Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes
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|ClinicalTrials.gov Identifier: NCT02416011|
Recruitment Status : Active, not recruiting
First Posted : April 14, 2015
Last Update Posted : December 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: GENERIC Behavioral: eTARGET||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2896 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes|
|Actual Study Start Date :||March 31, 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
No Intervention: Assessment Only (ASSESS)
Participants in this condition will not receive any intervention materials. They will participate solely in the repeated assessments. Including this comparison condition controls for the effect of repeated assessments and allows for the most meaningful evaluation of the efficacy effect size as well as the cost-effectiveness of the eTARGET intervention. This condition will also be the primary source of data for the secondary surveillance aim regarding naturalistic changes in smoking and e-cigarette use over time.
Active Comparator: Generic Self-Help (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.
The initial Stop Smoking for Good brochure, 10 Stop Smoking for Good booklets and 9 supportive My Story pamphlets delivered over 18 months, as used in our previous cessation study.
Other Name: self-help
Experimental: Targeted Self-Help (eTARGET)
Participants in this condition will receive the intervention created as the product of Study I.
The product of Study I is expected to include the initial If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
Other Name: self-help
- Study 2: Rate of Smoking Abstinence [ Time Frame: 24 months post final recruitment ]Rate of smoking abstinence for recipients of 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.
- Study 2: Changes in the Use of Tobacco Products [ Time Frame: Up to 60 months ]As a surveillance study, investigators will track changes in the use of both tobacco cigarettes and e-cigarettes over time and examine predictors of cessation. Investigators will also examine whether provision of the self-help intervention alters either the patterns of use or cessation predictors.
- Study 1: Rate of Survey Responses [ Time Frame: 12 months ]Rate of survey responses required to complete a formative evaluation. The adaptation of the booklets will be based upon adequate findings from a systematic formative evaluation employing current and former dual users.
- Study 2: Cost Effectiveness [ Time Frame: Up to 60 months ]Cost per incremental cessation and expected life-years saved.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416011
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Thomas Brandon, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|