Kick-Nic! Youth Quit Vaping App

NCT06662305 | Recruiting Phase 2 DMC

• 2 other identifiers: 20000350281R01CA285216-01A1
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Vaping

Outcome Measures

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.

  6 month follow up study visit.

Secondary Outcomes (2)

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

  EOT (8 weeks).

• Timeline Follow Back (self-report) at EOT, 3, and 6 month follow up

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

Study Arms (2)

ACTIVE

EXPERIMENTAL

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

CONTROL

ACTIVE COMPARATOR

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

Behavioral: NCI Quit Vaping website

Interventions

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.

ACTIVE

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.

CONTROL

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• high school aged youth (13-19 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Yale University: lead

Study Sites (1)

Yale University School of Medicine (Connecticut Mental Health Center)

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Suchitra Krishnan-Sarin, Ph.D.

  Yale University School of Medicine, Dept of Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Liss

CONTACT

2034447545; thomas.liss@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into an ACTIVE group or CONTROL group.

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 28, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)