RESUMEN
RATIONALE: Electronic nicotine delivery systems (ENDS) are used by smokers seeking to reduce combustible cigarette (CC) use, but the role of nicotine replacement vs. behavioral and sensory factors is still poorly understood. We hypothesized that providing nicotine from ENDS in addition to nicotine skin patches would promote smoking reduction relative to non-nicotine control ENDS. OBJECTIVES: To assess the effects on smoking behavior of using nicotine vs. placebo ENDS in smokers using nicotine vs. placebo patches. METHODS: Ninety-four daily smokers were enrolled in a study that randomly assigned them to receive ENDS with nicotine vs. without nicotine and skin patches with vs. without nicotine. Smoking reduction and cessation were assessed over an 8-week period by self-report and by expired air carbon monoxide (CO) measurements. The primary outcome was defined as reduction in expired air CO. RESULTS: The use of nicotine in ENDS led to significant reductions in smoking (ENDS nicotine vs. placebo difference in CO change = -9.2 ppm; 90% CI (-1.5 ppm, -16.9 ppm)) and was highly correlated with reductions in self-reported cigarettes per day (r=0.6). The effect of nicotine in nicotine patches was not statistically significant (patch nicotine vs. placebo difference in CO change = -0.1 ppm; 90% CI (-7.8 ppm, 7.6 ppm)). CONCLUSIONS: The presence of nicotine in ENDS was associated with a large reduction in smoking. Additional studies will be needed to determine whether there may be additive effects of nicotine ENDS and nicotine patches on smoking abstinence.