Abstract

e-Cigarettes are the most commonly used tobacco product among young adults (YAs). Despite the harms of nicotine exposure among YAs, there are few, if any, empirically tested vaping cessation interventions available. To determine the effectiveness of a text message program for vaping cessation among YAs vs assessment-only control. A parallel, 2-group, double-blind, individually randomized clinical trial was conducted from December 2019 to November 2020 among YA e-cigarette users. Eligible individuals were US residents aged 18 to 24 years who owned a mobile phone with an active text message plan, reported past 30-day e-cigarette use, and were interested in quitting in the next 30 days. Participants were recruited via social media ads, the intervention was delivered via text message, and assessments were completed via website or mobile phone. Follow-up was conducted at 1 and 7 months postrandomization; follow-up data collection began January 2020 and ended in November 2020. The study was prespecified in the trial protocol. All participants received monthly assessments via text message about e-cigarette use. The assessment-only control arm (n = 1284) received no additional intervention. The active intervention arm (n = 1304) also received This is Quitting, a fully automated text message program for vaping cessation that delivers social support and cognitive and behavioral coping skills training. The primary outcome was self-reported 30-day point prevalence abstinence (ppa) at 7 months analyzed under intention-to-treat analysis, which counted nonresponders as vaping. Secondary outcomes were 7-day ppa under intention-to-treat analysis and retention weighted complete case analysis of 30-day and 7-day ppa. Of the 2588 YA e-cigarette users included in the trial, the mean (SD) age was 20.4 (1.7) years, 1253 (48.4%) were male, 2159 (83.4%) were White, 275 (10.6%) were Hispanic, and 493 (19.0%) were a sexual minority. Most participants (n = 2129; 82.3%) vaped within 30 minutes of waking. The 7-month follow-up rate was 76.0% (n = 1967), with no differential attrition. Abstinence rates were 24.1% (95% CI, 21.8%-26.5%) among intervention participants and 18.6% (95% CI, 16.7%-20.8%) among control participants (odds ratio, 1.39; 95% CI, 1.15-1.68; P < .001). No baseline variables moderated the treatment-outcome relationship, including nicotine dependence. Results of this randomized clinical trial demonstrated that a tailored and interactive text message intervention was effective in promoting vaping cessation among YAs. These results establish a benchmark of intervention effectiveness. ClinicalTrials.gov Identifier: NCT04251273.

Highlights

  • MethodsTrial Design The study was a blinded, parallel, 2-group individually randomized clinical trial that compared a tailored, interactive text message intervention with a text message–based assessmentonly control among young adults (YAs) e-cigarette users

  • Data from the US Centers for Disease Control and Prevention show that e-cigarette use among young adults (YAs) increased from 5.2% in 2014 to 9.3% in 2019,1,2 with more than half (56%) of YA ecigarette users reporting that they have never smoked cigarettes

  • Responding to calls for research on e-cigarette cessation interventions,[12,13] this study examined the effectiveness of a text message program for vaping cessation in a randomized clinical trial among YAs

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Summary

Methods

Trial Design The study was a blinded, parallel, 2-group individually randomized clinical trial that compared a tailored, interactive text message intervention with a text message–based assessmentonly control among YA e-cigarette users. The study was prespecified in the trial protocol (Supplement 1).[20] Based on shortterm abstinence rates observed in the pilot trial,[20] the study was powered to detect a treatment difference of 16% (intervention) vs 8% (control) with 80% power at 2-sided α = .05 in a 20% subsample with a randomized sample of 1300 individuals per group (2600 total) under an intention-to-treat (ITT) convention of counting nonresponders as still vaping. Results are reported according to the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline. The study was conducted by Truth Initiative and approved by the Advarra institutional review board

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