Opioid Use and Rate of Nicotine Metabolism Among Pregnant Smokers.

INTRODUCTION: Smokers who use opioids smoke more cigarettes per day (CPD) than non-opioid users, which could be due to the effects of opioids on nicotine metabolism. Moreover, nicotine metabolism increases during pregnancy, potentially making quitting more difficult for pregnant smokers. We examined nicotine metabolism and its association with opioid use (OU) and CPD in pregnant smokers. METHODS: We recruited pregnant women who smoked at least 5 CPD for a clinical trial of smoking cessation. Plasma nicotine metabolite ratio (NMR; trans-3'-hydroxycotinine (3HC)/cotinine)-a biomarker of nicotine metabolism-OU (involving methadone, buprenorphine, fentanyl, oxycodone, or tramadol), and CPD were assessed at baseline. We used linear regression to examine the associations between log-transformed NMR, OU, and CPD, adjusting for race/ethnicity and menthol smoking. RESULTS: Among 129 pregnant smokers, 25 (19%) were opioid users; most were maintained on methadone (n = 14). Compared to non-OU smokers, OU smokers had higher median CPD (10.0 vs. 7.0, p = .0007), serum 3HC (81.0 vs. 42.0 ng/mL, p = .0001), and NMR (0.63 vs. 0.43, p < .0001). In addition, methadone-maintained smokers had a higher median NMR than non-OU smokers (0.66 vs. 0.43, p = .0004). Adjusting for covariates, log-transformed NMR was greater in OU smokers (p = .012), specifically methadone-maintained smokers (p = .024), than non-OU smokers. CONCLUSIONS: Our preliminary results show that OU is associated with a higher NMR in pregnant smokers. A larger study sample is needed to replicate this finding, examine potential mechanisms, and determine its clinical significance. IMPLICATIONS: Among pregnant smokers, we observed that nicotine metabolism was significantly faster among opioid users-the majority of whom were on methadone maintenance-compared to nonusers, which could have implications for smoking cessation. Further studies are needed to replicate this finding, evaluate potential mechanisms, and determine its clinical significance.

Causes of Excess Deaths in Puerto Rico After Hurricane Maria: A Time-Series Estimation.

Objectives. To determine the number and causes of excess deaths in Puerto Rico after Hurricane Maria made landfall on September 20, 2017. Methods. We obtained monthly vital statistics data on all deaths from January 2008 through October 2017. We conducted a time-series analysis to estimate excess mortality in September and October 2017 overall and by age, sex, and cause of death. Results. We estimated a total of 1205 excess deaths (95% confidence interval [CI] = 707, 1702). Excess deaths were slightly higher among men than women (632 and 579 deaths, respectively) and found only among people aged 60 years or older (1038 deaths). Most excess deaths occurred from heart disease (253 deaths), "other" causes (204 deaths), diabetes (195 deaths), Alzheimer's disease (122 deaths), and septicemia (81 deaths). Conclusions. The number of excess deaths was similar to recent government estimates. However, this study is the first to identify the causes of death that were exacerbated by the disaster. Public Health Implications. An accurate estimation of the top causes of excess mortality can help authorities plan resource allocation for the island's recovery and for the prevention of deaths in future disasters.

An Ecological Momentary Assessment of Cigarette and Cigar Dual Use Among African American Young Adults.

