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
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