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Introduction: The majority of smokers do not intend to quit in the near term, making unmotivated smokers a key group to target in public health efforts. Although it is often assumed that continuing smokers will have stable rates of smoking over time, limited research has addressed this issue, particularly among smokers not seeking treatment. In the current study, the aims were to (1) characterize the trajectory of naturalistic smoking among unmotivated smokers and (2) examine relationships between naturalistic smoking trajectories and other smoking-related variables.Methods: The study sample comprised 579 control-group (ie, untreated) smokers within a parent clinical trial, who completed a total of nine assessments over 1 year.Results: Trajectory modeling identified four smoking trajectory groups: stable (72%), shallow decreasers (20%), steep decreasers (5%), and increasers (3%). Membership in the decreasing groups was associated with higher motivation to quit, greater history of quit attempts, and higher cigarettes per day. Females were more likely to be in the increasing versus stable group.Conclusions: Findings provide needed information on stability and change in cigarette consumption over the course of 1 year among an untreated sample of smokers and identified baseline sociodemographic and smoking-related predictors of smoking trajectory group. Refining understanding of these groups is critical in updating population-based tobacco policy modeling efforts and informing cessation induction efforts that capitalize on naturalistic changes in smoking rate over time.Implications: In the current study, we found that approximately 25% of smokers who endorsed low quit motivation at baseline reduced their cigarette consumption over the course of a year, while 3% increased their cigarette consumption and the majority of smokers (72%) maintained a stable pattern. Refining understanding of smoking trajectories is critical in updating population-based tobacco policy modeling efforts and informing cessation induction efforts that capitalize on naturalistic changes in smoking rate over time. [ABSTRACT FROM AUTHOR]

Introduction: Evidence-based cessation methods including nicotine replacement therapy (NRT), non-NRT medications, quitlines, and behavioral treatments are underutilized by smokers attempting to quit. Although a number of studies have demonstrated a relationship between state-level tobacco policies (eg, taxation, appropriations) and cessation, whether such state-level factors influence likelihood of using an evidence-based treatment is unclear. Accordingly, the aims of the present study were: (1) to describe evidence-based cessation method utilization by state and (2) to examine the effect of state-level factors on cessation method utilization above and beyond individual-level predictors.Methods: Data were utilized from the 2010-2011 Tobacco Use Supplement to the Current Population Survey (TUS-CPS). Participants included 9232 smokers who reported a past-year quit attempt. Data on 11 state-level predictors were collated from national datasets. Analyses were based on: (1) descriptive characterization of quit method usage, (2) logistic regression models to determine state-level factors as predictors of quit method utilization, controlling for individual-level predictors, (3) cluster analyses grouping states with similar state-level factors, and (4) examination of cluster as a predictor of cessation method.Results: Tobacco control appropriations significantly predicted NRT, quitline, and behavioral treatment utilization. Additional state-level factors that demonstrated significant relationships included Medicaid coverage of non-NRT medications and behavioral treatment, tobacco tax rate, smoking prevalence, and percentage of population uninsured. State clustering significantly predicted quit method across all four methods.Conclusions: State-level factors influence the likelihood of residents utilizing evidence-based quit methods. Results are discussed in terms of implications for tobacco policy at the state level.Implications: Results from the present study highlight state tobacco control appropriations as a robust predictor of evidence-based cessation method utilization. Other significant state-level predictors of evidence-based cessation method utilization included Medicaid coverage of non-NRT medications and behavioral treatment, tobacco tax rate, smoking prevalence, and percentage of population uninsured. Moreover, state-level predictors clustered together to significantly predict evidence-based cessation method utilization. Thus, increasing tobacco control appropriations, extending health insurance coverage, maximizing revenue from tobacco taxation and tobacco settlements, and ultimately decreasing smoking prevalence are important targets for individual states to promote utilization of evidence-based cessation methods. [ABSTRACT FROM AUTHOR]

