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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: GENERIC; Behavioral: eTARGET

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.

• Study Type: Interventional
• Enrollment (Actual): 2896
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: self-help

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)

Publications and helpful links

General Publications

• 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.

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2015
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: nicotine dependence; e-cigarette
• Other Study ID Numbers: MCC-18127; R01DA037961-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No