NCT02416011

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

Completed NA Results posted Last updated 23 February 2022

What this trial tests

NA trial testing GENERIC in Smoking Cessation in 2,896 participants. Completed in 30 June 2019.

Timeline

31 March 2015

Primary endpoint
30 June 2019

30 June 2019

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	2,896
Start date	31 March 2015
Primary completion	30 June 2019
Estimated completion	30 June 2019
Sites	1 location across United States

Drugs / interventions tested

• GENERIC
• eTARGET

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Smoking Abstinence Primary · 18 months & 24 months post study enrollment

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.

Group	Value	95% CI
ASSESS at 18 Months	33
ASSESS at 24 Months	40
GENERIC at 18 Months	37
GENERIC at 24 Months	42
eTARGET at 18 Months	38
eTARGET at 24 Months	42

Changes in the Use of Tobacco Products Secondary · 18 and 24 months post study enrollment

As a surveillance study, investigators will track changes in the use of both tobacco cigarettes and e-cigarettes over time for ASSESS group only

Group	Value	95% CI
Asses Cigarette Use at 18 Months	33
ASSESS Cigarette Use at 24 Months	40
ASSES Vaping at 18 Months	27
ASSESS Vaping at 24 Months	32

Study 2: Cost Effectiveness Secondary · 18 months and 24 months after study recruitment

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

Group	Value	95% CI
ASSESS Group at 18 Months	0
ASSESS Group at 24 Months	0
GENERIC Group at 18 Months	1535
GENERIC Group at 24 Months	2369
eTARGET Group at 18 Months	1000
eTarget Group at 24 Months	2253

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Print-based self-help interventions for smoking cessation.
   Livingstone-Banks J, Ordóñez-Mena JM, Hartmann-Boyce J. · · 2019 · cited 46× · PMID 30623970 · DOI 10.1002/14651858.cd001118.pub4
2. Targeted smoking cessation for dual users of combustible and electronic cigarettes: a randomised controlled trial.
   Martinez U, Simmons VN, Sutton SK, Drobes DJ, et al · · 2021 · cited 43× · PMID 34175001 · DOI 10.1016/s2468-2667(20)30307-8
3. A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.
   Meltzer LR, Simmons VN, Sutton SK, Drobes DJ, et al · · 2017 · cited 25× · PMID 28648969 · DOI 10.1016/j.cct.2017.06.014
4. Vaping characteristics and expectancies are associated with smoking cessation propensity among dual users of combustible and electronic cigarettes.
   Brandon KO, Simmons VN, Meltzer LR, Drobes DJ, et al · · 2019 · cited 17× · PMID 30644627 · DOI 10.1111/add.14551
5. Identifying prospective subpopulations of combustible and electronic cigarette dual users in the United States via finite mixture modeling.
   Sutton SK, Brandon KO, Harrell PT, Martínez Ú, et al · · 2022 · cited 13× · PMID 35491736 · DOI 10.1111/add.15906