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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. 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.
IRB No. 18-091S-1 (Dr. Erin Mead, PI): Addictive Potential of Little Cigars/Cigarillos in Dual Users: Effect by Flavor and Gender
This study aims to measure the potential for addiction to little cigars and cigarillos (LCCs) compared to cigarettes, determine their substitutability for cigarettes, and whether flavor adds to their addictiveness. We will also explore differences by sex. The focus of the study is on young adults who currently smoke both cigarettes and LCCs. This is a randomized cross-over study with 125 young adult (18-34 years old) dual users (50% women, 50% men) who are not interested in quitting. Participants will be in the study for two weeks. For the first week, they will be randomized to receive either their preferred flavor of LCC or unflavored (plain tobacco) LCCs (of the same brand). They will be asked to use the study-provided LCC in place of their usual LCC as much as they are able to for one week. Then they will cross over and receive the other type of LCC and use that for one week. We will compare measures of dependence and use for flavored vs. unflavored LCCs vs. cigarettes. We will also differences between men and women in their addiction to LCCs.
IRB No. 17-180H-6.2 (Dr. Cheryl Oncken, PI): Electronic Cigarette Use During Pregnancy HHC-2017-0208
An observational, longitudinal, prospective cohort study of 375 women (125 women who smoke conventional cigarettes exclusively during pregnancy, 125 who use e-cigs and 125 dual users). Background: Maternal smoking is one of the most important modifiable causes of poor pregnancy outcomes in the United States causing 16% low birth weight babies, 6% of premature deliveries, and 6% of preterm related deaths. Quitting smoking is the best option to improve maternal and child health, and smoking reduction is also beneficial. However, an increasing number of pregnant smokers may be using electronic cigarettes (e-cigs) as a substitute for or in conjunction with cigarette smoking. Rationale for this study: E-cigs are an emerging public health issue. They may have a net benefit or risk. A need exists to evaluate the impact of e-cigs in vulnerable populations such as pregnant women. The information about the potential risks and benefits is needed to adequately inform pregnant women and health care providers who counsel their patients. Study Design: This is an observational, longitudinal, prospective cohort study. Study Population and Sample Size: Pregnant smokers who exclusively smoke conventional cigarettes, or who use e-cigs. A total of 375 subjects (125 who smoke conventional cigarettes and 125 who use e-cigs, and 125 dual users) will be enrolled across six sites (UCHC, HH, Baystate Medical Center, University of Colorado, Denver Health, and University of East Tennessee). Major Study Interventions: Not a treatment study. Observational only. Providing written smoking cessation education materials and referral to state Quitline if needed. Main Outcome Measures/Analyses: To determine if e-cigarettes use leads to lower exposure to toxicants in pregnant women relative to those pregnant smokers who smoke conventional cigarettes. Hypotheses, aims and objectives: Hypothesis 1: We hypothesize that women who smoke conventional cigarettes will have higher urine NNAL and serum cotinine & benzene levels compared to users of e-cigs (dual users or exclusive users). Aims / objectives 1: To compare the overall toxicant exposure in pregnant women who use e-cigs to women who smoke conventional cigarettes Hypothesis 2: We hypothesize that infants born to women who smoke conventional cigarettes will have higher levels of NNAL, benzene/SPMA and cotinine compared to infants born to users of e-cigs (dual or exclusive users). Aim/Objective 2: To compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes Hypothesis 3: We hypothesize that maternal urine for NNAL will be predictive of birth weight, and that this effect will be mediated by inflammatory processes, measured using markers of inflammation [high sensitivity C-reactive protein (hs CRP) and intercellular adhesion molecule (ICAM-1)]. Any additional effect of benzene/SPMA will be explored. Aim/Objective 3: To explore potential mechanisms by which toxicants could influence birth weight.