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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Standard care | No Intervention | Standard ED care and as-needed referral to alcohol resources |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MICA | Behavioral | 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.). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean weekly alcohol consumption | Participants report (1) the average number of days per week they consumed alcohol and (2) the typical number of standard drinks consumed on a drinking day. Estimated weekly alcohol consumption will be calculated as: Mean weekly drinks = (average drinking days per week) × (typical drinks per drinking day) | Baseline, 3-, 6-, and 12-month follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| 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)?" | Baseline, 3-, 6-, and 12-month follow-ups |
| Number of drinks per drinking day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Suffoletto, MS MS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42285418 | Background | Suffoletto B, Prieksaitis 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 Jun 12:210053. doi: 10.1016/j.josat.2026.210053. Online ahead of print. | |
| 41037040 | Background |
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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.
Data will be available within 1 year of study completion and available indefinitely.
Individuals with appropriate ethical approval and access to the NIAAADA or a DUA with the PI.
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C011934 | mica |
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| TRAC | Behavioral | 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. |
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Asking participants, "Over the past 30 days, on a typical drinking day, how many drinks did you have?"
| Baseline, 3-, 6-, and 12-month follow-ups |
| 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. |