Introduction: The dual use of cigarettes and cigars among African American young adults is a significant public health issue. Patterns of and reasons for dual use are difficult to capture using traditional self-report methods. This study used ecological momentary assessment (EMA) to characterize patterns of dual smoking and examine the personal and environmental predictors of cigarette and cigar smoking among African American young adult dual users (ages 18-29) in real-time. Methods: For 14 days, 64 participants smoked ad libitum and were prompted four times daily to record their smoking, craving, emotions, social smoking, and environment via text message on their mobile phones. The odds of single product and dual use were examined using adjusted generalized estimating equations. Results: Participants smoked an average of 7.9 cigarettes and 4.2 cigars per day. Cigarettes and cigars were smoked as frequently during periods of dual use as they were during periods of single product use. Cigarette craving was positively associated with cigarette-only smoking (OR: 1.07), whereas cigar craving was positively associated with cigar-only smoking (OR: 1.43) and dual use (OR: 1.08). Cigars had the greatest odds of dual use when with others (OR: 4.69) and in others' homes (OR: 4.33). Cigarettes had the greatest odds of being smoked while alone (OR: 1.57). Conclusions: EMA was useful for capturing variable smoking patterns and predictors. In this study population, cigarettes and cigars appeared to be smoked additively, and cigars smoked socially. These findings can inform future interventions addressing dual use in this high priority population. Implications: This is the first study to use EMA to examine naturalistic patterns and predictors of multiple tobacco use in real-time. African American young adults smoked cigarettes and cigars during periods of dual use as frequently as during periods of single product use. This suggests that most use was additive (one product smoked in addition to another) and less often as substitution (one product smoked instead of another). Social smoking and craving were strongly associated with cigar smoking in single and dual use periods. This study suggests the need for cessation messaging specifically targeted to reduce dual use in this population.

Beyond blunts: Reasons for cigarette and cigar use among African American young adult dual users.

BACKGROUND: African American young adults are at high risk for dual use of cigarettes and cigars. Limited work has explored and characterized the reasons for use in this population and their relative importance for initiation and current smoking of these products. METHOD: Reasons for cigarette and cigar use were systematically explored and categorized using a mixed methods participatory approach called concept mapping. A series of in-person group sessions were held with 30 African American young adult (ages 18-29) current smokers of both cigarettes and cigars in Prince George's County, MD and Washington, DC. Participants brainstormed, sorted, rated, and interpreted their reasons for initiation and past 30-day use of cigarettes and cigars. A cluster map was generated using multi-dimensional scaling, and t-tests were used to explore differences in ratings by background characteristics. RESULTS: Participants generated 64 reasons for smoking cigarettes and cigars, and categorized these reasons into six groups: emotions, urges, access, product characteristics, lifestyle, and outside pressure. Emotions and urges were the most important motivations for initiation and current smoking of both products. Product characteristics were significantly more important for cigar initiation and smoking than for cigarettes, and outside pressure was more important for current smoking of cigars than cigarettes. Ratings differed by gender, socioeconomic status, and smoking characteristics. CONCLUSIONS: Cigarette and cigar smoking have several overlapping motivations, but key differences were also found, most notably for product characteristics. The FDA's regulation of cigars and cigarettes should focus on addressing key characteristics appealing to young adults to curb dual use.

Association between Florida's smoke-free policy and acute myocardial infarction by race: A time series analysis, 2000-2013.

INTRODUCTION: Racial disparities in acute myocardial infarctions (AMIs) are increasing over time. Previous studies have shown that the implementation of smoke-free policies is associated with reduced AMI rates. The objective of this study was to determine the association between smoke-free policy and AMI hospitalization rates and smoking by race. METHODS: Healthcare Cost and Utilization Project data from Florida from 2000-2013 were analyzed using interrupted time series analysis to determine the relationship between Florida's smoke-free restaurant and workplace laws and AMI among the total adult population (aged ≥18years), by age, race, and gender. Behavioral Risk Factor Surveillance System data from Florida from 2000 to 2010 were analyzed using logistic regression to determine the association between policy and the adult smoking prevalence. RESULTS: After implementation of the smoke-free policy, no statistically significant associations between AMI hospitalization rates or smoking prevalence were detected in the total population. In the subgroup analysis, the policy was associated with declines in AMI hospitalization rates among non-Hispanic white adults aged 18-44years (ß=-0.001 per 10,000, p-value=0.0083). No other relationships with AMI hospitalization rates and smoking prevalence were found in the subgroup analysis. CONCLUSIONS: More comprehensive smoke-free and tobacco control policies are needed to further reduce AMI hospitalization rates, particularly among minority populations. Further research is needed to understand and address how the implementation of smoke-free policies affects secondhand smoke exposure among racial and ethnic minorities.

