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

Liu, Jianmin; Wang, Jingzhu; Vansickel, Andrea R.; Edmiston, Jeffery; Graff, Donald W.; Sarkar, Mohamadi

doi:10.1002/cpdd.909

Cited by 7 publications

(3 citation statements)

References 31 publications

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“…On the contrary, the test products complement and may motivate adult smokers who are interested in continuing to use tobacco products to switch away from cigarettes to a less harmful alternative, although not risk free (because they contain nicotine). The evidence indicates this might be possible because, in a previous pharmacokinetic study, the chews test products demonstrated significantly higher nicotine delivery than the 2‐mg Nicorette gum (GlaxoSmithKline, London, England), with similar scores of satisfaction and the willingness to use the product again 5 . Completely switching to oral products like the test products presents a unique harm reduction opportunity for those adult smokers who are unable or unwilling to quit using tobacco products 6‐8 .…”

Section: Dual Use Of Own‐brand Cigarette and Test Products Exclusiv...mentioning

confidence: 97%

“…The evidence indicates this might be possible because, in a previous pharmacokinetic study, the chews test products demonstrated significantly higher nicotine delivery 2) 0 (0.0) 0 (0.0) 0 (0.0) 7 (3.3) than the 2-mg Nicorette gum (GlaxoSmithKline, London, England), with similar scores of satisfaction and the willingness to use the product again. 5 Completely switching to oral products like the test products presents a unique harm reduction opportunity for those adult smokers who are unable or unwilling to quit using tobacco products. [6][7][8] Adult smokeless tobacco users, who are accustomed to using oral tobacco products-particularly dual users of smokeless tobacco and combustible cigarettes-may similarly experience reductions in harm by switching completely to the test products.…”

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confidence: 99%

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A Randomized, Controlled Study to Assess Biomarkers of Exposure in Adult Smokers Switching to Oral Nicotine Products

Edmiston

Liu

Wang

et al. 2022

The Journal of Clinical Pharma

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This open-label, randomized, controlled, in-clinic, 6-parallel-group study evaluated changes in biomarkers of exposure (BoEs) to select harmful and potentially harmful constituents in adult smokers (N = 213) not planning to quit smoking. Adult smokers were randomized to continue smoking (CS), reduce smoking by 50% and dual use oral tobacco-derived nicotine (OTDN) products (VERVE chews/discs), stop smoking and exclusively use discs or chews, or stop using all tobacco products (NT). The primary objective compared 24-hour urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL; a biomarker for the carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) in dual and exclusive use of discs and chews to continue smoking and NT on day 7. NNAL levels on day 7 were significantly lower (P < .05) among dual and exclusive users of discs/chews compared to continue smoking; median percent reductions were ≈30% and ≈73%, respectively. NNAL levels were not significantly different between those who used discs/chews and the NT group. Many of the additional secondary biomarkers of exposure were significantly lower in dual users (10/19) and exclusive users of discs/chews (17/19) compared to the continue smoking group. Overall, reductions in secondary biomarkers of exposure were greater in exclusive users than dual users. The 24-hour urinary nicotine equivalents were significantly lower (P < .05) among exclusive users of discs/chews compared to continue smoking. The discs/chews appeared to be well tolerated. These results demonstrate that while switching completely to discs/chews substantially reduces exposure to select harmful and potentially harmful constituents, dual use with 50% reduction in cigarette consumption also reduces exposure. oral tobacco-derived nicotine products like discs/chews may present a harm reduction opportunity for adult smokers, particularly those not intending to quit smoking.

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Section: Dual Use Of Own‐brand Cigarette and Test Products Exclusiv...mentioning

confidence: 97%

mentioning

confidence: 99%

A Randomized, Controlled Study to Assess Biomarkers of Exposure in Adult Smokers Switching to Oral Nicotine Products

Edmiston

Liu

Wang

et al. 2022

The Journal of Clinical Pharma

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“…Studies with newer ENDS have shown that those products can generate nicotine yields comparable to, and sometimes exceeding, the nicotine yield from one tobacco cigarette (1.76–2.20 mg) 57–59. Industry-funded studies on novel ONPs suggest that those products deliver nicotine as quickly and to a similar extent as existing smokeless products 60 61…”

