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

Not Applicable

Completed

Conditions: Smoking Cessation

Interventions: Behavioral: GENERIC
Behavioral: eTARGET

Registration Number: NCT02416011

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2896

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Generic Self-Help (GENERIC)	GENERIC	This will allow us to evaluate our novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general. Such a comparison controls for the possibility that e-cigarette users are sufficiently primed to quit smoking and that even a generic, non-targeted intervention would be effective. This possibility will be directly tested by comparing this condition against both the ASSESS and eTARGET conditions in terms of clinical outcomes and cost-effectiveness.
Targeted Self-Help (eTARGET)	eTARGET	Participants in this condition will receive the intervention created as the product of Study I.

Primary Outcome Measures

Name	Time	Method
Rate of Smoking Abstinence	18 months & 24 months post study enrollment	Percentage rate of smoking abstinence for participants who received If You Vape booklets, compared to: A) participants in an assessment-only condition; B) participants in a generic self-help condition comprising existing smoking cessation booklets.

Secondary Outcome Measures

Name	Time	Method
Changes in the Use of Tobacco Products	18 and 24 months post study enrollment	As a surveillance study, investigators will track changes in the use of both tobacco cigarettes and e-cigarettes over time for ASSESS group only