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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416011
• Other study ID #: MCC-18127
• Secondary ID: R01DA037961-01A1
• Status: Completed
• Phase: N/A
• Start date: March 31, 2015
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2896
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study 2: Cost Effectiveness	Cost per incremental cessation will be measured using USD spent on the self help materials provided to the participants in the Generic and eTarget groups at 18 months and 24 months. ***Total cost was calculated for the intervention and not calculated as per participant cost	18 months and 24 months after study recruitment
Primary	Rate of Smoking Abstinence	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.	18 months & 24 months post study enrollment
Secondary	Changes in the Use of Tobacco Products	As a surveillance study, investigators will track changes in the use of both tobacco cigarettes and e-cigarettes over time for ASSESS group only	18 and 24 months post study enrollment

External Links

•   Moffitt Cancer Center Clinical Trials website