A Two-Wave Observational Study of Compliance With Youth Access and Tobacco Advertising Provisions of the Cigarettes and Other Tobacco Products Act in India.

INTRODUCTION: The Indian Cigarettes and Other Tobacco Products Act prohibits youths' access to tobacco products at points-of-sale and near educational institutions, requires signage stating these restrictions in these venues, and bans outdoor advertisements. This observational study examined compliance with these provisions, changes in compliance over 1 year, and factors associated with compliance. METHODS: Data were collected in 2012 and 2013 from points-of-sale (n = 555 in 2012, n = 718 in 2013), educational institutions (n = 277 in 2012, n = 276 in 2013), and neighborhoods (n = 104 in 2012, n = 125 in 2013) in 25 urban and rural towns in five states. Compliance across years was compared using chi-square tests. Multilevel regression equations assessed factors associated with compliance at Wave 2 and change in compliance from Wave 1 to Wave 2. RESULTS: Most points-of-sale had no/low compliance, with little change over time (58% to 63%, P = .108). The proportion of educational institutions observing just 1-2 provisions increased (39% to 52%, P = .002). Most neighborhoods complied with the advertisement ban at both waves (91% to 96%, P = .172). In the multilevel analysis, point-of-sale compliance increased in small cities; compliance decreased at points-of-sale and increased at institutions in mid-sized cities. Changes in point-of-sale compliance were due to compliance with access restrictions and signage requirements; changes in educational institution compliance were due to compliance with the sales ban. CONCLUSIONS: Compliance with provisions regarding the sale and display of tobacco products is moderate, while compliance with the advertisement ban remains high in these five Indian states. Greater enforcement will further reduce youths' exposure to tobacco products. IMPLICATIONS: The study adds to the literature on compliance and changes in compliance with policy to prohibit youth access to tobacco products in India, a country that has large geographic disparities in youth smoking prevalence. The findings highlight several important areas on which efforts can focus to improve compliance among points-of-sale, educations institutions, and neighborhoods to limit youths' exposure and access to tobacco products. Rural areas and large cities in particular need more concerted efforts.

The role of theory-driven graphic warning labels in motivation to quit: a qualitative study on perceptions from low-income, urban smokers.

BACKGROUND: Use of communication theories in the development of pictorial health warning labels (graphic warning labels) for cigarette packaging might enhance labels' impact on motivation to quit, but research has been limited, particularly among low socioeconomic status (SES) populations in the U.S. This qualitative study explored perceptions of theory-based graphic warning labels and their role in motivation to quit among low-income smokers. METHODS: A cross-sectional qualitative study was conducted with 25 low-income adult smokers in Baltimore, Maryland, who were purposively sampled from a community-based source population. Semi-structured, in-depth interviews were conducted from January to February 2014. Participants were asked about the motivational impact of 12 labels falling into four content categories: negative depictions of the health effects of smoking to smokers and others, and positive depictions of the benefits of quitting to smokers and others. Data were coded using a combined inductive/deductive approach and analyzed thematically through framework analysis. RESULTS: Labels depicting negative health effects to smokers were identified as most motivational, followed by labels depicting negative health effects to others. Reasons included perceived severity of and susceptibility to the effects, negative emotional reactions (such as fear), and concern for children. Labels about the benefits of quitting were described as motivational because of their hopefulness, characters as role models, and desire to improve family health. Reasons why labels were described as not motivational included lack of impact on perceived severity/susceptibility, low credibility, and fatalistic attitudes regarding the inevitability of disease. CONCLUSIONS: Labels designed to increase risk perceptions from smoking might be significant sources of motivation for low SES smokers. Findings suggest innovative theory-driven approaches for the design of labels, such as using former smokers as role models, contrasting healthy and unhealthy characters, and socially-oriented labels, might motivate low SES smokers to quit.

Shared decision-making for cancer care among racial and ethnic minorities: a systematic review.

