J Chromatogr: Biomed Appl 1993: 612 (2): 302309
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We hypothesize that smoking topography measures (i.e., puff volume, puff count, puff flow, and puff duration) will increase for smokers in the RNC cigarette group due to compensatory smoking Primary outcomes The primary outcomes are the following: Non-compliance (use of other nicotine-containing products) by biochemical and self-report measures during the randomization phase Participant drop-out rate during the randomization phase Secondary outcomes Secondary outcomes (measured from baseline to the end of the randomization phase) are: Changes in cigarettes per day Changes in nicotine (measured by plasma cotinine) and tobacco smoke exposure (measured by expired carbon monoxide, tobacco-specific N -nitrosamines) biomarkers Changes in measures of oxidative stress including glutathione (oxidized:reduced ratio) and 8-isoprostanes Changes in nicotine dependence and withdrawal symptoms Changes in stress (in subgroup), measured by the Perceived Stress Questionnaire and salivary cortisol and alpha amylase Changes in smoking topography measures (in subgroup), measured by puff volume, puff count, puff flow, puff duration, inter-puff interval Changes in adverse health effects (e.g., high blood pressure, adverse respiratory symptoms) Proportion of participants choosing to make a quit attempt with biochemically verified abstinence Research cigarettes SPECTRUM research cigarettes are available only through the National Institute of Drug Abuse Drug Supply Program (NOT-DA-14-004) and are obtained via an Investigational Tobacco Product (ITP) application
