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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02416011
Recruitment Status : Active, not recruiting
First Posted : April 14, 2015
Last Update Posted : December 9, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: GENERIC Behavioral: eTARGET Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2896 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: GENERIC
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.
Behavioral: eTARGET
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. Study 2: Cost Effectiveness [ Time Frame: Up to 60 months ]
    Cost per incremental cessation and expected life-years saved.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 - Actively 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

Information from the National Library of Medicine

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


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Thomas Brandon, Ph.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02416011    
Other Study ID Numbers: MCC-18127
R01DA037961-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
e-cigarette
nicotine dependence