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Clinical Trials: Smoking
IRB No. 11-057-6 (Dr. Cheryl Oncken, PI): Nicotine Replacement for Smoking Cessation during Pregnancy
This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler). The primary goals are: to examine the efficacy of the nicotine inhaler compared to a matched placebo for smoking cessation and reduction among pregnant smokers; to compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine) and on birth outcomes (i.e., birth weight and gestational age); to identify factors that determine which women benefit most from the use of nicotine inhaler for smoking cessation during pregnancy; to explore mechanisms by which the nicotine inhaler increases birth weight and gestational age
IRB No. DORN004127 (Dr. Cheryl Oncken, PI): The Menthol Research Study – Manipulating Tobacco Constituents in Female Menthol Smokers
The FDA could reduce the amount of nicotine in cigarettes, or ban menthol from cigarettes. Investigators from Hartford Hospital and the University of Connecticut Health Center are examining the effect of switching to low nicotine or menthol cigarettes on smoking behavior. This study will look at: 1. How reducing nicotine and or menthol in cigarettes can affect the appeal of smoking & quit rates. 2. The amount of toxicant exposure a woman gets from cigarettes. 3. The ways in which cigarette content changes may decrease smoking behavior. 4. How genetic variations in a taste & smell sensitivity may effect tolerability of experimental cigarettes, smoking satisfaction, and smoking behavior. Study Involvement Requires switching to one of the following types of cigarettes for 6 weeks: 1) Low nicotine + NO menthol 2) Low nicotine + menthol 3) Regular nicotine cigarettes + NO menthol 4) Your own brand of nicotine + menthol All participants attend 11 study visits. Participants may receive: *Study cigarettes x 6 weeks *$20 per study visit.
IRB No. 17-045-2 (Dr. Mario Perez, PI): The Airway Inflammatory Profile of E-Cigarette Users
Study objective: The research study is about how the human body, particularly the airways, react to the regular use of e-cigarettes. The purpose is to show that regular use of e-cigarettes can be associated with airway inflammation in the sputum of regular users of e-cig. We intend to study if the regular use of e-cig, in a simliar way to conventional cigarettes, can trigger an inflammatory response in the airways. Hypotheses: 1. subjects who use e-cigarettes have evidence of airway inflammation when compared to healthy non-smoker subjects 2. Subjects who smoke regular tobacco cigarettes have evidence of more airway inflammation than e-cigarette users. 3. Subjects who use e-cigs with flavoring, e.g. chocolate, or regular cigarettes with flavoring (e.g. menthol) will have more airway inflammation than e-cig and regular cigarette users who don't use flavored products, e.g. menthol. Aims: 1. We plan to characterize airway inflammation profile in e-cig users compared to healthy non-smokers 2. We plan to characterize the airway inlfammatory profile of tobacco cigarette smokers compared to e-cig users. 3. We plan to characterize the effect of menthol in e-cigarettes and tobacco cigarettes on the airway inflammatory profile.