Assessment of the abuse liability of three menthol Vuse Solo electronic cigarettes relative to combustible cigarettes and nicotine gum

Mitchell F Stiles, Leanne R Campbell, Tao Jin, Donald W Graff, Reginald V Fant, Jack E Henningfield, Mitchell F Stiles, Leanne R Campbell, Tao Jin, Donald W Graff, Reginald V Fant, Jack E Henningfield

Abstract

Rationale: We 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.

Objective: Using 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.

Methods: Six-hour nicotine uptake and ratings of subjective effects were used to determine abuse liability and pharmacokinetics.

Results: Use 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.

Conclusion: These 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 registration: ClinicalTrials.gov identifier: NCT02664012.

Keywords: Abuse liability; Electronic cigarettes; Menthol; Nicotine pharmacokinetics; Subjective measures.

Conflict of interest statement

Conflict of interest

MF Stiles, LR Campbell, and T Jin are full-time employees of RAI Services Company. RAI Services Company is a wholly owned subsidiary of Reynolds American Inc., which is a wholly owned subsidiary of British American Tobacco plc. DW Graff is a full-time employee of Celerion and provided the original draft of the manuscript. RV Fant and JE Henningfield are full-time employees of PinneyAssociates, which provides consulting services on smoking cessation and tobacco harm minimization (including nicotine replacement therapy and electronic vapor products) to Niconovum, USA, Inc., RJ Reynolds Vapor Company, and RAI Services Company (all subsidiaries of Reynolds American Inc.). JE Henningfield also owns an interest in intellectual property for a novel nicotine medication. Through PinneyAssociates, Fant and Henningfield provide consulting services to pharmaceutical companies on abuse potential assessment, and the regulation of substances with a potential for abuse.

Figures

Fig. 1
Fig. 1
Mean ratings for the urge to smoke question “How strong is your current urge to smoke your usual brand cigarette?”
Fig. 2
Fig. 2
Mean plasma nicotine concentration profiles

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Source: PubMed

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