Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability

Stiles, Mitchell F.; Campbell, Leanne R.; Graff, Donald W.; Jones, Bobbette A.; Fant, Reginald V.; Henningfield, Jack E.

doi:10.1007/s00213-017-4665-y

Cited by 52 publications

(81 citation statements)

References 58 publications

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“…The study was reviewed and approved by Chesapeake Institutional Review Board (Columbia, MD) and was conducted in accordance with the ethical standards in the Declaration of Helsinki and applicable sections of the US Code of Federal Regulations and ICH E6 Good Clinical Practices. With few exceptions, the design of the current study was identical to a previous study in which we evaluated non-menthol versions of similar Vuse Solo ECs (Stiles et al 2017). A brief summary of the study methods is provided herein.…”

Section: Methodsmentioning

confidence: 99%

“…For the calculation of area under the effect curve (AUEC), a value of zero was assigned to any time points for which subjects responded as not feeling product effects (positive or negative) on the initial Yes/No question. A more detailed description of the questionnaires is included in the original study publication (Stiles et al 2017). Urge for Product was not administered during UB cigarette use, so the data collected for Urge to Smoke from the cigarette condition was compared to the Urge for Product data from the EC and nicotine gum conditions.…”

Section: Methodsmentioning

confidence: 99%

“…The target number of subjects needed to complete the study was based upon the findings of the previous study evaluating the non-menthol investigational products (Stiles et al 2017). Fifty subjects were required in order to have 80% power to detect an effect size of 0.8 for the subjective measurements (which is equivalent to a mean difference of 0.8 and a standard deviation of 1.0) and at least a 20% absolute difference for the pharmacokinetic (PK) endpoints between each menthol Vuse Solo product and the high- and low-abuse liability comparator products.…”

Section: Methodsmentioning

confidence: 99%

“…Sheri Bowman also provided major support in implementation of the ePRO instruments used in the study; Eckhardt Schmidt oversaw handling of the biological specimens for pharmacokinetic analysis; Angela Slater provided regulatory study support; and Megan Whelen provided valuable input during the writing and editing of the manuscript. Select portions of the content of this paper were presented in a paper previously published by the authors in Psychopharmacology (Stiles et al 2017). …”

Section: Acknowledgementsmentioning

confidence: 99%

“…Menthol has been pointed to as influencing cigarette smoking behavior and the abuse liability of cigarettes (Lawrence et al 2011; Benowitz et al 2011; Ahijevych and Garrett 2004; Henningfield et al 2011). We previously reported that three tobacco-flavored Vuse Solo ECs showed significantly lower abuse liability than combustible cigarettes, and a somewhat higher abuse liability than nicotine gum (Stiles et al 2017). Building upon these findings among smokers of non-menthol, usual brand (UB) cigarettes, we performed the current study using a similar design to examine the same elements of abuse liability for three menthol-flavored Vuse Solo ECs (with smokers of menthol UB cigarettes) containing the same amounts of nicotine as those in the previous study.…”

Section: Introductionmentioning

confidence: 97%

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

et al. 2018

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Acknowledgementsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 97%

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

et al. 2018

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Characterization of the Abuse Potential in Adult Smokers of a Novel Oral Tobacco Product Relative to Combustible Cigarettes and Nicotine Polacrilex Gum

Liu

Wang

Vansickel

et al. 2021

Clinical Pharm in Drug Dev

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Novel noncombustible tobacco products offer adult smokers (ASs) alternatives to combustible cigarettes lower on the continuum of risk; however, the abuse potential of such products has not been well studied. The objective of this study was to evaluate the abuse potential of 2 chewable tobacco‐derived nicotine containing products, VERVE Chews Blue Mint (test 1) and Green Mint (test 2), in ASs compared with own‐brand cigarettes (CIGS) and nicotine polacrilex gum (GUM) using subjective measures and nicotine pharmacokinetics. ASs used the test products during a 5‐day at‐home trial prior to completing an in‐clinic 4‐period randomized crossover study. During the study ASs used test products, CIGS, and GUM once on separate days. Responses to Tobacco/Nicotine Withdrawal and Direct Effects of Product questionnaires were documented, and blood samples were collected to assess nicotine pharmacokinetics during each product use. Nicotine pharmacokinetic parameters (Cmax and AUC) were statistically significantly lower with use of test products compared with CIGS and statistically significantly higher compared with GUM. No appreciable differences were noted between the 2 flavors for any of the end points measured. Reductions in maximum urge to smoke and maximum responses to the question “Is the Product ‘Pleasant’ Right Now?” for the test products were statistically significantly lower than CIGS but comparable to GUM. Similar results were observed for responses to other items in the 2 questionnaires. The test products, under the conditions of this study, carry lower abuse potential than own‐brand cigarettes and similar to nicotine polacrilex gum.

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Human abuse liability assessment of e‐cigarettes: Why, what and how?

Fearon

2022

Drug Testing and Analysis

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Cigarette smoking is the world's leading cause of preventable death and disease. Alternative nicotine products such as e‐cigarettes have tobacco harm reduction potential, by providing smokers with an alternative form of nicotine delivery but with either the reduced presence or absence of the numerous harmful chemicals found in combustible cigarette smoke. One aspect of importance in determining the potential of e‐cigarettes to provide a viable alternative to combustible cigarettes for smokers is their ability to cause dependence, also known as their abuse liability. E‐cigarettes with little or no abuse liability would be unlikely to be used as a substitute for cigarettes, whereas at least some degree of abuse liability is acknowledged as supportive both to aiding cigarette substitution or complete cessation and to preventing relapse. Given this link between abuse liability and substitution efficacy, human studies assessing the abuse liability of e‐cigarettes are important to determine their true harm reduction potential. In this review, the concept of tobacco product abuse liability is discussed, along with the primary elements—pharmacokinetics and pharmacodynamics (subjective effects)—that need to be assessed to determine abuse liability. The review also presents a number of human abuse liability study design considerations and discusses what existing studies in the literature tell us about the abuse liability and harm reduction potential of e‐cigarettes.

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Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability

Cited by 52 publications

References 58 publications

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

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

Characterization of the Abuse Potential in Adult Smokers of a Novel Oral Tobacco Product Relative to Combustible Cigarettes and Nicotine Polacrilex Gum

Human abuse liability assessment of e‐cigarettes: Why, what and how?

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