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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 (C max  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.

clinical pharmacology in drug development

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