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

Trial Summary

What is the purpose of this trial?

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 efficacy of the app for vaping cessation. Participants will be screened for eligibility, then go through an 8 week treatment period where they will be given access to use the Kick-Nic! app or referred to the NCI Quit Vaping website. This will be followed by 1, 2, 3, and 6 month follow up visits. Qualitative interviews with participants and school staff will also be conducted to obtain feedback on the app and best ways to implement/disseminate the app. Abstinence rates will be assessed biweekly during treatment including at end of treatment (EOT), and then at 1, 2, 3 and 6 month follow ups (FU). Biochemical verification (salivary cotinine \< 30 ng.ml) of self-reports of abstinence will be conducted at EOT and 6-month FU.

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 data supports the effectiveness of the treatment Kick-Nic! for quitting vaping?

Research shows that smartphone apps can help people quit smoking by providing support and improving adherence to nicotine replacement therapy (NRT). Since vaping involves nicotine, similar app-based interventions may also help people quit vaping by offering real-time support and tracking usage. ^{1 2 3 4 5}

How is the Kick-Nic! treatment for quitting vaping different from other treatments?

Kick-Nic! is unique because it is an app designed specifically for quitting vaping, whereas most existing apps and treatments focus on smoking cessation. This app likely uses interactive and personalized features to engage users, similar to other smoking cessation apps, but tailored for vaping. ^{6 7 8 9 10}

Research Team

Suchitra Krishnan-Sarin, Ph.D.

Principal Investigator

Yale University School of Medicine, Dept of Psychiatry

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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 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]

References

1. England 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. [2022]

2. England 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. [2023]

3. Canada 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Cigbreak Free: Game to Quit Smoking. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

Clickotine, A Personalized Smartphone App for Smoking Cessation: Initial Evaluation. [2022]

10. England pubmed.ncbi.nlm.nih.gov

NHS quit smoking. [2016]