RationaleWe previously reported that following a short-term product use period, use of non-menthol Vuse Solo electronic cigarettes (ECs) resulted in product effect-related subjective responses and nicotine uptake between those of combustible cigarettes (high-abuse liability comparator) and nicotine gum (low-abuse liability comparator); the results were generally closer to those of nicotine gum.ObjectiveUsing a similar design to the previous study, we evaluated the abuse liability of three menthol-flavored Vuse Solo ECs with the same nicotine contents (14, 29, and 36 mg) in a group of EC-naïve, menthol cigarette smokers, relative to comparator products.MethodsSix-hour nicotine uptake and ratings of subjective effects were used to determine abuse liability and pharmacokinetics.ResultsUse of menthol Vuse Solo resulted in significantly lower responses to subjective measurements (product liking, intent to use product again, and liking of positive product effects), higher urge to smoke responses, and a lower peak (Cmax) and overall extent (AUC0–360) of nicotine uptake compared to smoking the usual brand menthol cigarette. When compared with use of nicotine gum, subjective responses to use of menthol Vuse ECs were in the same direction as those resulting from smoking cigarettes but were more similar to nicotine gum use in magnitude than they were to cigarettes.ConclusionThese findings are concordant with our previous results and provide evidence that menthol Vuse Solo ECs have abuse liability that is lower than menthol cigarettes and potentially greater than that of nicotine gum.Trial registrationClinicalTrials.gov identifier: NCT02664012Electronic supplementary materialThe online version of this article (10.1007/s00213-018-4904-x) contains supplementary material, which is available to authorized users.

Abuse liability (AL) of electronic nicotine delivery systems (ENDS) is relevant as the category increases in popularity as a potentially less-harmful alternative to cigarette smoking. AL assessments are important to the FDA in determining if a new product is appropriate for the protection of public health. This paper reports the results for Vuse Solo and high and low AL-comparators evaluated in an open-label, randomized crossover confinement AL study. The confinement design was adapted from previous ambulatory studies of Vuse Solo and included product familiarization sessions before each four-hour test session in which subjective measures, nicotine uptake, and physiological endpoints were assessed following a single 10-minute ad libitum product use session. Product liking, intent to use again, suppression of urge to smoke, and nicotine uptake were lower after use of Vuse Solo compared to cigarettes and higher after use of Vuse Solo compared to nicotine gum. No significant differences in blood pressure or heart rate were observed between the products pre- to post-product use. These data reinforce previous research showing that Vuse Solo has an AL profile lower than that of combustible cigarettes but higher than that of nicotine gum and may have sufficient AL for product adoption by current adult smokers.

This paper reports the findings of a randomized nicotine pharmacokinetic (PK) study of a closed electronic nicotine delivery system (ENDS). The study evaluated four flavor variants of Vuse Solo ENDS where subjects used their randomized investigational product (IP) for 10 minutes ad libitum and blood samples were collected for PK assessments that included maximum plasma nicotine concentration (Cmax) and area under the nicotine concentration-vs-time curve up to 60 minutes (AUCnic0–60). Baseline-adjusted mean Cmax ranged from 6.53 to 8.21 ng/mL, and mean AUCnic0–60 ranged from 206.87 to 263.52 ng*min/mL for all ENDS IPs. Results for Cmax and AUCnic0-60 values were consistent among the ENDS IP flavor variants tested and results indicate that flavors did not affect nicotine uptake in human subjects.

Summary As the use of electronic nicotine delivery systems (ENDS) continues to increase, there is a need to evaluate their impact on indoor air quality. This study evaluated the differences in concentrations of volatile and particulate compounds (including formaldehyde, benzene, glycerol, propylene glycol, nicotine, and particulate matter) in secondhand vapor (SHV) after ad libitum subject vaping of cig-a-like ENDS, after-subject smoking of combustible cigarettes (CC), and after-subject non-smoking/non-vaping (blank) in an environmental test chamber. A single-center, open-label, parallel-group study was conducted. Seventy-one generally healthy smokers and vapers were randomized to one of six cohorts: Marlboro Gold Pack, Newport Box, Vuse non-menthol (14 mg nicotine/cartridge and 29 mg nicotine/cartridge), Vuse menthol (29 mg nicotine/cartridge), and market-sample ENDS. Concentrations of most secondhand constituents were similar after e-cigarette vaping and blank sessions. Constituent concentrations in SHV after ENDS use were significantly lower than in secondhand smoke (SHS) from CC, with the exception of glycerol and propylene glycol. Secondhand nicotine concentrations after ENDS use were 88–99% lower than after cigarette smoking. Emission factors between the three Vuse products were also similar with the exception of propylene glycol. Concentrations of some secondhand constituents after ENDS use were compared to existing indoor and occupational air quality guidelines and did not show potential to contribute appreciably to indoor air quality. These findings indicate that SHV from ENDS differs qualitatively and quantitatively from the SHS from CC.

We report the findings from a randomized, parallel study designed to evaluate nicotine pharmacokinetics (PK) following 10 min of ad libitum use of electronic nicotine delivery system (ENDS) in four flavor variants. Subjects were randomized an investigational product (IP) and blood samples were collected for PK assessments during a test session. Primary endpoints were baseline-adjusted values of maximum plasma nicotine concentration (Cmax) and area under the nicotine concentration-vs-time curve up to 60 min (AUCnic0–60). Baseline-adjusted mean Cmax ranged from 6.53 to 8.21 ng/mL, and mean AUCnic0–60 ranged from 206.87 to 263.52 ng min/mL for all ENDS IPs. Results of geometric mean Cmax and AUCnic0–60 values were within 95% confidence intervals (CI) among the ENDS IP flavor variants tested.

Abuse liability (AL) of electronic nicotine delivery systems (ENDS) is relevant as the category increases in popularity as a potentially less-harmful alternative to cigarette smoking. AL assessments are important to the FDA in determining if a new product is appropriate for the protection of public health. This paper reports the results for Vuse Solo (G2 cartridge design) compared to high and low AL-comparators evaluated in an open-label, randomized crossover confinement AL study. The confinement design was adapted from previous ambulatory studies of Vuse Solo (G1 cartridge design) and included product familiarization sessions before each four-hour test session in which subjective measures, nicotine pharmacokinetics (PK), and physiological endpoints were assessed following a single 10-min ad libitum product use session. Product liking, intent to use again, suppression of urge to smoke, and nicotine PK were lower after use of Vuse Solo compared to cigarettes and higher after use of Vuse Solo compared to nicotine gum. No significant differences in blood pressure or heart rate were observed between the products pre- to post-product use. These data reinforce previous research and provide the scientific evidence to support regulatory decisions demonstrating that Vuse Solo has an AL profile lower than that of combustible cigarettes but higher than that of nicotine gum and, therefore, may be a suitable replacement for cigarette smoking for some adult smokers.