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Nicotine Dependence, CigarettesNCT06965296

AI-Enhanced App-based Intervention for Adolescent E-cigarette Cessation

A study testing AI-enhanced smartphone app and AI-enhanced smartphone app, but with delayed access in people with Nicotine Dependence, Cigarettes, run by State University of New York at Buffalo 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

The goal of this quasi-experimental study is to test if a smartphone app can help adolescents aged 14-20 quit e-cigarettes. The main questions it aims to answer are: Can the app help adolescents manage cravings and increase their readiness to quit? Does the personalized and real-time support provided by the app… Read more about this study

Who is it for?
Ages 14 to 20 years
Conditions the study is for
Nicotine Dependence, Cigarettes
What is being tested?
AI-enhanced smartphone app and AI-enhanced smartphone app, but with delayed access
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
24 Aug 2026to 30 Jun 2027
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 14 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adolescents who are 14 to 20 years old
  • Currently use nicotine-containing e-cigarettes (those responding "Yes" to: Have you used an electronic vaping product such as PuffBar, ElfBar, Lost Mary, JUUL, Vuse, e-cigarettes, vapes, vape pens, e-cigars, e-hookahs, hookah pens, or mods at least 1 day in the last 30 days? [CDC, 2020])
  • Interested in participating in an e-cigarette use cessation program
  • Owners of an iPhone or Android smartphone who use their phone daily
  • Able to read English

Who cannot join

  • Individuals who fall outside the age range of 14 to 20 years
  • Those who have not used a nicotine-containing e-cigarette in the past 30 days
  • Individuals not interested in participating in an e-cigarette cessation program
  • Adolescents who do not own or regularly use an iPhone or Android smartphone
  • Non-English speakers

Trial locations and contacts

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

Eunhee Park, PhD, RN contact

716-829-3701

eunheepa@buffalo.edu

United States1 site
  • University at Buffalo, School of Nursing

    Buffalo, New York, 14214

    Eunhee Park, PhD, RN, 716-829-3701, eunheepa@buffalo.edu

    Eunhee Park, PhD, RN

Other trials in United States

About this study

The goal of this quasi-experimental study is to test if a smartphone app can help adolescents aged 14-20 quit e-cigarettes. The main questions it aims to answer are:

  • Can the app help adolescents manage cravings and increase their readiness to quit?
  • Does the personalized and real-time support provided by the app improve their success in quitting e-cigarettes?
Read more

Researchers will compare two groups: an immediate-intervention group that starts using the app right away and a delayed-intervention group that begins after three months, to see if the timing of app access influences outcomes in e-cigarette cessation.

Participants will:

  • Set personal goals and track their daily progress within the app.
  • Use a real-time "urge" feature that provides immediate support during cravings.
  • Engage with a chatbot for quick answers and motivational support around quitting.

This study aims to create an accessible, personalized tool to help adolescents reduce or quit e-cigarette use, exploring its feasibility as a broader intervention model.

Read the detailed description

This quasi-experimental study aims to develop and evaluate an AI-enhanced smartphone app designed to support adolescents aged 14-20 in quitting e-cigarettes. Given the high prevalence of e-cigarette use among youth, this app-based intervention focuses on providing personalized, real-time support for cravings and motivation to quit. The app integrates interactive features to engage users and is designed for scalability, enabling wide-reaching impact in various settings such as schools, clinics, and communities.

Study Phases and Objectives

Phase 1: Development and Usability Testing Phase 1 focuses on refining an existing beta version of the app. In this formative stage, the app's design, content, and features will be adjusted based on adolescent feedback to ensure it is user-friendly and engaging. Participants will test the app and provide insights through usability surveys and interviews, which will inform necessary changes.

Key activities in this phase include:

  • Gathering feedback on usability and design.
  • Modifying app features to better meet the preferences and needs of adolescent users.
  • Finalizing the app to meet high usability benchmarks for deployment in the next phase.

Phase 2: Clinical Feasibility Testing In Phase 2, the app's effectiveness will be tested using a quasi-randomized design with two groups: one group of participants will begin using the app immediately, while the second group will start after a three-month delay. This approach will help determine if earlier access to the intervention leads to improved outcomes in terms of e-cigarette cessation.

The study will assess how the app impacts participants' readiness to quit, actual quitting attempts, and ongoing motivation over time. Engagement levels with the app's features, such as real-time craving support and AI-driven educational modules, will also be tracked to evaluate the intervention's overall feasibility and appeal.

App Features and Personalization

The app's core features include:

  1. Goal Setting and Progress Tracking: Users set personal quitting goals, track their progress, and access daily training modules to build skills for managing cravings and quitting.
  2. Real-Time Craving Management: The "urge" feature provides immediate support during cravings, using mindfulness exercises and coping strategies tailored to each user's needs.
  3. AI Chatbot Support: A chatbot offers 24/7 assistance, answering questions and providing motivation based on users' quitting status and individual characteristics.

These AI-driven tools are customized according to user data and interactions within the app, ensuring the intervention feels personal and responsive to each user's progress.

Data Collection and Analysis Data will be collected on app usage, engagement with specific features, and changes in e-cigarette use over time. Analysis will include both user feedback and statistical evaluation of the app's impact on participants' quitting success. Insights from this data will contribute to the ongoing refinement of the app and inform its potential for broader use as an adolescent-focused e-cigarette cessation tool.

Anticipated Impact This study aims to create a user-friendly, scalable app that leverages AI to support adolescents in quitting e-cigarettes effectively. If successful, this digital intervention could be a valuable resource for youth cessation programs and serve as a model for similar health-related app-based interventions.

