Clinical trial NCT02416011: Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes
Official title: Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: e-cigarette
nicotine dependence
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2015-04-14
Enrollment: 2896
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop and 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.

Detailed description: The first two aims of the present proposal are to adapt a validated self-help, smoking-cessation intervention to meet the needs of current dual users, and to test this new intervention in a randomized controlled trial (RCT). A third primary aim is to calculate the cost-effectiveness of the intervention. A secondary aim is to gather longitudinal data regarding the patterns of tobacco and e-cigarette use and the course of cessation of either product among dual users.

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 and pamphlets 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 two-phases informed by individual interviews 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 nicotine replacement therapy (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.

Eligibility criteria: Inclusion Criteria:

* Study I - First Phase - No Longer Recruiting

  * Greater than 1 year history of daily smoking
  * 1 month or more of e-cigarette use
  * Able to speak and read English
  * (1) current dual users (of tobacco cigarettes and e-cigarettes) without interest in quitting smoking; (2) current dual users who have attempted, but not quit smoking; (3) current e-cigarette users who have successfully quit smoking; and (4) former dual users who have quit both products.
* Study I - Second Phase - No Longer Recruiting

  * Current dual users (of tobacco cigarettes and e-cigarettes)
  * Smoking at least one cigarette per day 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
* Study II - No Longer Recruiting

  * 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

Primary outcomes:
measure: Rate of Smoking Abstinence
timeFrame: 18 months & 24 months post study enrollment
Secondary outcomes:
measure: Changes in the Use of Tobacco Products
timeFrame: 18 and 24 months post study enrollment
Other outcomes:
measure: Study 2: Cost Effectiveness
timeFrame: 18 months and 24 months after study recruitment
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Thomas Brandon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez U, Simmons VN, Sutton SK, Drobes DJ, Meltzer LR, Brandon KO, Byrne MM, Harrell PT, Eissenberg T, Bullen CR, Brandon TH. Targeted smoking cessation for dual users of combustible and electronic cigarettes: a randomised controlled trial. Lancet Public Health. 2021 Jul;6(7):e500-e509. doi: 10.1016/S2468-2667(20)30307-8.