Recruiting
Phase 2

Kick-Nic!

Sponsor:

Yale University

Code:

NCT06662305

Conditions

Nicotine Vaping

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Accepted

Interventions

Kick-Nic! mobile phone application

NCI Quit Vaping website

Study Details

Brief summary:

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.

Conditions

Nicotine Vaping

Study ID

NCT06662305

Start date

Jan 7, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Accepted

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 Design

Enrollment

306 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ACTIVE

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

active comparator: CONTROL

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

Interventions

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.

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.

Primary outcome measure

  • Timeline Follow Back (self-report) with saliva cotinine (biochemical verification) at 6 month follow up. [ Time Frame: 6 month follow up study visit. ]

Central Contacts and Locations

Central contacts

Thomas Liss

2034447545thomas.liss@yale.edu

Locations

Yale University School of Medicine (Connecticut Mental Health Center)

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Thomas Liss

203-444-7545thomas.liss@yale.edu

Principal Investigator:

Suchitra Krishnan-Sarin, PhD

More Information

Sponsor

Yale University

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-31.