Being tested
AI-enhanced smartphone app, AI-enhanced smartphone app, but with delayed access
Keywords
Adolescent e-cigarette use, E-cigarette cessation, Smartphone app, Digital health intervention, Personalized health support
Medical subject headings
Tobacco Use Disorder

What participants receive

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

  • AI-enhanced smartphone appBehavioural

    A smartphone app has been developed and is in keeping with guideline recommendations for the treatment of e-cigarette products. This app has a user-friendly Graphic User Interface (GUI) to allow users to build their own accounts and individualized contents conveniently, based on the input the users initially provide including e-cigarette use patterns, readiness to quit e-cigarette, beliefs about e-cigarette, nicotine addiction, self-efficacy, other substance use status, and parental or peer e-cigarette use status.

    The proposed AI model in this app will learn information from the input data, including progress toward e-cigarette cessation (e,g, changes of readiness of quitting, quit attempts), and additional data including emotional status, stress level, feedback to the previous learning modules, and then predict the result on the fly. Based on the predicted result, the app will send in-time motivational messages and mindfulness training modules.

  • AI-enhanced smartphone app, but with delayed accessBehavioural

    Participants in the control group will be placed on a three-month waitlist. After this period, they will receive access to the same app-based intervention as the immediate intervention group, allowing a comparison between immediate and delayed access.

Study groups in NCT06965296
Study groupRoleWhat they receive
Immediate-Intervention GroupExperimentalParticipants in this arm will begin using the AI-enhanced smartphone app immediately after enrollment. This arm serves to assess the initial impact and feasibility of the app as a tool for e-cigarette cessation among adolescents.
Receives: Behavioral: AI-enhanced smartphone app
Delayed-Intervention GroupActive comparatorParticipants in this arm will wait three months after enrollment before using the AI-enhanced smartphone app. This arm serves as a delayed control, allowing comparison with the immediate-intervention group to understand the impact of timing on quitting success.
Receives: Behavioral: AI-enhanced smartphone app, but with delayed access

What is being measured

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

  1. Usability

    The usability of the intervention will be assessed using the mHealth App Usability Questionnaire, a 21-item instrument designed for interactive mobile health apps. It measures three domains: ease of use and satisfaction, system information arrangement, and usefulness. Each item is rated on a 5-point Likert scale, yielding a total score range of 21 to 105, with higher scores indicating better usability. An open-ended question will also be included at the end of the survey to gather suggestions for app improvement.

    Measured: 30-Day Follow-up

Secondary outcomes (7)
  1. Engagement - Frequency of App Use

    Automatically recorded log data from the app will track each login event by a participant.

    Measured: 30-Day and 3-Month Follow-up

  2. Engagement - Minutes of App Use

    Cumulative minutes of app usage will be captured via app log data.

    Measured: 30-Day and 3-Month Follow-up

  3. E-cigarette Use

    Self-reported number of days participants used e-cigarettes in the past 30 days. Responses range from 0 to 30 days.

    Measured: 30-day and 3-month follow up

  4. Quit attempts

    Self-reported number of quit attempts in the past 30 days, along with the longest duration of abstinence.

    Measured: 30-Day and 3-Month Follow-up

  5. Readiness to Quit

    Readiness to quit will be assessed using a modified Contemplation Ladder. The Contemplation Ladder ranges from 0 (no thought of quitting) to 10 (taking action to quit). Higher scores indicate greater readiness.

    Measured: 30-Day and 3-Month Follow-up

  6. Nicotine Dependence

    Measured using the Penn State Electronic Cigarette Dependence Index (PSECDI), a 10-item scale with a total score range of 0 to 20. Higher scores indicate higher levels of nicotine dependence.

    Measured: 30-Day and 3-Month Follow-up

  7. Beliefs About E-Cigarettes

    Assessed using a questions from the National Youth Tobacco Survey about e-cigarette harm, addictiveness, and benefits.

    Measured: 30-Day and 3-Month Follow-up

Timeline

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

  1. First posted11 May 2025
  2. Study start24 Aug 2026 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Jun 2027 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study involves two groups: an immediate-intervention group that starts using the app immediately and a delayed-intervention group that begins after three months. Each group is assigned to its respective intervention timeline at the start and follows it independently of the other group, without switching or crossover.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06965296
Sponsor's protocol ID
1R34CA287720-01A1
Other IDs
1R34CA287720-01A1
Status last verified
Aug 2026
First submitted
6 Mar 2025
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hebert ET, Ra CK, Alexander AC, Helt A, Moisiuc R, Kendzor DE, Vidrine DJ, Funk-Lawler RK, Businelle MS. A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Mar 9;22(3):e16907. doi: 10.2196/16907.

    PubMed 32149716
  • Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

    PubMed 23961782
  • Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.

    PubMed 29403314
  • Baskerville NB, Struik LL, Guindon GE, Norman CD, Whittaker R, Burns C, Hammond D, Dash D, Brown KS. Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Oct 23;6(10):e10893. doi: 10.2196/10893.

    PubMed 30355563
  • Audrain-McGovern J, Rodriguez D, Pianin S, Alexander E. Initial e-cigarette flavoring and nicotine exposure and e-cigarette uptake among adolescents. Drug Alcohol Depend. 2019 Sep 1;202:149-155. doi: 10.1016/j.drugalcdep.2019.04.037. Epub 2019 Jul 19.

    PubMed 31351341

Questions about this trial

What is this clinical trial studying?

A study testing AI-enhanced smartphone app and AI-enhanced smartphone app, but with delayed access in people with Nicotine Dependence, Cigarettes, run by State University of New York at Buffalo 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 5 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 6 Aug 2026. 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 Eunhee Park, PhD, RN (716-829-3701, eunheepa@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability (time frame: 30-Day Follow-up). 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 NCT06965296, which also lists 5 linked publications.

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 6 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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