NCT02416011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,896

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 18, 2020

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

4.3 years

First QC Date

April 1, 2015

Results QC Date

June 29, 2020

Last Update Submit

February 21, 2022

Conditions

Smoking Cessation

Keywords

e-cigarettenicotine dependence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in the Use of Tobacco Products

    18 and 24 months post study enrollment

Other Outcomes (1)

  • Study 2: Cost Effectiveness

    18 months and 24 months after study recruitment

Study Arms (3)

Assessment Only (ASSESS)

NO INTERVENTION

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.

Generic Self-Help (GENERIC)

ACTIVE COMPARATOR

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

Targeted Self-Help (eTARGET)

EXPERIMENTAL

Participants in this condition will receive the intervention created as the product of Study I.

Behavioral: eTARGET

Interventions

GENERICBEHAVIORAL

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.

Also known as: self-help
Generic Self-Help (GENERIC)
eTARGETBEHAVIORAL

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.

Also known as: self-help
Targeted Self-Help (eTARGET)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study I - First Phase - No Longer Recruiting
  • Greater than 1 year history of daily smoking
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (2)

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PMID: 39868569DERIVED

  • 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.

    PMID: 34175001DERIVED

MeSH Terms

Conditions

Smoking CessationVapingTobacco Use Disorder

Interventions

Drugs, Generic

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmokingSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

Title
Dr. Thomas Bradon
Organization
Moffitt Cancer Center
Thomas.Brandon@moffitt.org
(813) 745-1750

Study Officials

  • Thomas Brandon, Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 14, 2015

Study Start

March 31, 2015

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 23, 2022

Results First Posted

August 18, 2020

Record last verified: 2022-02

Locations

US(1)