To assess decision-making for cancer treatment among racial/ethnic minority patients, we systematically reviewed and synthesized evidence from studies of "shared decision-making," "cancer," and "minority groups," using PubMed, PsycInfo, CINAHL, and EMBASE. We identified significant themes that we compared across studies, refined, and organized into a conceptual model. Five major themes emerged: treatment decision-making, patient factors, family and important others, community, and provider factors. Thematic data overlapped categories, indicating that individuals' preferences for medical decision-making cannot be authentically examined outside the context of family and community. The shared decision-making model should be expanded beyond the traditional patient-physician dyad to include other important stakeholders in the cancer treatment decision process, such as family or community leaders.

Biomarkers of Toxicant Exposure and Inflammation Among Women of Reproductive Age Who Use Electronic or Conventional Cigarettes.

Background: Electronic cigarettes (e-cigarettes) generally have a more favorable toxicant profile than conventional cigarettes; however, limited information exists for women of reproductive age (WRA). Our aim was to compare biomarkers of toxicant exposure, inflammation, and oxidative stress among WRA who self-report exclusive e-cigarette use, exclusive cigarette smoking, or never tobacco use (controls). Methods: Multivariable linear regression models were used to compare the geometric means of urinary biomarkers of toxicant exposure and their metabolites, serum markers of inflammation [highly sensitive C-reactive protein, soluble intercellular adhesion molecule (sICAM), interleukin 6, fibrinogen], and a measurement of oxidative stress [prostaglandin F2a-8-isoprostane (F2PG2a)] among WRA from the Population Assessment of Tobacco and Health survey. Results: E-cigarette users had higher levels of lead, tobacco-specific nitrosamines, nicotine metabolites, and some volatile organic compounds (VOCs) than controls. Except for cadmium and lead, e-cigarette users had lower levels of the analyzed urinary toxicant biomarkers compared with cigarette smokers. Cigarette smokers had higher levels of all the biomarkers of toxicant exposure than controls. There were no significant differences in the levels of markers of inflammation and oxidative stress between e-cigarette users and controls. E-cigarette users and controls had lower levels of sICAM and F2PG2a than cigarette smokers. Conclusion: WRA who use e-cigarettes had lower levels of some of the evaluated urinary biomarkers of toxicant exposure and serum biomarkers of inflammation and oxidative stress than those who smoke cigarettes, but higher lead, nicotine metabolites, and some VOCs than controls, which can increase health risks.

Tobacco Point-of-Sale Influence on U.S. Adult Smokers.

INTRODUCTION: Prior research has shown that tobacco companies target point-of-sale (POS) marketing to low-income communities. This research assessed the association between demographic characteristics and venue type with purchasing tobacco products in response to marketing. METHODS: Using Population Assessment of Tobacco and Health (PATH) Study Wave 1 Adult data, this analysis compared promotion awareness and purchase influence among current smokers. RESULTS: Tobacco promotions were more likely to be noticed at convenience stores, gas stations, or tobacco stores than at other outlets. Smokers who bought their cigarettes at these outlets were more likely to purchase a brand other than their usual brand because of marketing. Smokers below the poverty level had greater odds than others to have noticed tobacco ads and to indicate purchase influence. CONCLUSIONS: Point-of-sale marketing is effective in garnering the attention of low-income populations and influencing their tobacco purchases. Enforcing retailers' adherence to regulations is vital.

E-cigarette palatability in smokers as a function of flavorings, nicotine content and propylthiouracil (PROP) taster phenotype.

