Kick-Nic! App for Quitting Vaping

Overseen By Thomas Liss

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Anxiolytics, Antidepressants, Psychostimulants

Disqualifiers: Psychosis, Psychiatric/medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

306 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called Kick-Nic!, designed to help high school students quit vaping. Participants will either use the app or be referred to a website to determine which method aids more in quitting. The trial seeks high school students who use e-cigarettes with nicotine at least once a week and want to quit. Participants need a smartphone with internet access to use the app. The trial will monitor participants for several months to assess the app's effectiveness. As a Phase 2 trial, this research focuses on evaluating the app's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been using anxiolytics, antidepressants, or other psychostimulants for less than 2 months, you may not be eligible to participate.

What prior data suggests that the Kick-Nic! app is safe for high school students?

Research has shown that digital tools like the Kick-Nic! app are generally safe for users. Studies on similar apps for quitting vaping have found that people use them without problems. Unlike some medications, these apps don't cause physical side effects. Most user feedback focuses on the app's ease of use and design, rather than safety issues.

The Kick-Nic! app is currently in a Phase 2 trial, indicating that earlier studies suggested it is safe enough for testing with more people. This phase examines user responses to the app, including any possible side effects. So far, no major safety issues have been reported for digital tools like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Kick-Nic! app because it offers a fresh, tech-driven approach to quitting vaping. Unlike traditional methods that often involve counseling or nicotine replacement therapies, Kick-Nic! uses a mobile app to engage users directly on their phones, making it easily accessible and potentially more engaging. This digital approach can personalize quitting strategies, providing tailored support and motivation, which might enhance success rates for those trying to quit vaping. Additionally, the app's convenience and ability to provide real-time feedback and progress tracking are features that set it apart from other cessation methods.

What evidence suggests that the Kick-Nic! app is effective for vaping cessation?

Studies have shown that digital tools, like apps, offer a promising way to help young people quit vaping. In this trial, participants in the active group will access the Kick-Nic! app, designed specifically for high school students who want to stop vaping. Research indicates that similar app-based programs have successfully helped people quit temporarily and adhere to their quitting plans. Early results suggest these digital tools can engage users and help them stay focused. By providing personalized support and resources, the Kick-Nic! app aims to make quitting vaping easier for teens. ^{1 2 3 6 7}

Who Is on the Research Team?

Suchitra Krishnan-Sarin, Ph.D.

Principal Investigator

Yale University School of Medicine, Dept of Psychiatry

Are You a Good Fit for This Trial?

This trial is for high school students who are currently vaping and want to quit. They must be willing to participate in an 8-week program and attend follow-up visits up to 6 months after the treatment period. The study excludes individuals who do not meet these criteria.

Inclusion Criteria

I am between 13 and 19 years old.

Want to quit using e-cigarettes

Regular current (past month) e-cig users using nicotine-containing e-cigs at least 1 day/week

Exclusion Criteria

I have been on stable doses of mental health medications for over 2 months.

I do not have a history of severe mental health issues that could increase my risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Kick-Nic! app or are referred to the NCI Quit Vaping website for an 8-week period

8 weeks

4 biweekly assessments (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 1, 2, 3, and 6 months

6 months

4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Kick-Nic!

Trial Overview The Kick-Nic! Youth Quit Vaping App trial tests if a mobile app can help teens stop vaping compared to using a control website by NCI. Participants will randomly receive either the app or website access, with their progress monitored through regular check-ins and interviews.

How Is the Trial Designed?

Group I: ACTIVE Experimental Treatment 1 Intervention

Participants in the active group will be given access to the Kick-Nic! app to use for vaping cessation.

Group II: CONTROL Active Control 1 Intervention

Participants in the control group will be referred to the NCI Quit Vaping website.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Among 311,567 users of the iCoach app for smoking cessation, 26,785 steady users were identified, with more intensive app use linked to higher rates of smoking cessation, improved quitting stages, and increased self-efficacy over time.

The most significant improvements in smoking-related outcomes were observed within the first 3 months of app use, particularly among older users and women, who were more likely to engage with the app intensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Smoking Cessation App Ex-Smokers iCoach and Associations With Smoking-Related Outcomes Over Time in a Large Sample of European Smokers: Retrospective Observational Study. Mansour, MB., Busschers, WB., Crone, MR., et al.[2023]

The NHS Quit Smoking app is specifically designed to support individuals during the critical first 28 days of their smoking cessation journey, which is a crucial period for developing new habits.

The app utilizes motivational messages, progress tracking, and financial calculations to enhance user engagement and encourage successful quitting, making it a practical tool for those looking to stop smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NHS quit smoking. [2016]

The NRT2Quit smartphone app showed preliminary evidence of improving short-term smoking cessation rates and adherence to nicotine replacement therapy (NRT), with a biochemically verified quit rate of 25% in the intervention group compared to 8% in the control group, although the results were not statistically significant due to low participant numbers.

