Alcohol MisuseMICA-EDNCT07661563
Advancing Scalable Alcohol Brief Interventions in the ED: A Trial of Conversational AI With Digital Reinforcements
A study testing MICA and TRAC in people with Alcohol Misuse, run by Stanford University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a novel digital strategy combining a generative AI counseling agent (MICA) and weekly SMS boosters works to reduce risky drinking among Emergency Department patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Misuse
- What is being tested?
- MICA and TRAC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2026to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- For men: AUDIT-C score 4+
- For women: AUDIT-C score 3+
- Owns a mobile phone
- Reads English language
Who cannot join
- For women: current or planned pregnancy in next 12 months
- Prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University Medical Center
Palo Alto, California, 94304
Brian Suffoletto, MD, 412-901-6892, suffbp@stanford.edu
About this study
Official title: A Randomized Trial of an AI Intervention to Help Individuals With Risky Alcohol Use Among Emergency Department Patients
The goal of this clinical trial is to learn if a novel digital strategy combining a generative AI counseling agent (MICA) and weekly SMS boosters works to reduce risky drinking among Emergency Department patients.
- Conditions
- Alcohol Misuse
- Being tested
- MICA, TRAC
- Keywords
- alcohol, emergency department, adults, AI, motivational interviewing, text messaging
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICABehavioural
MICA is an AI chatbot that uses a secure API with ChatGPT and prompted to follow MI principles to support individuals in exploring and resolving ambivalence about their alcohol use. MICA follows a predefined conversational framework and steps: introduction, engagement, focusing, evoking, planning, and closing-adapted from Miller \& Rollnick's Motivational Interviewing: Helping People Change (3rd ed.).
TRACBehavioural
Weekly SMS check-ins designed to support goal-setting, self-monitoring, and adaptive self-regulation strategies. Beginning the Sunday after enrollment, participants will engage with an automated SMS program once weekly for 12 weeks. Prompts include reporting on the past week's alcohol use and whether they are willing to commit to a drinking limit goal for the upcoming week. Responses trigger tailored feedback.
| Study group | Role | What they receive |
|---|---|---|
| MICA | Experimental | MICA is a generative AI-powered counseling agent that delivers brief Motivational Interviewing (MI)-consistent sessions, following the validated MI process (engagement, focusing, evoking, planning, and closing). It uses personalized prompts to promote autonomy and evoke change talk, ending with a session summary and satisfaction check. Participants will complete a MICA session (~5-10 min) in the ED and at 3 months. Receives: Behavioral: MICA |
| MICA+SMS | Experimental | This condition includes the MICA ED session, a 3-month booster, and 12 weeks of weekly SMS messages supporting self-monitoring, goal-setting, and adaptive strategies. Messages are tailored based on reported alcohol use and goal commitment, offering encouragement, feedback, and harm-reduction messaging. Receives: Behavioral: MICA; Behavioral: TRAC |
| Standard care | No intervention | Standard ED care and as-needed referral to alcohol resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean weekly alcohol consumption
Participants report (1) the average number of standard alcohol drinks each day of the week. Estimated weekly alcohol consumption will be calculated as the sum of all those drinks over 7 days.
Measured: Baseline, 3-, 6-, and 12-month follow-ups
Secondary outcomes (3)
Number of heavy drinking days
Asking participants: "Over the past 30 days, how many days did you have 4+ standard drinks (women) / 5+ standard drinks (men)?"
Measured: Baseline, 3-, 6-, and 12-month follow-ups
Max number of drinks per drinking day
Asking participants, "Over the past 30 days, what is the most drinks you had on any single day?"
Measured: Baseline, 3-, 6-, and 12-month follow-ups
AUDIT score
Alcohol Use Disorders Identification Test (AUDIT) is a 10 question screen for AUD (0-40 Scale; higher numbers indicate higher risk for AUD).
Measured: Baseline, 3-, 6, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start8 Oct 2026
- Primary completionAug 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Brian Suffoletto, Stanford University
- Investigators
- Brian Suffoletto, MS MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661563
- Sponsor's protocol ID
- 86953
- Acronym
- MICA-ED
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All survey data from baseline through 12-month followups will be uploaded to the data repository (the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA). All counseling sessions and SMS data will be de-identified and kept in a separate repository.
Publications
Suffoletto B, Preiksaitis C, Kim D, Rose C, Pitre V, Pillai N, Mandal M. AI counseling agent for motivational interviewing: Conversational processes associated with change talk in emergency department patients. J Subst Use Addict Treat. 2026 Nov;190:210053. doi: 10.1016/j.josat.2026.210053. Epub 2026 Jun 12.
