Phase 4
Completed N=508
Research and Innovation to Stop E-cigarette/Vaping in Young Adults
Nicotine Dependence · E-Cig Use
Source: ClinicalTrials.gov NCT04974580 ↗
Enrolled (actual)
508
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: 7-day Point Prevalence Vaping Abstinence — 55; 54; 61; 59 Participants — p=0.14
◆ Published Evidence
Emerging
5citations · ~5 / year
Quitline-Based Young Adult Vaping Cessation: A Randomized Clinical Trial Examining NRT and mHealth.
Summary
The aim of this study is to test intervention components to help young adults quit vaping. A 2x2 factorial design will be used where all participants receive quitline-delivered behavioral phone counseling, and components to be tested are a digital intervention (with text and online cessation support) and nicotine replacement therapy (NRT).
The research questions and hypotheses for this study are:
1. Which components and combinations of intervention yield the greatest success rates for exclusive vaping cessation among young adult exclusive e-cigarette users? H1: The complete condition (NRT + digital) will yield significantly higher rates of cessation compared to the control condition (quitline only).
2. Does 8 weeks of nicotine replacement therapy (NRT) improve initial cessation outcomes relative to no NRT.
H2: Providing NRT will yield significantly higher quit rates compared to the No NRT condition.
3. Do tailored text-messages and online support during cessation improve initial cessation outcomes relative to no digital content? Are young adult vapers engaged with and satisfied with digital cessation tools? H3: Digital support will yield significantly higher quit rates compared to no digital support.
H4: Higher engagement in digital content will be associated with higher cessation success rates.
Linked Publications
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Quitline-Based Young Adult Vaping Cessation: A Randomized Clinical Trial Examining NRT and mHealth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence Vaping Abstinence |
55; 54; 61; 59 | 0.14 |
| SECONDARY Vaping Abstinence |
46; 45; 52; 53 | — |
| SECONDARY E-cigarette Dependence - PROMIS-E |
-5.5; -2.6; -6.5; -7.3 | — |
| SECONDARY E-cigarette Dependence - Penn State E-cigarette Dependence Index |
1; 1; 4; 0; 10; 1 | — |
| SECONDARY Changes in E-cigarette Use Frequency |
-7.9; -6.9; -9.3; -5.5 | — |
Eligibility Criteria
Inclusion Criteria
- Current, regular user of nicotine e-cigarettes (20+ days in the last month)
- Exclusive e-cigarette user (no other tobacco in the last 30 days; or no other tobacco in the last 90 days if smoked 100+ cigarettes or cigarillos in lifetime)
- Interest in quitting in the next 30 days
- Ownership of a smartphone device
- Ability to speak and read English
Exclusion Criteria
- Pregnant or breastfeeding
- Individuals with schizophrenia or bipolar disorder who do not report that their condition is currently effectively managed
- Individuals who have experienced a heart attack or stroke in the two weeks prior, or who have been diagnosed with rapid/irregular heartbeat or angina in the six months prior to taking the eligibility screener
- Other household members in study
Data sourced from ClinicalTrials.gov (NCT04974580) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.