Participants using the NRT2Quit app logged in more frequently and were more likely to use NRT at follow-up (100% vs. 28.6%), suggesting that the app may enhance engagement and support for smokers trying to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence: results of a prematurely terminated study. Herbec, A., Brown, J., Shahab, L., et al.[2023]

In an initial study with 416 participants, the Clickotine app showed high engagement, with users opening the app an average of 100.6 times over 8 weeks and logging 214.4 interactions, indicating that the app effectively engages smokers in their cessation journey.

The app demonstrated promising efficacy, with 45.2% of users reporting 7-day abstinence and 26.2% reporting 30-day abstinence from smoking after 8 weeks, while only a few adverse events related to nicotine withdrawal were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clickotine, A Personalized Smartphone App for Smoking Cessation: Initial Evaluation. Iacoviello, BM., Steinerman, JR., Klein, DB., et al.[2022]

The UK's first smoking cessation app is designed as an interactive game, aiming to make the process of quitting smoking more engaging and enjoyable.

Developed by a games developer, this innovative approach may enhance user motivation and adherence to quitting strategies compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigbreak Free: Game to Quit Smoking. [2019]

A study of 252 smoking cessation apps for iPhone and 148 for Android revealed that popular apps generally have low adherence to U.S. Public Health Service guidelines, scoring an average of only 12.9 out of 42 on the Adherence Index.

None of the apps recommended calling a quitline, and only 4.1% suggested using approved medications, indicating a significant gap in evidence-based support for users trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. Abroms, LC., Lee Westmaas, J., Bontemps-Jones, J., et al.[2022]

A pilot study involving 35 pregnant women showed that the 'NicUse' smartphone app for monitoring nicotine replacement therapy (NRT) adherence was highly acceptable, with 96% of users finding it easy to use and clear in its instructions.

The data collected through NicUse demonstrated strong validity, as there was a very high correlation (r = 0.95) between the number of cigarettes reported in the app and exhaled carbon monoxide readings, indicating reliable self-reporting of smoking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and acceptability testing of an app-based smart survey system to record smoking behaviour, use of nicotine replacement therapy (NRT) and e-cigarettes. Huang, Y., Emery, J., Naughton, F., et al.[2022]

The Stop-Tabac app, designed for smoking cessation, is being tested in a large randomized trial with 5200 participants to assess its effectiveness over 6 months, providing personalized support and feedback to users.

This study aims to address the lack of evidence on the impact of health apps for smoking cessation, potentially improving access to support and compliance with nicotine therapy for smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. Etter, JF., Khazaal, Y.[2021]

Mobile health applications are effective tools for helping individuals change their smoking habits, as they provide counseling and motivation for smoking cessation.

The review analyzed 12 studies that highlighted four different technological approaches, demonstrating the versatility and potential of mobile devices in supporting smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. Kefaliakos, A., Pliakos, I., Chardalias, K., et al.[2018]

This pilot study aims to evaluate the effectiveness of a commercially available smartphone app for tobacco cessation among young adults aged 18-30 who smoke more than 5 cigarettes a day, comparing it to usual care in a hospital setting.

The study will focus on feasibility metrics such as recruitment, retention, and adherence to the app, which will inform future larger trials on the effectiveness and cost-effectiveness of mobile interventions for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial. Chu, KH., Escobar-Viera, CG., Matheny, SJ., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-2-nicotine-vaping-2025-ffdea

Kick-Nic! App for Quitting Vaping The NRT2Quit smartphone app showed preliminary evidence of improving short-term smoking cessation rates and adherence to nicotine replacement therapy (NRT), ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548964/

Exploration of Digital Interventions for Vaping Cessation Digital interventions have emerged as a promising approach to support vaping cessation, particularly among youth and young adults.

3. ctv.veeva.com ctv.veeva.com/study/kick-nic-youth-quit-vaping-app

Kick-Nic! Youth Quit Vaping App - ClinicalTrials.Veeva High school students who want to quit vaping will be randomized to receive the Kick-Nic! app or a control NCI website to determine the ...

4. mdpi.com mdpi.com/2624-8611/5/4/72

Smartphone App-Based Interventions to Support Smoking ... The effectiveness of supporting smoking cessation and user experience are the two most common outcome measures of the reviewed studies. Most studies indicated ...

5. formative.jmir.org formative.jmir.org/2024/1/e57376

Outcomes of a Comprehensive Mobile Vaping Cessation ... Outcomes included engagement and retention (ie, weeks in the program, number of Pivot app openings, and number of messages sent to the coach), ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1386505623000874

Smokers' user experience of smoking cessation apps Users were worried about the safety of their data [38], or valued anonymity ... Tailoring of a smartphone smoking cessation app (kick. it) for serious ...

7. jmir.org jmir.org/2021/10/e28303/

e-Cigarette Cessation: Content Analysis of a Quit Vaping ... This study aims to examine a quit vaping subreddit to understand how e-cigarette users are experiencing and approaching vaping cessation.