Kick-Nic! Youth Quit Vaping App

July 29, 2026 updated by: Yale University

Vaping Cessation Among Youth: Evaluating the Kick-Nic! App

High school and middle 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 1.5, 3, 4.5 and then 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 1.5, 3, 4.5 and then 6 months follow ups (FU). Biochemical verification (salivary cotinine < 30 ng.ml) of self-reports of abstinence will be conducted at EOT and 6-month FU.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Youth will be randomized to receive the Kick-Nic!© app (ACTIVE group) or a CONTROL assessment condition who will be given referrals to the NCI Quit Vaping webpage.

Description of NCI Quit Vaping webpage: The NCI webpage provides quitting tobacco resources for youth, including for e-cigarettes. Importantly, the information provided is similar to the CBT (Cognitive Behavioral Therapy) skills modeled by the Kick-Nic! © app. The Quit Vaping section provides education/modules on how to quit vaping including 1) "build my quit plan", 2) "get a vaping reality check", 3) "how to quit vaping", 4) "your first day without vaping", 5) "deal with vape cravings", 6) "understand your vape triggers", 7) "vaping addiction and nicotine withdrawal", 8) "anxiety, stress and vaping", and 9) "depression and vaping". Adolescents have the option of speaking to an NCI LiveHelp specialist, and access to a Quitline number (800-QUIT-NOW) which can provide further access to counselors.

ACTIVE group participants will be introduced to the app. They will receive instructions on logging in, navigation and will receive a FAQ sheet (via text or email) that will detail this information. They will receive standard advice to avoid use of other tobacco products, cannabis, or e-cigarettes without nicotine. Participants will be asked to use the app over an 8-week period, complete one module each week, and practice the skills that they learned between modules. They will be told that the app will help them set a quit day and that they should complete the first two modules which would teach them how to prepare for quitting before their quit day.

Engagement will be encouraged using text/motivational messages and weekly personal check-ins. Additionally, participants will also receive weekly personal check-ins during the 8-week treatment period which will be conducted by research staff and will use voice or video calls (preferably) or text (depending on the participant's preference) and a standardized script for various scenarios. Staff will check in on whether participants completed the modules. If not, they will provide support to address any barriers to completing the modules, motivational messages to encourage module completion and to practice skills they will learn. If participants have completed the module that was due to be completed that week, they will receive motivational messages to encourage them to practice the skills they learned. The check-ins will not provide any further quit advice (to avoid interfering with the content of the app).

Assessments will be obtained at baseline (week 0; treatment initiation), every two weeks (weeks 2, 4, 6, 8) during the treatment period, and then at 1.5, 3, 4.5 and then 6 months follow up timepoints by research assistants who will be blind to the randomization condition.

Qualitative interviews will be conducted with up to 50% of participants in the ACTIVE group to assess adolescent perspectives of the app and on how the intervention should be disseminated to maximize reach and engagement of high school youth.

CONTROL group participants will be introduced to the NCI webpage and asked to use those resources during the 8-week period and will be scheduled to complete assessments on the same schedule as the ACTIVE group. They will not complete interviews.

Study Type

Interventional

Enrollment (Estimated)

306

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University School of Medicine (Connecticut Mental Health Center)
        • Principal Investigator:
          • Suchitra Krishnan-Sarin, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. high school or middle school aged youth (12-19 years old),
  2. regular current (past month) e-cig users using nicotine-containing e-cigs at least 1 day/week.
  3. want to quit using e-cigarettes.
  4. have a smartphone with data/WIFI plan in order to access and utilize the KickNic! app

Exclusion Criteria:

  • Those who have non-stable (<2 months) use of anxiolytics, antidepressants, and other psychostimulants or have a history of psychosis or any significant current psychiatric/medical condition that would increase risk will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACTIVE
Participants in the active group will be given access to the Kick-Nic! app to use for vaping cessation.
Behavioral: Kick-Nic! mobile phone application
The Kick-Nic! app has seven modules that cover core CBT strategies using skills, graphic illustrations, and interactive components to help adolescents quit using e-cigarettes.
Active Comparator: CONTROL
Participants in the control group will be referred to the NCI Quit Vaping website.
Behavioral: NCI Quit Vaping website
The NCI webpage provides quitting tobacco resources for youth, including for e-cigarettes. The information provided is similar to the CBT skills modeled by the Kick-Nic! app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeline Follow Back (self-report) with saliva cotinine (biochemical verification) at 6 month follow up.
Time Frame: 6 month follow up study visit.
Timeline Follow Back (self-report) determining 7-day point prevalence of e-cigarette use confirmed by saliva cotinine <30ng/mL at 6 month follow up visit.
6 month follow up study visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeline Follow Back (self-report) with saliva cotinine (biochemical verification) at End of Treatment (EOT).
Time Frame: EOT (8 weeks).
Timeline Follow Back (self-report) determining 7-day point prevalence of e-cigarette use confirmed by saliva cotinine <30ng/mL at EOT visit.
EOT (8 weeks).
Timeline Follow Back (self-report) at EOT, 3, and 6 month follow up
Time Frame: EOT (8 weeks), 3 month follow up, and 6 month follow up.
Timeline Follow Back (self-report) will be used to determine % days e-cigarette free and continuous abstinence of e-cigarette use at EOT, 3 month, and 6 month follow up.
EOT (8 weeks), 3 month follow up, and 6 month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Suchitra Krishnan-Sarin, Ph.D., Yale University School of Medicine, Dept of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000035028
  • 1R01CA285216-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data that underlie results in a publication may be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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