Project description:BackgroundReducing the nicotine content in cigarettes could improve public health by reducing smoking and toxicant exposure, but may also have unintended consequences on alcohol use. The primary objective of this study was to examine the effect of reducing the nicotine content in cigarettes on alcohol outcomes. The secondary aim was to examine whether the effects of these cigarettes on alcohol outcomes were mediated by changes in nicotine exposure, smoking behavior, or withdrawal.MethodsBetween June 2013 and July 2014, we conducted a 7-arm, double-blind, randomized clinical trial at 10 U.S.-based sites. Daily smokers not currently interested in quitting (n = 839) were assigned to equally sized groups to smoke for 6 weeks cigarettes containing either normal nicotine content (NNC; 15.8 mg/g, 9 mg tar), moderate nicotine content (5.2 mg/g nicotine, 9 mg tar), or very low nicotine content (VLNC; 0.4 to 2.4 mg/g, 9 to 13 mg tar). This investigation focused on a subsample of current drinkers (n = 403). Each reduced nicotine content cigarette condition was compared to the NNC control condition with respect to trajectories over the 6-week period of average daily alcohol use and occurrence of binge drinking. Moderating variables were considered. Mediation analyses tested potential explanatory processes including changes in nicotine exposure, cigarettes per day, and withdrawal.ResultsOver time, reduced nicotine exposure and smoking rate mediated effects of VLNC cigarette use on reduced alcohol use. There was no evidence of compensatory drinking in response to nicotine reduction or nicotine withdrawal, even among subgroups expected to be at greater risk (e.g., relatively heavier drinkers, highly nicotine-dependent individuals).ConclusionsThe findings suggest that compensatory drinking is unlikely to occur in response to switching to VLNC cigarettes. In contrast, reducing the nicotine content of cigarettes may reduce alcohol use (clinicalTrials.gov number, NCT01681875).

Project description:SignificanceThe US Food and Drug Administration (FDA) is considering a very low nicotine content (VLNC) product standard to substantially reduce nicotine in cigarettes. We examined whether learning about a potential VLNC standard increased smokers' interest in illicit purchases of cigarettes with regular nicotine content if such a standard were adopted.MethodsParticipants were a national convenience sample of 1712 US adult smokers. In an online experiment, we randomly assigned smokers to view information about a new VLNC standard (experimental condition) or no information (control condition). The experimental condition explained that a VLNC standard would remove 95% of the nicotine in cigarettes and would require stores to only sell VLNC cigarettes. Then, the survey assessed smokers' interest in purchasing regular cigarettes from three illicit sources.ResultsSmokers who learned about the VLNC standard were more likely to be very or extremely interested in purchasing regular cigarettes illicitly from a Web site compared to smokers in the control group (24% vs. 16%, p < .001). They were also more interested in illicitly buying cigarettes from a street vendor (19% vs. 13%, p < .001) and a store on an Indian reservation (28% vs. 22%, p < .05), compared to the control. The impact of learning about the VLNC standard on interest in illicit purchases did not differ by smoking frequency or current e-cigarette use.ConclusionsA VLNC standard could increase smokers' interest in illicit purchases of regular nicotine cigarettes. To prevent VLNC-induced illicit trade from undermining public health, FDA should consider proven measures such as track and trace for these products.ImplicationsLittle is known about how a VLNC cigarette standard would affect consumer interest in regular content cigarettes purchased from illicit sources (eg, the Internet). We found that smokers informed about a potential VLNC product standard had greater interest in illicit cigarette purchases, compared to controls. This suggests the importance of proactive measures accompanying a VLNC standard, such as track-and-trace cigarette packaging regulations and communication campaigns, in order to maximize the standard's public health impact.

Project description:INTRODUCTION:Smoking to reduce negative affect has been identified as a key motivational feature of tobacco use. Our recent work suggests that smoking very low nicotine content (VLNC) cigarettes reduces the relationship between negative affect and smoking behavior over a 6-week period. Here, we sought to extend our findings by evaluating whether a gradual or immediate approach to switching to VLNC cigarettes led to a differential reduction in the relationship between affect and smoking behavior over a longer (20-week) period. AIMS AND METHODS:Participants (n = 1250) were adult smokers from 10 US sites randomized to one of three groups: gradual nicotine reduction (15.5, 11.7, 5.2, 2.4, and 0.4 mg of nicotine per gram of tobacco [mg/g]), immediate nicotine reduction (0.4 mg/g), or standard nicotine content cigarettes (15.5 mg/g; control), for 20 weeks. We examined whether the relationship between affect-both negative and positive-and cigarettes per day differed as a function of reduction group. RESULTS:We found that both negative and positive affect were associated with cigarette consumption in the control group, but not in the gradual or immediate reduction groups across the 20 weeks of exposure. CONCLUSIONS:Our results extend previous findings that switching to VLNC cigarettes disrupts the relationship between affect and cigarette consumption by showing that either gradually or immediately reducing cigarette nicotine content achieves this disruption. These findings provide further evidence that switching to VLNC cigarettes reduces nicotine-related reinforcement of cigarette smoking. IMPLICATIONS:These findings support the notion that switching to very low nicotine content cigarettes reduces the association between affect and smoking behavior, and that either a gradual or immediate nicotine reduction approach achieves this reduction. This provides further evidence that switching to very low nicotine content cigarettes weakens reinforcement mechanisms associated with nicotine dependence.

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Another Warning Sign: High Nicotine Content in Electronic Cigarettes Disrupts Mucociliary Clearance, the Essential Defense Mechanism of the Lung.

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