Health TrialsbyHealthPanel

Kick-Nic! Youth Quit Vaping App

ConditionNicotine Vaping
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-19
SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

high school or middle school aged youth (12-19 years old),

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

want to quit using e-cigarettes.

have a smartphone with data/WIFI plan in order to access and utilize the KickNic! app

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kick-Nic! mobile phone application

    Behavioral

    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

    Behavioral

    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.

Treatment groups

306 Participants
are divided into 2 treatment groups
Group A: ACTIVEExperimental treatment 1 intervention
Group B: CONTROLActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Timeline Follow Back (self-report) with saliva cotinine (biochemical verification) at 6 month follow up.

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.

Time frame
6 month follow up study visit.

Secondary outcomes

1

Timeline Follow Back (self-report) with saliva cotinine (biochemical verification) at End of Treatment (EOT).

Timeline Follow Back (self-report) determining 7-day point prevalence of e-cigarette use confirmed by saliva cotinine \<30ng/mL at EOT visit.

Time frame
EOT (8 weeks).
2

Timeline Follow Back (self-report) at EOT, 3, 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.

Time frame
EOT (8 weeks), 3 month follow up, and 6 month follow up.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now