The purpose of this study is to measure changes in smoking behavior during and following
sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug
Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular
cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a
heating element that vaporizes nicotine. E-cigarettes are likely much safer than
conventional cigarettes, but they may not be entirely safe. We are testing the effects of
one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the
tobacco industry nor any ecigarette manufacturer provides support of any kind to this
study. There is no requirement to quit smoking in this study, nor is there any
requirement to use e-cigarettes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03453385.
Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes
(NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a
battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants
will be recruited nationally, but a subset (N=120) will be recruited locally to allow for
biomarker collection . Our two-fold purpose is to 1) characterize naturalistic uptake of
e-cigarettes, and 2) assess impact of e-cigarette uptake on smoking behavior. All smokers
will be asked to provide smoking diary data, captured electronically, daily for 4 weeks.
More substantive phone assessment will track smoking and related behaviors at baseline
(Day 0) and +10, +17, and +24 days (weekly during initial 3 weeks, following brief lag
for delays in product mailing), and at +1, +3, and +6 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMedical University of South Carolina