BACKGROUND: The popularity of E-cigarettes is due in part to their flavorings. The purpose of this study was to determine the effect on smokers' sensory perceptions and liking of various e-cigarette flavorings, and the degree to which those perceptions are influenced by nicotine level, sex, and PROP bitter taster phenotype. METHODS: We recruited 132 non-treatment-seeking, daily cigarette smokers. In repeated trials in one laboratory session participants vaped the Joyetech eGo-C e-cigarette with each of the following flavorings (in random order): unflavored, tobacco, cherry, chocolate, and menthol. Participants vaped the e-juice first without nicotine and then with high nicotine (18 mg/ml), and provided sensory (bitterness/sourness, irritation, sweetness) and liking ratings. Perceived intensity of 6-n-propylthiouracil (PROP) was used to classify the participants as non-tasters (n = 28), medium-tasters (n = 74), or supertasters (n = 28). Mixed-effects linear models and generalized estimating equations were used to evaluate ratings as a function of flavor interacting with nicotine content, sex and taster phenotype, adjusting for age, race/ethnicity, menthol use, and nicotine dependence. RESULTS: Regardless of nicotine level, cherry (ß = 1.76, p < .001) and chocolate (ß = 0.69, p < .001) were rated as sweeter, but were not better liked, than unflavored e-juice. Menthol elicited the highest liking rating, especially for women (ß = 12.23, p < .05) and supertasters (ß = 20.52, p < .05). Regardless of flavor, high nicotine was rated as more irritating (OR = 1.43, 95% CI = 1.02-2.01) than the no-nicotine e-juice. Irritation (ß = -13.65, p < .001), bitterness/sourness (ß = -11.38, p < .001), and sweetness (ß = 4.79, p < .001) were associated with liking. CONCLUSION: Menthol may enhance e-cigarette palatability for some smokers, which may increase e-cigarette utility in smoking cessation.

Adult E-Cigarettes Use Associated with a Self-Reported Diagnosis of COPD.

The use of electronic cigarettes (e-cigarettes) has increased in the US, but little is known about the effects of these products on lung health. The main purpose of this study was to examine the association between e-cigarette use and a participant's report of being diagnosed with chronic obstructive pulmonary disease (COPD) in a nationally representative sample of adults. Methods: The first wave of the Population Assessment of Tobacco and Health (PATH) survey adult data was used (N = 32,320). Potential confounders between e-cigarette users and non-users were balanced using propensity score matching. Odds ratios (OR) were calculated to examine the association between e-cigarette use and COPD in the propensity-matched sample, the entire sample, different age groups, and in nonsmokers. Replicate weights and balanced repeated replication methods were utilized to account for the complex survey design. Results: Of the 3642 participants who met the criteria for e-cigarette use, 2727 were propensity matched with 2727 non e-cigarette users. In the propensity-matched sample, e-cigarette users were more likely to report being diagnosed with COPD (OR 1.43, 95% confidence interval [CI] 1.12-1.85) than non-e-cigarette users after adjusting for confounders. The result was similar in the entire sample and in the different age subgroups. Among nonsmokers, the odds of reporting a COPD diagnosis were even greater among e-cigarette users (OR 2.94, 95% CI 1.73-4.99) compared to non-e-cigarette users. Conclusion: Our findings demonstrate that e-cigarette use was associated with a reported diagnosis of COPD among adults in the US. Further research is necessary to characterize the nature of this association and on the long-term effects of using e-cigarettes.

E-cigarette use is associated with a self-reported diagnosis of prediabetes in never cigarette smokers: Results from the behavioral risk factor surveillance system survey.

BACKGROUND: The use of e-cigarettes is increasing in the US but there is still a paucity of research on the metabolic effects of e-cigarette use. The goal of this work was to determine the association between e-cigarette use and self-reported prediabetes in adult never cigarette smokers. METHOD: The 2017 cross sectional Behavioral Risk Factor Surveillance System (BRFSS) survey data was used for the analysis. Current e-cigarette users reported daily or someday use of e-cigarettes and former e-cigarette users reported no current use of e-cigarettes. Participants who reported a history of diabetes, gestational prediabetes/ diabetes were excluded. Odds ratios were calculated to determine the association between e-cigarette use and self-reported prediabetes in never cigarette smokers after adjusting for potential confounders. RESULTS: There were a total of 154,404 participants that met the inclusion criteria. Of those participants, there were 143,952 never, 1339 current and 7625 former e-cigarette users. Current e-cigarette users had an increased odds of reporting a diagnosis of prediabetes 1.97 (95% CI 1.25-3.10) compared to never e-cigarette users. After stratifying by gender, men and women had an increased odds ratio of reporting a diagnosis of prediabetes 2.36 (95% CI 1.26-4.40) and 1.88 (95% CI 1.00-3.53) respectively when compared to never e-cigarette users. There was no association between former e-cigarette use and a self-reported diagnosis of prediabetes. CONCLUSION: Our findings show that e-cigarette use may be associated with self-reported prediabetes. Further evaluation is needed in prospective studies.

