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Open Access Nicotine Lozenges in the Relief of Behaviorally Provoked Craving

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Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies exploring the efficacy of nicotine mini lozenges to reduce nicotine craving in smokers following behavioral provocation. Methods: Healthy smokers aged ≥18 years enrolled. In Study 1, participants were stratified by number of cigarettes smoked daily; Study 2 enrolled only heavy smokers. After an abstinence period, participants engaged in behavioral provocation to induce nicotine craving before receiving a nicotine mini lozenge (Study 1: 1.5 mg or 4 mg; Study 2: 4 mg) or matching placebo. Craving was assessed using a 100-mm visual analogue scale, and safety was monitored. Results: In Study 1, neither nicotine mini lozenge dose significantly reduced craving in smokers versus placebo. In Study 2, 4-mg nicotine mini lozenges significantly reduced craving scores 5 minutes post-treatment (least-square mean [LSM] change from baseline: –41.8; 95% confidence interval [CI]: –45.8, –37.7) versus placebo (–25.9; 95% CI: –30.0, –21.8; p < .001). Adverse events were infrequent, mild in intensity, and more common with the 4-mg nicotine mini lozenges. Conclusions: Behaviorally provoked nicotine craving can be significantly and safely reduced in heavy/high-dependency smokers with 4-mg nicotine mini lozenges.

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Document Type: Research Article

Affiliations: 1: Los Angeles Clinical Trials, Burbank, CA;, Email: [email protected] 2: Manager, Biostatistics, Research and Development, GlaxoSmithKline Consumer Healthcare, Warren, NJ 3: Principal Clinical Study Manager, Clinical Operations, Portfolio Manager - Respiratory Health, Clinical Development Medical Affairs, Research and Development, GlaxoSmithKline Consumer Healthcare, Warren, NJ 4: Consultant, Medical Affairs, GlaxoSmithKline Consumer Healthcare, Warren, NJ

Publication date: May 1, 2018

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  • The American Journal of Health Behavior seeks to improve the quality of life through multidisciplinary health efforts in fostering a better understanding of the multidimensional nature of both individuals and social systems as they relate to health behaviors.

    The Journal aims to provide a comprehensive understanding of the impact of personal attributes, personality characteristics, behavior patterns, social structure, and processes on health maintenance, health restoration, and health improvement; to disseminate knowledge of holistic, multidisciplinary approaches to designing and implementing effective health programs; and to showcase health behavior analysis skills that have been proven to affect health improvement and recovery.

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