Effectiveness of a Quit Vaping Text Message Program in Promoting Abstinence Among Young Adult E-Cigarette Users: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

Millions of young adults currently vape electronic cigarettes (e-cigarettes), yet little research on vaping cessation interventions exists. Text messaging is a promising, scalable intervention strategy for delivering vaping cessation treatment.

This study evaluates the effectiveness of a text message quit vaping program (<i>This is Quitting</i>) in promoting abstinence from e-cigarettes among young adults; examines changes in self-efficacy, perceived social norms, and social support for quitting as hypothesized mediators of effectiveness; and examines if treatment effectiveness is moderated by gender, race, ethnicity, or sexual minority status.

Overall, 2600 young adult (aged 18-24 years) e-cigarette users in the United States will be recruited via web advertisements to participate in the study. Participants will be randomized to <i>This is Quitting</i> or an assessment-only control condition. The primary outcome measure is 30-day vaping abstinence at 7 months post enrollment.

Study recruitment began on December 18, 2019, and is projected to be completed by spring 2020. The final 7-month follow-up is anticipated to be completed by fall/winter 2020. Because this is the first-ever evaluation of a quit vaping program, we were unable to draw on existing literature to determine the appropriate sample size. Therefore, we examined abstinence rates among an initial pilot sample of 269 participants (<i>This is Quitting</i>: n=148 and control: n=121) who completed the 1-month follow-up to determine the final sample size. The 1-month response rate was 79.2% (213/269), with no difference between arms. Using intention-to-treat analyses that counted nonresponders as still vaping, 30-day abstinence rates were 16.2% (24/148) among those randomized to <i>This is Quitting</i> and 8.3% (10/121) among those randomized to control. A treatment difference of 16% vs 8% is detectable with 80% power at 2-sided alpha=.05 with 260/group (520 total). To detect treatment differences of this magnitude in a 20% subsample (eg, Hispanic or sexual minority young adult e-cigarette users), we will enroll 1300/group (2600 total).

The scientific, clinical, and public health communities are desperate for cessation resources to address vaping among young people. This study is the first-ever comparative effectiveness trial of an intervention to help young people quit vaping. It focuses on evaluating the effectiveness of a theory-grounded, empirically informed text message intervention among young adults. The study is fully powered to examine potentially important subgroup differences among young people who are more vulnerable to e-cigarette use. Although potentially more challenging from a research ethics and pragmatic standpoint, evaluating quit vaping intervention approaches in teens is an important area for future research. Data from this trial will establish a benchmark of effectiveness for other vaping cessation programs and begin to create a body of evidence focused on how best to help young people break free from e-cigarettes.

ClinicalTrials.gov NCT04251273; https://clinicaltrials.gov/ct2/show/NCT04251273

DERR1-10.2196/18327