A Chatbot To Support Substance Use Recovery

NCT06845878 | Active Not Recruiting Phase 1

• 2 other identifiers: 2R44DA0502182R44DA050218-02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if/how an AI chatbot can support patients who in recovery for substance use, specifically those who are receiving medication for opioid use disorder. Can the chatbot help lower drug use? Can the chatbot help improve clinical appointment adherence? Can the chatbot help patients build self-efficacy in leading their own recovery journey? Will the chatbot help reduce workload burden for primary care teams? Can the chatbot serve as a safe, useful and engaging tool to support patients? Researchers will investigate the effects of using a chatbot to support follow-up care for patients in opioid use recovery. Participants will:

• Receive access to a chatbot for 12 weeks that they can use to prepare for upcoming clinical appointments, find community resources, learn about urge-surfing and wellness techniques, and query for assistance with other recovery-related information and tasks
• Complete surveys and provide user feedback

Conditions

Opiate-Related Disorders; Opiate Substitution Treatment

Outcome Measures

Primary Outcomes (5)

• Change in SUD severity

  Addiction Severity Index (ASI) Drugs composite score; Scored 0-7 with higher scores indicating increasing severity

  12 weeks

• Change in psychological health (Anxiety)

  General Anxiety Disorder-7 (GAD-7); scored 0-21 with higher scores indicating increasing anxiety

  12 weeks

• Change in psychological health (Depression)

  Patient Health Questionnaire-8 (PHQ-8); scored 0-24 with higher scores indicating more severe depression

  12 weeks

• Change in self-efficacy for managing chronic conditions (Emotions)

  PROMIS Short Form 8a (Managing Emotions); scored from 8-40 with higher scores indicating higher confidence managing emotions

  12 weeks

• Change in self-efficacy for managing chronic conditions (Social Interactions)

  PROMIS Short Form 8a (Social Interactions); scored from 8-40 with higher scores indicating higher confidence with managing social interactions

  12 weeks

Secondary Outcomes (4)

• Change in quality of life

  12 weeks

• Change in social needs

  12 weeks

• Chatbot usability

  End of 12 week intervention

• User Satisfaction

  End of 12 week intervention

Study Arms (1)

Chatbot

EXPERIMENTAL

Participants will receive access to a chatbot for 12 weeks that can be used from a mobile device to support follow-up care and recovery needs.

Other: chatbot

Interventions

chatbot OTHER

Participants will: * Participate in a baseline session to complete an initial survey and get trained on using the chatbot * Use the chatbot for 12 weeks and submit a brief weekly survey to provide feedback * Complete a final survey to provide substance use and health information as well as give feedback on the experience using the chatbot * Allow access to a limited set of demographic, substance use and health information in electronic health record for study analyses and context.

Also known as: Suzy, conversational agent

Chatbot

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Comfortable with reading, understanding, and communicating in English
• Receiving medication treatment for OUD at MGH?
• Able to participate in a remote interview?
• Own or have reliable access to Wi-Fi or a cellular network
• Willing to use a mobile device to access the chatbot?

You may not qualify if:

• Has any cognitive, visual, or auditory impairments that may prevent the participant from using the chatbot on a mobile device?
• Unstable medical condition that compromises the ability to safely participate

Sponsors & Collaborators

• Dimagi Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of California, Los Angeles: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Y. Xian Ho, PhD

  Dimagi Inc.

  PRINCIPAL INVESTIGATOR

• Jonathan Jackson, MEng

  Dimagi Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pre-Post Intervention

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 25, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)