Association between Regular Electronic Nicotine Product Use and Self-reported Periodontal Disease Status: Population Assessment of Tobacco and Health Survey.

Electronic nicotine product use is increasing in the U.S., but few studies have addressed its effects on oral health. The goal of this work was to determine the association between electronic nicotine product use and periodontal disease. Population Assessment of Tobacco and Health adult survey data from 2013⁻2016 (waves 1, 2 and 3) was used for the analysis. Longitudinal electronic nicotine product users used electronic nicotine products regularly every day or somedays in all three waves. Participants with new cases of gum disease reported no history of gum disease in wave 1 but reported being diagnosed with gum disease in waves 2 or 3. Odds ratios (OR) were calculated to determine the association between electronic nicotine product use and new cases of gum disease after controlling for potential cofounders. Compared to never users, longitudinal electronic nicotine product users had increased odds of being diagnosed with gum disease (OR 1.76, 95% Confidence Interval (CI) 1.12⁻2.76) and bone loss around teeth (OR 1.67, 95% CI 1.06⁻2.63). These odds were higher for participants with a history of marijuana and a history of illicit or non-prescribed drug use. Our findings show that e-cigarettes may be harmful to oral health.

Flavored cigar smoking among African American young adult dual users: An ecological momentary assessment.

BACKGROUND: Flavored cigar sales have increased in recent years in the U.S. African American young adults (AAYAs) have high prevalence of smoking flavored cigars and dual use with cigarettes, but the predictors of use are unclear. We examined the predictors of flavored cigar smoking among AAYA dual users. METHODS: We analyzed data from an Ecological Momentary Assessment (EMA) study that captured near real-time affect, smoking cues, and tobacco smoking from eight text-messaging surveys per day over two weeks. Sixty-three AAYA (ages 18-29) dual users of cigarettes and cigars recorded 1205 cigar smoking moments. Multivariable Generalized Estimating Equations were used to assess the predictors of smoking cigars with flavors and specific flavor types. RESULTS: Half of the participants were women (49.2%) and aged between 18-24 (46.7%). Over the two-weeks, almost all (98.4%) participants smoked flavored cigars, and 64.2% of the cigars smoked were flavored. Alcohol (34.4%) was the most frequently smoked flavor type followed by sweet (23.4%) and mint (5.7%). Feeling stressed (AOR = 1.07) and bored (AOR = 1.10) predicted smoking alcohol flavors. Blunt smoking positively predicted smoking sweet flavors (AOR = 4.79), but negatively predicted smoking alcohol flavors (AOR = 0.40). CONCLUSIONS: Smoking flavored cigars, especially alcohol-flavored cigars, was prevalent among AAYA dual users in this study. This group might use specific flavors for different purposes including smoking blunts and boosting mood. Efforts to reduce cigar use need to tackle these risk factors and the increased marketing and low-cost pricing of cigars. A federal ban of cigar flavors might reduce the appeal of cigar products.

Responses to cigarette health warning labels, harm perceptions and knowledge in a national sample of pregnant and non-pregnant women of reproductive age.

