive a link to register for the chatbot. Following registration, they will complete the initial chat, which includes instructions for the entire study. The chatbot will then guide the participant through multiple BNIs focused on the goal of bup engagement, with the following steps: 1) Raise the Subject/Establish Rapport; 2) Enhance Motivation; 3) Provide \& Elicit Feedback; and 4) Negotiate a Plan. The chatbot then reminds the participant of their reasons why they might engage in OUD treatment based on their responses to Steps 2 \& 3, and their negotiated plan. The chatbot will electronically connect participants to a treatment provider of their choice, based on available options.

Behavioral: BNI Chatbot

Standard Care (OUD Education & Referral Resources)

ACTIVE COMPARATOR

• SC: The RA will provide participants with an electronic link, which provides OUD and bup education, and lists OUD treatment options and descriptions and locations, including bup prescribers. After reviewing, participants will be asked to choose from among the list of and a referral will be made based on the receiving treatment providers' procedures. These participants will not have access to the BNI chatbot. However, the referral facilitation, the electronic link will direct participants to a short Feasibility, Acceptability and Satisfaction (FAS) Assessment to obtain feedback on the process.

Behavioral: OUD Education & Treatment Resources

Interventions

BNI Chatbot BEHAVIORAL

The BNI Chatbot is a web application that guides participants through a brief motivational intervention that motivates them to engage in treatment for opioid use disorder.

Brief Negotiation Interview Chatbot (BNI Chatbot)

OUD Education & Treatment Resources BEHAVIORAL

The OUD Education \& Treatment Resources intervention is a web application that provides OUD education and treatment resources.

Also known as: Standard Care

Standard Care (OUD Education & Referral Resources)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Can provide a working email address
• Can provide a working cell phone number

You may not qualify if:

• Current use of buprenorphine (bup), methadone, or naltrexone for a substance use disorder
• Known allergy to bup
• Pregnancy or lactation
• Known current suicide risk based on interview
• Mandatory transport to a Department of Correction Facility, or strong likelihood of immediate transport, resulting from current legal case

Sponsors & Collaborators

• Center for Progressive Recovery, LLC: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Yale University: collaborator

Study Sites (1)

Center for Progressive Recovery

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Lymphoma, Follicular; Criminal Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael V Pantalon, PhD

  Center for Progressive Recovery, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 29, 2021
• Study Start: August 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: September 1, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)