PubMed 42285418Suffoletto B, Prieksaitis C, Rose C, Kim D, Pillai N, Pitre V. Feasibility and Acceptability of a Large Language Model-Based Motivational Interviewing Agent in the Emergency Department. Ann Emerg Med. 2026 Jan;87(1):121-123. doi: 10.1016/j.annemergmed.2025.08.021. Epub 2025 Oct 2. No abstract available.
PubMed 41037040
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of an AI Intervention to Help Individuals With Risky Alcohol Use Among Emergency Department Patients
- ClinicalTrials.gov ID
- NCT07661563
- Acronym / sponsor ID
- MICA-ED / 86953
- Conditions
- Alcohol Misuse
- Keywords
- alcohol, emergency department, adults, AI, motivational interviewing, text messaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 22 Jun 2026 (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 a novel digital strategy combining a generative AI counseling agent (MICA) and weekly SMS boosters works to reduce risky drinking among Emergency Department patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MICA | Experimental | Behavioral: MICAMICA is a generative AI-powered counseling agent that delivers brief Motivational Interviewing (MI)-consistent sessions, following the validated MI process (engagement, focusing, evoking, planning, and closing). It uses personalized prompts to promote autonomy and evoke change talk, ending with a session summary and satisfaction check. Participants will complete a MICA session (~5-10 min) in the ED and at 3 months. |
| MICA+SMS | Experimental | Behavioral: MICA, Behavioral: TRACThis condition includes the MICA ED session, a 3-month booster, and 12 weeks of weekly SMS messages supporting self-monitoring, goal-setting, and adaptive strategies. Messages are tailored based on reported alcohol use and goal commitment, offering encouragement, feedback, and harm-reduction messaging. |
| Standard care | No intervention | –Standard ED care and as-needed referral to alcohol resources |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For men: AUDIT-C score 4+
- For women: AUDIT-C score 3+
- Owns a mobile phone
- Reads English language
Key exclusion criteria (2 listed)
- For women: current or planned pregnancy in next 12 months
- Prisoner
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 |
|---|---|---|
| MICAMICA is an AI chatbot that uses a secure API with ChatGPT and prompted to follow MI principles to support individuals in exploring and resolving ambivalence about their alcohol use. MICA follows a predefined conversational framework and steps: introduction, engagement, focusing, evoking, planning, and closing-adapted from Miller \& Rollnick's Motivational Interviewing: Helping People Change (3rd ed.). | Behavioural | MICA, MICA+SMS |
| TRACWeekly SMS check-ins designed to support goal-setting, self-monitoring, and adaptive self-regulation strategies. Beginning the Sunday after enrollment, participants will engage with an automated SMS program once weekly for 12 weeks. Prompts include reporting on the past week's alcohol use and whether they are willing to commit to a drinking limit goal for the upcoming week. Responses trigger tailored feedback. | Behavioural | MICA+SMS |
Primary outcome
Mean weekly alcohol consumption
Time frame: Baseline, 3-, 6-, and 12-month follow-ups
Participants report (1) the average number of standard alcohol drinks each day of the week. Estimated weekly alcohol consumption will be calculated as the sum of all those drinks over 7 days.
3 secondary outcomes
Number of heavy drinking days
Time frame: Baseline, 3-, 6-, and 12-month follow-ups
Max number of drinks per drinking day
Time frame: Baseline, 3-, 6-, and 12-month follow-ups
AUDIT score
Time frame: Baseline, 3-, 6, 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 42285418Suffoletto B, Preiksaitis C, Kim D, Rose C, Pitre V, Pillai N, Mandal M. AI counseling agent for motivational interviewing: Conversational processes associated with change talk in emergency department patients. J Subst Use Addict Treat. 2026 Nov;190:210053. doi: 10.1016/j.josat.2026.210053. Epub 2026 Jun 12.
- Background: PubMed 41037040Suffoletto B, Prieksaitis C, Rose C, Kim D, Pillai N, Pitre V. Feasibility and Acceptability of a Large Language Model-Based Motivational Interviewing Agent in the Emergency Department. Ann Emerg Med. 2026 Jan;87(1):121-123. doi: 10.1016/j.annemergmed.2025.08.021. Epub 2025 Oct 2. No abstract available.
- Individual participant dataSharing planned: Yes. All survey data from baseline through 12-month followups will be uploaded to the data repository (the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA). All counseling sessions and SMS data will be de-identified and kept in a separate repository.
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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.
Brian Suffoletto, MS MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MICA and TRAC in people with Alcohol Misuse, run by Stanford University 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 4 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: looking for participants now, as of the sponsor's last update on 15 Oct 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean weekly alcohol consumption (time frame: Baseline, 3-, 6-, and 12-month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07661563, which also lists 2 linked publications.
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 15 Oct 2026.