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NCT Number: NCT07214831

A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerging Adults

American emerging adults (EAs; aged 18-29 years) have the highest rates of alcohol use disorder (AUD) and the lowest levels of treatment engagement of any age group. Innovative, scalable, and cost-effective strategies are needed to expand early detection and intervention for EAs engaged in patterns of drinking associated with AUD. Because digital technology use is frequent among EAs, digital interventions may be a particularly suitable way to reach this population. Prior studies of digital alcohol interventions demonstrate modest but consistent reductions in alcohol use, but these tools are often limited by a lack of interactivity and personalization. Large language model (LLM)-based chatbots, such as ChatGPT, may address these limitations by enabling personalized, adaptive, and human-like engagement. These features have the potential to increase uptake and engagement with screening and brief interventions among EAs. This study will develop, validate, and conduct an open trial of an LLM-based chatbot-delivered brief intervention designed to reduce alcohol use and problems among EAs, with the primary goal of establishing preliminary feasibility and acceptability.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location contact

Research Coordinator

CONTACT

617-724-0924

About this study

This feasibility and acceptability study will develop, validate, and conduct a Phase I single-arm open trial of a large language model (LLM)-based chatbot-delivered brief intervention designed to reduce alcohol use and problems among EAs. To develop the augmented LLM, the investigators will use instruction fine-tuning to enhance conversational abilities within the context of brief interventions based on high-fidelity recordings of sessions from prior clinical trials and simulated patient-provider interactions. A retrieval augmented generation system will be developed to ensure the model delivers accurate information. The augmented LLM will be incorporated into a chatbot interface delivered through a user-friendly web application. To validate the chatbot's capability for delivering brief alcohol interventions, patient actors (clinical or counseling psychology PhD students) will be assigned clinical vignettes depicting diverse EAs with patterns of drinking associated with alcohol use disorder. Patient actors will engage in two randomly ordered online text-based brief intervention sessions for each vignette (one with the chatbot and one with a human clinician). Blinded transcripts from sessions will be reviewed by experts to assess treatment fidelity. To maximize and test initial feasibility and acceptability of the intervention, the investigators will conduct semi-structured interviews with 20 EAs who report hazardous drinking, followed by an open trial with another 20 EAs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-29 years old
  • Engaged in past-month hazardous drinking (consuming ≥ 5/4 drinks for men/women on two or more occasions in the past month) or exceeded recommended guidelines for risky drinking (> 14/7 drinks per week for men/women)
  • Able to read and comprehend English at a 5th grade level

Exclusion criteria

  • Report a history of or active psychosis
  • Previous or current engagement in alcohol or drug treatment
  • Risk for alcohol withdrawal as evidenced by very heavy weekly drinking reports on the alcohol screener (> 40 standard drinks in a typical week in the past month)
  • Demonstrate inability or unwillingness to attend in-person office visits
  • Demonstrate inability or unwillingness to identify an emergency contact who could be contacted in case the participant becomes lost to follow-up

Treatment and study plan

Large language model-based chatbot brief alcohol intervention session

Behavioral

The intervention is a large language model-based chatbot designed to delivered brief alcohol interventions using motivational interviewing-consistent strategies. The chatbot session will last approximately 45 minutes and will include a decisional balance exercise, feedback on drinking patterns, normative beliefs about drinking, alcohol-related consequences, goal setting, and harm-reduction strategies.

Primary outcomes

  1. Time to achieve target enrollment

    Time frame: Enrollment

    Recruitment feasibility will be evaluated based on the length of time needed to recruit target enrollment (N = 20)

  2. Rate of participant retention

    Time frame: 1-month post intervention1-month post intervention

    Retention feasibility will be achieved if >80% of participants who consented to participating in the study complete one-month follow-up assessment.

  3. Acceptability (System Usability Scale)

    Time frame: Immediate post-intervention session

    Acceptability of the conversational agent-delivered intervention will be measured using the 10-item System Usability Scale. Each question is rated on a Likert-type scale ranging from (1) strongly disagree to (5) strongly agree.

  4. Acceptability - intervention delivery method

    Time frame: Immediate post-intervention session

    Percentage of participants who agree or strongly agree the intervention delivery method was acceptable

  5. Acceptability - usable

    Time frame: Immediate post-intervention session

    Percentage of participants who agree or strongly agree the intervention was easy to interact with

  6. Acceptability - helpful

    Time frame: Immediate post-intervention session

    Percentage of participants who agree or strongly agree the intervention was helpful

  7. Acceptability - recommend to others

    Time frame: Immediate post-intervention session

    Percentage of participants who agree or strongly agree they would recommend the chatbot to others

Secondary outcomes

  1. Motivation to change drinking (Readiness Ruler)

    Time frame: Enrollment, immediate post-intervention session, and 1 month post-intervention

    Motivation to change drinking will measured using the Readiness Ruler.

  2. Daily drinking questionnaire (DDQ)

    Time frame: Enrollment and 1 month post-intervention

    Past-month typical drinks per week and frequency of heavy drinking will be assessed using the DDQ. Respondents are asked to record the number of drinks they consume each day of a typical week over the previous month.

  3. Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: Enrollment and 1 month post-intervention

    Past-month frequency of heavy drinking will be assessed using the AUDIT, a 10-item screening tool used to identify hazardous and harmful drinking patterns. Total scores range from 0 to 40, with higher scores indicating more hazardous or harmful drinking patterns.

  4. Young Adult Alcohol Consequences Questionnaire (YAACQ)

    Time frame: Enrollment and 1 month post-intervention

    Alcohol-related problems will be assessed using the YAACQ. Respondents will be asked to indicate (yes/no) which of the 48 potential problems they have experienced as a result of their drinking over the previous month.

  5. Protective behavioral strategies scale (PBSS)

    Time frame: Enrollment and 1 month post-intervention

    Protective behavioral strategies will be assessed using the 15-item PBSS. Participants will be asked to indicate how often they used each strategy when drinking alcohol during the previous month. Response options are presented on a 6-point Likert type scale ranging from 1 (never) to 6 (always).

  6. Alcohol treatment utilization

    Time frame: Enrollment and 1 month post-intervention

    Alcohol treatment utilization, including a variety of options, will be measured by asking respondents to indicate (yes/no) which of the potential options they have utilized.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex M Russell, PhD

CONTACT

[email protected]

617-724-0924

Samuel F Acuff, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

A Feasibility and Acceptability Study of a Large Language Model-based Conversational Agent for Brief Alcohol Intervention Among Emerging Adults

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Oct 9, 2025
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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