Section: Addictiveness and Appeal Of Ends Htps And Onpsmentioning

confidence: 99%

Evolution of tobacco products: recent history and future directions

et al. 2022

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Declines in cigarette smoking prevalence in many countries and the consolidation of the tobacco industry have prompted the introduction of other forms of nicotine delivery. These include electronic nicotine delivery systems (ENDS), heated tobacco products (HTPs) and oral nicotine products (ONPs). Evolving over time, some of these products now deliver nicotine at levels comparable to cigarettes and may serve as effective substitutes for smokers. However, certain products, especially ENDS like JUUL, have also appealed to youth and non-smokers, prompting concerns about expanding nicotine use (and potentially nicotine addiction). The tobacco industry could shift away from primarily promoting cigarettes to promoting ENDS, HTPs and/or ONPs, though at this time it continues to heavily promote cigarettes in low and middle-income countries. Differing regulatory regimes may place upward and downward pressures on both cigarettes and these newer products in terms of population use, and may ultimately drive the extent to which cigarettes are or are not displaced by ENDS, HTPs and/or ONPs in the coming decade.

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Assessment of Abuse Liability and Nicotine Pharmacokinetics of glo Heated Tobacco Products in a Randomized, Crossover Study

Kanobe,

Makena,

Prevette

et al. 2024

Eur J Drug Metab Pharmacokinet

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Background and Objective Heated tobacco products (HTPs) are a class of non-combustible, inhaled tobacco products with the potential to reduce the harm associated with cigarette smoking due to reduced cigarette smoke toxicant exposure. Subjective and nicotine pharmacokinetics measures taken over the course of product use provide a framework for abuse liability (AL) assessment of tobacco and nicotine products as well as information on adoption potential for a new tobacco product, which are important aspects for premarket tobacco product authorization by the US Food and Drug Administration. This study aimed to assess the AL of glo HTPs, operated in either Standard or Boost Modes, compared with high- and low-AL comparators (subjects’ usual brand cigarettes and nicotine gum, respectively). Methods Nicotine uptake and pharmacodynamics measures (including subjective and physiological measures) were assessed in a clinical study of 75 healthy adult non-menthol or menthol smokers using an open-label, randomized crossover study design. Comparisons were made between glo HTPs (Standard or Boost Modes) and each of usual brand (UB) cigarettes and nicotine gum to evaluate nicotine exposure and subjective effects measures. Results Nicotine uptake, as reflected in the area under the curve (AUC) at 15 and 240 min after product use (AUC 0-15 and AUC 0-240 , respectively) and maximum nicotine concentration (C max ) were significantly lower for all glo HTPs compared to UB cigarettes, regardless of the glo device mode. AUC 0-15 values for glo HTPs ranged from 41.26 to 75.71 ng × min/mL, versus 158.04 to 165.53 ng × min/mL for UB cigarettes. Similarly, AUC 0-240 values for glo HTPs ranged from 379 to 596 ng × min/mL, compared to 1123.73 and 1283.37 ng × min/mL for UB cigarettes. The C max for glo HTPs ranged from 5.46 to 9.00 ng/mL, whereas UB cigarettes had C max values of 16.29 to 16.76 ng/mL. The time to reach maximum nicotine concentration (T max ) was significantly shorter for glo HTPs (4–5 min) compared to UB cigarettes (6–7 min), except for one variant of glo HTP in Standard Mode. Nicotine gum exhibited a slower nicotine absorption profile, with a T max of 45 min and C max of 4.60 ng/mL. AUC 0-15 and AUC 0-240 values for nicotine gum were 6.18 and 5.22 ng × min/mL, and 647.80 and 687.68 ng × min/mL for non-menthol and menthol groups, respectively. Subjective measures indicated that glo HTPs were rated significantly lower than UB cigarettes in terms of product liking, smoking urge reduction, product effects, and intent to use again, but were comparable to nicotine gum. Conclusion glo HTPs demonstrated lower AL...

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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

Cited by 7 publications

References 31 publications

A Randomized, Controlled Study to Assess Biomarkers of Exposure in Adult Smokers Switching to Oral Nicotine Products

A Randomized, Controlled Study to Assess Biomarkers of Exposure in Adult Smokers Switching to Oral Nicotine Products

Evolution of tobacco products: recent history and future directions

Assessment of Abuse Liability and Nicotine Pharmacokinetics of glo Heated Tobacco Products in a Randomized, Crossover Study

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