Nicotine VapingPhase 2NCT06662305
Kick-Nic! Youth Quit Vaping App
A Phase 2 study testing Kick-Nic! mobile phone application and NCI Quit Vaping website in people with Nicotine Vaping, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Vaping
- What is being tested?
- Kick-Nic! mobile phone application and NCI Quit Vaping website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to 31 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University School of Medicine (Connecticut Mental Health Center)
New Haven, Connecticut, 06519
Thomas Liss, 203-444-7545, thomas.liss@yale.edu
Suchitra Krishnan-Sarin, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Nicotine Vaping
- Being tested
- Kick-Nic! mobile phone application, NCI Quit Vaping website
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kick-Nic! mobile phone applicationBehavioural
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 websiteBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE | Experimental | Participants in the active group will be given access to the Kick-Nic! app to use for vaping cessation. Receives: Behavioral: Kick-Nic! mobile phone application |
| CONTROL | Active comparator | Participants in the control group will be referred to the NCI Quit Vaping website. Receives: Behavioral: NCI Quit Vaping website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month follow up study visit.
Secondary outcomes (2)
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.
Measured: EOT (8 weeks).
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.
Measured: EOT (8 weeks), 3 month follow up, and 6 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start7 Jan 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine VapingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into an ACTIVE group or CONTROL group.
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Suchitra Krishnan-Sarin, Ph.D., Principal investigator, Yale University School of Medicine, Dept of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662305
- Sponsor's protocol ID
- 2000035028
- Other IDs
- 1R01CA285216-01A1
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data that underlie results in a publication may be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaping Cessation Among Youth: Evaluating the Kick-Nic! App
- ClinicalTrials.gov ID
- NCT06662305
- Acronym / sponsor ID
- 2000035028
- Conditions
- Nicotine Vaping
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into an ACTIVE group or CONTROL group.
| Arm | Type | Receives |
|---|---|---|
| ACTIVE | Experimental | Behavioral: Kick-Nic! mobile phone applicationParticipants in the active group will be given access to the Kick-Nic! app to use for vaping cessation. |
| CONTROL | Active comparator | Behavioral: NCI Quit Vaping websiteParticipants in the control group will be referred to the NCI Quit Vaping website. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kick-Nic! mobile phone applicationThe 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. | Behavioural | ACTIVE |
| NCI Quit Vaping websiteThe 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. | Behavioural | CONTROL |
Primary outcome
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.
2 secondary outcomes
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) at EOT, 3, and 6 month follow up
Time frame: EOT (8 weeks), 3 month follow up, and 6 month follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data that underlie results in a publication may be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suchitra Krishnan-Sarin, Ph.D. principal investigator
Yale University School of Medicine, Dept of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kick-Nic! mobile phone application and NCI Quit Vaping website in people with Nicotine Vaping, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Liss (2034447545, thomas.liss@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.