Abstract
BackgroundThe U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks.MethodsAdult smokers (N = 200) of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General). Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg). After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a) Usual Nicotine Content (11.6 mg); or (b) Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a) quit smoking with assistance, (b) continue smoking free research cigarettes, or (c) return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 1-hydroxypyrene, oxidative stress biomarkers including 8-isoprostanes, measures of psychiatric symptoms (e.g., depression, anxiety), smoking behavior and dependence (e.g., cigarette consumption, quit attempts), and health effects (e.g., blood pressure, respiratory symptoms).DiscussionResults from this study will inform FDA on the potential effects of regulating the nicotine content of cigarettes and help determine whether smokers with mood and/or anxiety disorders can safely transition to significantly reduced nicotine content cigarettes.Trial registrationTRN: NCT01928758, registered August 21, 2013.
Highlights
The U.S Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content
Results from this study will inform Food and Drug Administration (FDA) on the potential effects of regulating the nicotine content of cigarettes and help determine whether smokers with mood and/or anxiety disorders can safely transition to significantly reduced nicotine content cigarettes
We further hypothesize that there will be no significant increase in cigarette consumption, nicotine-independent biomarkers of tobacco use (e.g., 1-hydroxypyrene, exhaled carbon monoxide (CO)), or adverse health effects in those assigned to the reduced nicotine content (RNC) group vs. those assigned to the usual nicotine content (UNC) group
Summary
The U.S Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. Smokers with a prior mood or anxiety disorder report more severe nicotine withdrawal symptoms during a cessation attempt [14, 15] This suggests that a policy to reduce nicotine content in cigarettes may differentially impact smokers with affective disorders such that they may have more severe nicotine withdrawal symptoms and, as a result, may smoke a greater number of low nicotine cigarettes in order to reduce withdrawal symptoms, thereby increasing their exposure to other toxicants in tobacco smoke, a process termed compensatory smoking [16, 17].
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