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Randomized Controlled Trial
. 2017 Dec;26(12):1795-1803.
doi: 10.1158/1055-9965.EPI-17-0460. Epub 2017 Nov 10.

A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects

Matthew J Carpenter  1   2   3 , Bryan W Heckman  4   3 , Amy E Wahlquist  2   3 , Theodore L Wagener  5 , Maciej L Goniewicz  6 , Kevin M Gray  4   3 , Brett Froeliger  4   3   7 , K Michael Cummings  4   2   3
Affiliations
Randomized Controlled Trial

A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects

Matthew J Carpenter et al. Cancer Epidemiol Biomarkers Prev. 2017 Dec.

Abstract

Background: Most studies of electronic nicotine delivery systems (ENDS) compare self-selected users versus nonusers. The few randomized studies to date generally support a positive impact on reducing smoking behavior, but these studies are focused on guided ENDS use. This study presents a randomized, naturalistic trial of ENDS with prospective outcomes of uptake and behavioral changes in smoking.Methods: Adult smokers with minimal ENDS history were randomized in a 2:1 ratio to receive product for 3 weeks (n = 46), or not (n = 22). Changes in nicotine delivery (16 vs. 24 mg), midway through the study allowed a compelling opportunity to examine two ENDS products compared with the control group. Primary outcomes, assessed via daily diaries during sampling period and in-person laboratory visits over 4 months, included uptake and usage of ENDS, cessation-related outcomes, and exposure to smoke constituents.Results: All ENDS participants tried product at least once, with 48% of 24 mg and 30% of 16 mg using their assigned product for the entire sampling period. Within the 24 mg ENDs group, 57% made an independent purchase of ENDS, versus 28% of 16 mg, and 14% of control participants (P = 0.01). Smokers in both ENDS groups significantly reduced their smoking, whereas control participants did not (P = 0.03). Cessation behaviors (quit attempts, biologically verified abstinence) numerically but not statistically favored ENDS participants.Conclusions: Results suggest that cigarette smokers are willing to use ENDS with trends toward reduced cigarette smoking and positive changes in cessation-related behaviors.Impact: Randomized, naturalistic trials such as presented herein are needed to understand the population impact of e-cigarettes. Cancer Epidemiol Biomarkers Prev; 26(12); 1795-803. ©2017 AACR.

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Figures

Figure 1
Figure 1. Participant Flow and Study Retention Rates
Figure 2
Figure 2. Incidence and Intensity of E-Cigarette Use During and Beyond Sampling Period
Figure 3
Figure 3. Product Evaluation of Both Cigarettes and ENDS at Visit 4 after Completion of ENDS Sampling)
Figure 4
Figure 4. Rates of Quit Attempts and Cessation through Four Months
See this image and copyright information in PMC

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