Clinical Trial 18631

Cancer Type: Multiple
Interventions:

Study Type: Prevention
Phase of Study: NA
Investigators:


    Overview

    Study Title

    Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E- Cigarettes - Study II

    Summary

    The purpose of this study is to test a series of booklets designed to assist smokers of tobacco cigarettes who are also using e-cigarettes (dual users) in quitting smoking and remaining smoke-free.

    Objective

    Specific Aim 1. To create a minimal smoking-cessation intervention for current dual users of tobacco cigarettes and e-cigarettes (Study I). The intervention will comprise a series of booklets modeled after the Forever Free booklets found to be successful at producing long-term abstinence among the general population of smokers, but adapted to the special needs, circumstances, and risk factors of dual users. Validated methodologies used for adapting the intervention mirror those used in our prior smoking cessation studies, and reflect systematic approaches across three-phases informed by focus group and learner verification methodologies. The intervention will provide assistance for smoking cessation, and also encourage users to taper and eventually terminate their e-cigarette use as per traditional NRT. The end product of Study I will be a series of booklets tentatively titled, "If You Vape: Guide to Quitting Smoking", available both in printed and electronic formats. Specific Aim 2. To evaluate the efficacy of the intervention via a randomized, controlled clinical trial of current dual users (Study II). We will compare the intervention developed under Specific Aim 1 with both an assessment-only condition and a generic self-help condition comprising existing smoking cessation booklets. We hypothesize that recipients of our targeted If You Vape booklets will show higher rates of tobacco abstinence at 6, 12, 18, and 24 months after enrollment, as compared to both comparison conditions. A secondary hypothesis is that the new intervention will produce higher rates of abstinence from e-cigarettes themselves. To identify mechanism of change, we will also test several a priori moderator and mediator variables, including gender, socio-economic status, motivation to quit, nicotine dependence, e-cigarette expectancies, and magnitude of e-cigarette use (frequency, dosage). Specific Aim 3. To calculate and compare the cost-effectiveness of the interventions. Cost- effectiveness data are vital for evaluating the real-world feasibility of an intervention. Small improvements in treatment efficacy may not be justified if they require substantially greater cost. We will compare the interventions not only on outcome efficacy, but on cost-effectiveness with respect to cost per incremental cessation and expected life-years saved. Secondary Aim. To assess longitudinally the dynamic process of tobacco smoking and e- cigarette use among dual users. The large sample enrolled in the RCT will also offer a unique opportunity to assess longitudinally the dual use of tobacco cigarettes and e-cigarettes in a community-based sample. As a surveillance study, we will be able to track changes in the use of both products over time and examine predictors of cessation. We will also be able to examine whether provision of the self-help intervention alters either the patterns of use or cessation predictors. In summary, this project tests whether the high-risk behavior of dual use can be capitalized upon to facilitate smoking cessation and, ultimately, cessation of all nicotine products.

    Inclusion Criteria

  • Current dual users (of tobacco cigarettes and e-cigarettes)
  • Smoking at least one cigarette per week over the past year
  • Using e-cigarettes at least once per week over the past month
  • Not currently enrolled in a face-to-face smoking cessation program
  • Able to speak and read English