Opiate-Related DisordersPhase 1/2NCT06845878
A Chatbot To Support Substance Use Recovery
A Phase 1/2 study testing chatbot in people with Opiate-Related Disorders and Opiate Substitution Treatment, run by Dimagi Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opiate-Related Disorders, Opiate Substitution Treatment
- What is being tested?
- chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2025to 22 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 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?
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Conversational Agent To Support Follow-up Care For Individuals In Recovery For Substance Use Disorder
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?
Read more
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
- Being tested
- chatbot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chatbotOther
Also called Suzy, conversational agent
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SUD severity
Addiction Severity Index (ASI) Drugs composite score; Scored 0-7 with higher scores indicating increasing severity
Measured: 12 weeks
Change in psychological health (Anxiety)
General Anxiety Disorder-7 (GAD-7); scored 0-21 with higher scores indicating increasing anxiety
Measured: 12 weeks
Change in psychological health (Depression)
Patient Health Questionnaire-8 (PHQ-8); scored 0-24 with higher scores indicating more severe depression
Measured: 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
Measured: 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
Measured: 12 weeks
Secondary outcomes (4)
Change in quality of life
World Health Organization Quality of Life (WHOQoL-BREF) Assessment; higher scores indicate higher quality of life
Measured: 12 weeks
Change in social needs
Accountable Health Communities Health-Related Social Needs (AHC HRSN) screening; higher scores indicate higher unmet social needs
Measured: 12 weeks
Chatbot usability
Chatbot Usability Questionnaire (CUQ); scored 0-100 with higher scores indicating higher usability
Measured: End of 12 week intervention
User Satisfaction
Net Promoter Score (NPS); scored -100 to 100 with higher scores indicating higher user satisfaction
Measured: End of 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start7 Mar 2025
- Primary completion1 Jun 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-Post Intervention
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dimagi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, Los Angeles, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Y. Xian Ho, PhD, Principal investigator, Dimagi Inc.Jonathan Jackson, MEng, Principal investigator, Dimagi Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845878
- Sponsor's protocol ID
- 2R44DA050218
- Other IDs
- 2R44DA050218-02
- Status last verified
- Jul 2026
- First submitted
- 18 Feb 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will include sensitive data from a small sample of patients with experience with substance use therefore data will be reported in aggregate and only qualitative data collected from participants may be reported individually and anonymously.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Conversational Agent To Support Follow-up Care For Individuals In Recovery For Substance Use Disorder
- ClinicalTrials.gov ID
- NCT06845878
- Acronym / sponsor ID
- 2R44DA050218
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Dimagi Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, Los Angeles, Massachusetts General Hospital
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-Post Intervention
| Arm | Type | Receives |
|---|---|---|
| Chatbot | Experimental | Other: chatbotParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chatbotAlso: Suzy, conversational agentParticipants 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. | Other | Chatbot |
Primary outcome
Change in SUD severity
Time frame: 12 weeks
Addiction Severity Index (ASI) Drugs composite score; Scored 0-7 with higher scores indicating increasing severity
Change in psychological health (Anxiety)
Time frame: 12 weeks
General Anxiety Disorder-7 (GAD-7); scored 0-21 with higher scores indicating increasing anxiety
Change in psychological health (Depression)
Time frame: 12 weeks
Patient Health Questionnaire-8 (PHQ-8); scored 0-24 with higher scores indicating more severe depression
Change in self-efficacy for managing chronic conditions (Emotions)
Time frame: 12 weeks
PROMIS Short Form 8a (Managing Emotions); scored from 8-40 with higher scores indicating higher confidence managing emotions
Change in self-efficacy for managing chronic conditions (Social Interactions)
Time frame: 12 weeks
PROMIS Short Form 8a (Social Interactions); scored from 8-40 with higher scores indicating higher confidence with managing social interactions
4 secondary outcomes
Change in quality of life
Time frame: 12 weeks
Change in social needs
Time frame: 12 weeks
Chatbot usability
Time frame: End of 12 week intervention
User Satisfaction
Time frame: End of 12 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. This study will include sensitive data from a small sample of patients with experience with substance use therefore data will be reported in aggregate and only qualitative data collected from participants may be reported individually and anonymously.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Y. Xian Ho, PhD principal investigator
Dimagi Inc.
Jonathan Jackson, MEng principal investigator
Dimagi Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing chatbot in people with Opiate-Related Disorders and Opiate Substitution Treatment, run by Dimagi Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SUD severity (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.