Not yet recruiting NCT07661563
Advancing Scalable Alcohol Brief Interventions in the ED: A Trial of Conversational AI With Digital Reinforcements
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MICA, TRAC.
- Who it may be relevant to
- Registry conditions: Alcohol Misuse. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Trial of an AI Intervention to Help Individuals With Risky Alcohol Use Among Emergency Department Patients
Overview
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.
Interventions
- Behavioral MICA
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.). - Behavioral TRAC
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.
Primary outcome measures
- Mean weekly alcohol consumption [Time frame: Baseline, 3-, 6-, and 12-month follow-ups]
Secondary outcome measures (2)
- Number of heavy drinking days [Time frame: Baseline, 3-, 6-, and 12-month follow-ups]
- Number of drinks per drinking day [Time frame: Baseline, 3-, 6-, and 12-month follow-ups]
Eligibility criteria
Inclusion criteria
- For men: 1+ days with 5 or more drinks OR any week with 14+ drinks/week in the past 3 months
- For women: 1+ days with 4 or more drinks OR any week with 7+ drinks/week in the past 3 months
- Owns a mobile phone
- Reads English language
Exclusion criteria
- For women: current or planned pregnancy in next 12 months
- Prisoner or active military status
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Stanford University Medical Center — Palo Alto
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 Jun 12;190:210053. doi: 10.1016/j.josat.2026.210053. Online ahead of print. PMID 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. PMID 41037040
Identifiers
NCT: NCT07661563 · 86953