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Alcohol Use DisorderNCT07214831

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

A study testing Large language model-based chatbot brief alcohol intervention session in people with Alcohol Use Disorder, run by Massachusetts General Hospital at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 29 years
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Large language model-based chatbot brief alcohol intervention session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Jun 2027to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 29 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alex M Russell, PhD contact

617-724-0924

arussell11@mgh.harvard.edu

Samuel F Acuff, PhD contact

sacuff@mgh.harvard.edu

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Research Coordinator, 617-724-0924

Other trials in United States

About this study

Official title: A Feasibility and Acceptability Study of a Large Language Model-based Conversational Agent 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.

Read the detailed description

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.

Being tested
Large language model-based chatbot brief alcohol intervention session
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Large language model-based chatbot brief alcohol intervention sessionBehavioural

    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.

Study groups in NCT07214831
Study groupRoleWhat they receive
Large language model-based chatbot brief alcohol interventionExperimentalAll participants will interact with a large language model-based chatbot designed to deliver a brief alcohol intervention session.
Receives: Behavioral: Large language model-based chatbot brief alcohol intervention session

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to achieve target enrollment

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

    Measured: Enrollment

  2. Rate of participant retention

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

    Measured: 1-month post intervention1-month post intervention

  3. Acceptability (System Usability Scale)

    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.

    Measured: Immediate post-intervention session

  4. Acceptability - intervention delivery method

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

    Measured: Immediate post-intervention session

  5. Acceptability - usable

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

    Measured: Immediate post-intervention session

  6. Acceptability - helpful

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

    Measured: Immediate post-intervention session

  7. Acceptability - recommend to others

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

    Measured: Immediate post-intervention session

Secondary outcomes (6)

  1. Motivation to change drinking (Readiness Ruler)

    Motivation to change drinking will measured using the Readiness Ruler.

    Measured: Enrollment, immediate post-intervention session, and 1 month post-intervention

  2. Daily drinking questionnaire (DDQ)

    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.

    Measured: Enrollment and 1 month post-intervention

  3. Alcohol Use Disorders Identification Test (AUDIT)

    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.

    Measured: Enrollment and 1 month post-intervention

  4. Young Adult Alcohol Consequences Questionnaire (YAACQ)

    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.

    Measured: Enrollment and 1 month post-intervention

  5. Protective behavioral strategies scale (PBSS)

    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).

    Measured: Enrollment and 1 month post-intervention

  6. Alcohol treatment utilization

    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.

    Measured: Enrollment and 1 month post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2025
  2. Study start1 Jun 2027 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07214831
Sponsor's protocol ID
2025P001459
Other IDs
R34AA032472
Status last verified
Oct 2025
First submitted
6 Oct 2025
Last updated
22 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be submitted to the NIAAA Data Archive in accordance with NIH requirements.

Questions about this trial

What is this clinical trial studying?

A study testing Large language model-based chatbot brief alcohol intervention session in people with Alcohol Use Disorder, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alex M Russell, PhD (617-724-0924, arussell11@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to achieve target enrollment (time frame: Enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07214831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.

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