Background
Most studies of electronic nicotine delivery systems (ENDS) compare self-selected users vs. non-users. 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 (16mg vs. 24mg), midway through the study allowed a compelling opportunity to examine two ENDS products compared to control group. Primary outcomes, assessed via daily diaries during sampling period and in-person lab 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 24mg and 30% of 16mg using their assigned product for the entire sampling period. Within 24mg ENDs group, 57% made an independent purchase of ENDS, vs. 28% of 16mg, and 14% of control participants (p=.01). Smokers in both ENDS groups significantly reduced their smoking, whereas control participants did not (p=.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 towards 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.