Trials attempting to provide an understanding of potential long-t

Trials attempting to provide an understanding of potential long-term effects should minimally be 1 month in duration to allow adequate time for behavior change. The primary outcome measures can be considered in three major categories: (a) beneficial impact, (b) acceptability, and (c) adverse consequences. Beneficial impact examines the effects of RNC cigarettes on (a) pattern and neverless rate of tobacco use, (b) toxicant exposure, (c) dependence or trajectory of dependence of smoking experimenters, (d) number of quit attempts, and (e) cessation. Acceptability of the nicotine product involves measurement of (a) dropout rates and reasons for dropping out, (b) extent of compliance with product use, and (c) extent of experience with discomfort (e.g., withdrawal symptoms, craving, negative affect).

Adverse negative consequences would include assessment of (a) compensatory smoking and toxicant exposure and effect, (b) mental, physical, and cognitive effects (e.g., manifestation of psychiatric disorder, fatigue, or cognitive impairment that may affect quality of life or performance), (c) uptake of alcohol, other drugs, or other high risk and unhealthy behaviors, and (d) potentially use of other tobacco products if used conjointly with RNC cigarettes, or product tampering. The primary challenge will be determining how to weigh the beneficial impact with acceptability and potential adverse consequences. Another challenge would be extrapolating results from short-term trials to long-term effects. Assessing the feasibility of RNC cigarettes will be strengthened by convergence of data and modeling public health effects using these data.

Biomarkers as Outcomes Use of biomarkers for assessing exposure levels and the risk for nicotine addiction, cancer, and cardiovascular and pulmonary diseases are essential in examining the effects of RNC cigarettes. These following biomarkers are suggested Drug_discovery based on prior studies showing sensitivity to change in smoking status, differences across tobacco products and/or predictive validity (Carmella et al., 2009; Hatsukami, Benowitz, Rennard, Oncken, & Hecht, 2006; Hecht, Yuan, & Hatsukami, 2010; Yuan et al., 2011, 2012), and targeting different pathophysiological mechanisms associated with disease (Hatsukami et al., 2006), Nicotine exposure: plasma or saliva cotinine, urinary total nicotine equivalents Carbon monoxide Carcinogen biomarkers: 4-(methylnitrosamino)-1-(3-pyridyl)- 1-butanol and its glucuronides, N’-nitrosonor nicotine and its glucuronide, phenanthrene-tetraol, and possibly the mercapturic acid metabolites of acrolein, benzene, and other toxic volatile organic chemicals Cardiovascular disease: exposure biomarkers��oxidants (e.g.

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