| Registry | NCT06965296 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 100 (Estimated) |
| Sponsor | State University of New York at Buffalo (Other); collaborators: National Cancer Institute (NCI), Advanced Bionics |
| Conditions | Nicotine Dependence, Cigarettes |
| Interventions | AI-enhanced smartphone app, AI-enhanced smartphone app, but with delayed access (Behavioral) |
| Dates | start 2026-08-24 (estimated), primary completion 2027-02-28 (estimated), completion 2027-06-30 (estimated), first posted 2025-05-11, last updated 2026-08-06 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Nicotine Dependence, Cigarettes All trials of AI-enhanced smartphone app All trials of AI-enhanced smartphone app, but with delayed access
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?
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Immediate-Intervention Group | Experimental | Behavioral: AI-enhanced smartphone app | Participants 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. |
| Delayed-Intervention Group | Active comparator | Behavioral: AI-enhanced smartphone app, but with delayed access | Participants 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. |
Sex: All, ages: 14 Years to 20 Years
Inclusion Criteria * 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 Exclusion Criteria * 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
| Facility | City | Country | Status |
|---|---|---|---|
| University at Buffalo, School of Nursing | Buffalo, New York | United States |
NIH grants: R34CA287720