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Not yet recruitingNCT07661563MICA-EDUpdated Sep 30, 2026

Advancing Scalable Alcohol Brief Interventions in the ED: A Trial of Conversational AI With Digital Reinforcements

An interventional study of MICA and TRAC in Alcohol Misuse, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Stanford University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alcohol Misuse

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Keywords

  • alcohol
  • emergency department
  • adults
  • AI
  • motivational interviewing
  • text messaging
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. For men: AUDIT-C score 4+
  2. For women: AUDIT-C score 3+
  3. Owns a mobile phone
  4. Reads English language

Exclusion criteria

Exclusion Criteria:

  1. For women: current or planned pregnancy in next 12 months
  2. Prisoner
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
750 participants (estimated)

Study arms

  • Experimental
    MICA

    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.

    Behavioral: MICA

  • Experimental
    MICA+SMS

    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.

    Behavioral: MICA · Behavioral: TRAC

  • No intervention
    Standard care

    Standard ED care and as-needed referral to alcohol resources

Interventions

  • BehavioralMICA

    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.).

  • BehavioralTRAC

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 3-, 6-, and 12-month follow-ups

Secondary outcomes

  1. 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)?"

    Time frame: Baseline, 3-, 6-, and 12-month follow-ups

  2. 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?"

    Time frame: Baseline, 3-, 6-, and 12-month follow-ups

  3. AUDIT score

    Alcohol Use Disorders Identification Test (AUDIT) is a 10 question screen for AUD

    Time frame: Baseline, 3-, 6, 12-months

Other outcomes

  1. SIP-2R

    Short Inventory of Problems (SIP-2R) is a 15-item questionnaire used to measure the negative consequences and harm caused by drinking alcohol

    Time frame: Baseline, 3-, 6-, and 12-months

06

Study locations

1 site
  • Stanford University Medical Center
    Palo Alto, California 94304, United States
07

References and documents

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 42285418 ↗
  • Suffoletto 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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT07661563
Lead sponsor
Stanford University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Brian Suffoletto (Professor, Emergency Medicine, Stanford University) — Principal investigator
First posted
Jun 22, 2026
Start date
Oct 2026 (estimated)
Primary completion
Aug 2030 (estimated)
Completion
Feb 2031 (estimated)
Last update
Sep 30, 2026

Study contacts

Brian Suffoletto, MS MS
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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