Background: As most smokers initiate smoking during adolescence, assessment of smoking motives that underlie trajectories of dependence is critical for both prevention and cessation efforts. In the current study, we expected participants with higher nicotine dependence would smoke (a) less for positive reinforcement (PR) and (b) more for negative reinforcement (NR) motives. We secondarily assessed the relative contribution of PR to NR motives across levels of dependence. Methods: Data were drawn from a study on cue-elicited craving among occasional versus daily adolescent smokers aged 16–20 years (N = 111). Smoking motives were assessed in relation to 3 commonly used measures of nicotine dependence: (a) Fagerström Test for Nicotine Dependence (FTND), (b) Autonomy over Smoking Scale (AUTOS), and (c) Nicotine Dependence Syndrome Scale (NDSS). Results: Compared to occasional smokers, daily smokers had significantly higher scores on each dependence measure and endorsed more prominent NR smoking motives. Each measure of nicotine dependence was strongly associated with NR motives for smoking, although measures differed in their association with PR motives. As expected, the FTND, AUTOS, and NDSS each significantly predicted smoking motive difference score (PR − NR), such that higher dependence was associated with more prominent NR motives for smoking. Conclusions: Results are consistent with our understanding of dependence and provide further support for 3 common measures of nicotine dependence among early stage smokers. [ABSTRACT FROM PUBLISHER]

Traditionally, drug development has evaluated dose, safety, activity, and comparative benefit in a sequence of phases using trial designs and endpoints specifically devised for each phase. Innovations in drug development seek to consolidate the phases and rapidly expand accrual with "seamless" trial designs. Although consolidation and rapid accrual may yield efficiencies, widespread use of seamless first-in-human (FiH) trials without careful consideration of objectives, statistical analysis plans, or trial oversight raises concerns. A working group formed by the National Cancer Institute convened to consider and discuss opportunities and challenges for such trials as well as encourage responsible use of these designs. We reviewed all abstracts presented at American Society of Clinical Oncology annual meetings from 2010 to 2017 for FiH trials enrolling at least 100 patients. We identified 1786 early-phase trials enrolling 57 559 adult patients. Fifty-one of the trials (2.9%) investigated 50 investigational new drugs, were seamless, and accounted for 14.6% of the total patients. The seamless trials included a median of 3 (range = 1-13) expansion cohorts. The overall risk of clinically significant treatment-related adverse events (grade 3-4) was 49.1% (range = 0.0-100%), and seven studies reported at least one toxic death. Rapid expansion of FiH trials may lead to earlier drug approval and corresponding widespread patient access to active therapeutics. Nevertheless, seamless designs must adhere to established ethical, scientific, and statistical standards. Protocols should include prospectively planned analyses of efficacy in disease- or biomarker-defined cohorts of sufficient rigor to support accelerated approval. [ABSTRACT FROM AUTHOR]

Introduction: Snus uptake is nominal among US smokers. This longitudinal study examines (1) perceptions of snus among US smokers given free snus for 6 weeks and (2) a method for assessment of an alternative tobacco product at the population level.Methods: Adult smokers (n = 543; 69.2% female; Mage = 49.3 years), uninterested in quitting, received free snus for ad libitum use. Based on their snus use during a 6-week sampling period, participants included: (1) never users (18.4%, n = 100); (2) experimenters; that is, used ≥ once, but not during the last week of sampling (33.1%; n = 180); and (3) persistent users; that is, used ≥ once during the final week, and ≥ once during any other week of the sampling period. (48.4%; n = 263).Results: Following the sampling period, those who became persistent users were more likely than experimenters to report that switching to alternative tobacco products would lower their risk for health problems (66.5% vs. 50.0%; p = .006). Persistent users also reported greater negative affect relief and craving reduction (ps < .001) than experimenters. Finally, persistent users were more likely than experimenters to describe snus in favorable terms with respect to ease of use, satisfaction, and liking (ps < .05).Conclusions: Subjective experiences with snus, rather than nicotine dependence, explained experimentation versus persistent use. Even among smokers who became persistent snus users, snus was perceived as a poor substitute for cigarettes. This study design (randomized, yet naturalistic) could be extended to other novel tobacco products, including e-cigarettes, to help understand the role new products may have in the tobacco landscape.Implications: This is the first large scale, US-based naturalistic assessment of smokers' reactions to snus during an extended sampling period. This study is directly in line with FDA goals to better understand predictors of initiation, uptake, and use of other tobacco products such as snus, and serves as model for assessment methods of alternative tobacco products at the population level. Most smokers tried the provided sample of snus (approximately 82%). Subjective experiences with snus, rather than nicotine dependence, explained experimentation versus persistent use. Even among smokers who became persistent snus users, snus was perceived as a poor substitute for cigarettes. [ABSTRACT FROM AUTHOR]