INTRODUCTION: Little is known about the effectiveness of cigarette health warning labels (HWLs) among U.S. pregnant and non-pregnant women of reproductive age. Our intent was to examine HWL responses by pregnancy status and their associations with knowledge and perceived harm. METHODS: We conducted cross-sectional analyses of first (2013-2014) and second (2014-2015) Population Assessment of Tobacco and Health waves. The sample (N = 19,095) was representative of U.S. women of reproductive age (18-45 years). We examined three HWL responses (seeing HWLs, forgoing cigarettes because of HWLs, likely-to-quit because of HWLs), perceived harm from smoking, and knowledge of health effects to fetuses and others. Weighted logistic regression compared HWL responses by pregnancy status and their associations with perceived harm and knowledge, adjusting for demographics and tobacco use. Results were presented as marginal predicted probabilities. RESULTS: Pregnant smokers were less likely than never-pregnant smokers to report likelihood of quitting (57% vs 67%, p = 0.020). Forgoing cigarettes and likely-to-quit due to HWLs-but not seeing HWLs-were positively associated with perceived harm and knowledge. Pregnant smokers were less likely to have knowledge of fetal harm (83%) than ever-pregnant (91%, p = 0.006) and never-pregnant (92%, p = 0.003) smokers. However, pregnant smokers who reported likelihood of quitting were much more likely to have knowledge of fetal harm than those who did not (93% vs. 67%, p = 0.028). CONCLUSIONS: Implementation of HWLs that elicit stronger reactions-such as pictorial HWLs-and increase knowledge of fetal risks is one action to help reduce tobacco use in pregnant and non-pregnant U.S. women of reproductive age.

Randomized Trial of Nicotine Inhaler for Pregnant Smokers.

Background: Smoking during pregnancy is a serious public health problem in need of better treatments. Nicotine replacement treatment (NRT) (patch or gum) has not been shown in randomized placebo-controlled trials to be efficacious for smoking cessation during pregnancy. However, the nicotine inhaler may have advantages over other NRTs as it replicates some of the sensory effects of smoking. Objective: The purpose of the study was examine the efficacy and safety of the nicotine inhaler for smoking cessation during pregnancy. We hypothesized that the nicotine inhaler compared to placebo would increase quit rates and reduce smoking during treatment and at the end of pregnancy, result in a higher birth weight and gestational age in the offspring, and reduce the incidence of preterm birth and low birth weight infants. Study Design: We conducted a randomized, double-blind, placebo-controlled trial of the nicotine inhaler for smoking cessation during pregnancy. Pregnant women who smoked ≥5 cigarettes daily received behavioral counseling and random assignment to a 6-week treatment with nicotine or placebo inhaler, followed by a 6-week taper period. Throughout treatment, we assessed tobacco exposure biomarkers, cessation rates, and adverse events. We also obtained information on birth outcomes. The primary outcome was smoking cessation at 32-34 weeks gestation; secondary outcomes were smoking reduction, birth weight and gestational age, and the incidence of preterm birth or low birth weight infants. We compared treatment groups on these measures using t-tests, Fisher's exact tests, and multivariate linear and logistic regression. Results: Participants in the placebo (n=67) and nicotine (n=70) groups were comparable on baseline characteristics, though women in the placebo group reported a higher motivation to quit (p=0.016). Biochemically-validated smoking cessation rates were similar with nicotine and placebo (after 6 weeks of treatment: 4% (3/70) vs. 3% (2/67), respectively, p< 0.99, and at 32-34 weeks gestation: 10% (7/70) vs. 18% (12/67), respectively, p=0.220). Cigarettes per day (CPD) decreased over time in both groups (p< 0.001), with the nicotine inhaler group having a greater decrease than the placebo group two (p=0.022) and six weeks after the quit date (p=0.042), but not at 32-34 weeks gestation (p=0.108). Serum cotinine levels, birth weight, gestational age and reductions in carbon monoxide did not differ by group. However, the incidence of preterm delivery was higher in the placebo than the nicotine group: 15% (10/67) vs. 4% (3/67), respectively, p=0.030). The incidence of delivering a low birth weight infant was also higher in the placebo than the nicotine group: 15% (10/67) vs. 6% (4/67), respectively, p=0.035, but not after adjusting for preterm delivery p=0.268. Conclusions: Although the nicotine inhaler group did not have a higher quit rate during pregnancy than the placebo group, the outcome of preterm delivery occurred less frequently in the nicotine group.