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Aims To estimate prevalence of excess intake of paracetamol and investigate seasonal variations therein. Methods Between 2011 and 2016, 14 481 US adults who used paracetamol in the preceding 30 days were sampled from national online panels and completed a detailed online daily diary of paracetamol medication use for 7 days. Respondents were not told that the study concerned paracetamol. Cold/flu season (CFS), identified using Google Trends data, was contrasted to off-season in symptoms, use of paracetamol medications, and consumption exceeding 4 g (the recommended daily maximum). Results Overall, 6.3% [95% confidence interval: 5.9-6.7%] of users exceeded 4 g on at least one day; 3.7% [3.5-3.8%] of usage days exceeded 4 g. Cold/flu symptoms were more likely to be experienced and treated with paracetamol in CFS than off-season. Paracetamol users were more likely to exceed 4 g during CFS (6.5% vs. 5.3%; odds ratio = 1.24, 1.04-1.48); days exceeding 4 g also increased (3.9% vs. 2.8%; odds ratio = 1.37, 1.11-1.69). This was not due to differences in characteristics of individuals using paracetamol in CFS, but primarily to increased use of over-the-counter combination medications designed to treat upper respiratory cold/flu symptoms (33.2% of usage days in CFS vs. 24.8% in off-season; odds ratio = 1.58, 1.46-1.72). When such medications were omitted, there was no statistically significant seasonal variation in exceeding 4 g. Conclusions Paracetamol use and over-dosing increases in CFS, primarily due to increased use of over-the-counter combinations treating upper respiratory cold/flu symptoms. Pharmacists should warn users to follow labelled dosing directions, especially during CFS.

Purpose Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective and very commonly used, but also have side effects. We determined prevalence of NSAID dosing exceeding the daily limit (EDL) and identified related user characteristics and dosing patterns among current ibuprofen users. Methods Online 1-week diary study of 1326 ibuprofen users. NSAIDs were identified by list-based prompting; respondents were not required to know their medications were NSAIDs. Details of hourly use were recorded by respondents daily. Deviations from dosing directions were programmatically determined afterwards. An exit survey obtained information on demographics, medical history, physical and mental health status, attitudes regarding label reading and dosing behavior, and knowledge of product label instructions. Results Most diary users (90%) took over-the-counter ibuprofen during the week; 37% also took non-ibuprofen NSAIDs. Most did not recognize all products taken as NSAIDs. EDL occurred among 11% of users for ibuprofen, 4% of users for other NSAIDs, and on 9.1% of NSAID usage days. EDL was associated with deviations from detailed dosing directions, particularly exceeding the 1-time dose, which occurred more often with medications with 1-pill doses. Personal characteristics associated with EDL included male sex, ongoing pain, poor physical function, daily smoking, having the attitudes of “choosing my own dose” and not starting with the lowest dose, and poor knowledge of the recommended 1-time and 24-hour doses. Conclusions The prevalence of EDL among NSAID users is nontrivial, and it is associated with potentially modifiable factors. Educating consumers about NSAIDs and their dosing directions could reduce excess dosing.

Self-reported daily cigarette counts typically exhibit a preponderance of round numbers, a phenomenon known as heaping or digit preference. Heaping can be a substantial nuisance, as scientific interest lies in the distribution of the underlying true values rather than that of the heaped data. In principle, we can estimate parameters of the underlying distribution from heaped data if we know the conditional distribution of the heaped count given the true count, denoted the heaping mechanism (analogous to the missingness mechanism for missing data). In general, it is not possible to estimate the heaping mechanism robustly from heaped data only. A doubly-coded smoking cessation trial data set that includes daily cigarette count as both a conventional heaped retrospective recall measurement and a precise instantaneous measurement offers the rare opportunity to directly estimate the heaping mechanism. We propose a novel model that describes the conditional probability of the self-reported count as a function of its proximity to the truth and its intrinsic attractiveness, denoted its gravity. We apply variations of the model to the cigarette count data, illuminating the cognitive processes that influence self-reporting behaviors. The principal application of the model will be to enabling the correct analysis of heaped-only data sets. Copyright © 2017 John Wiley & Sons, Ltd.

Background and aims Quitting smoking is the most potent way to reduce the health risks associated with smoking cigarettes, and public health objectives in the United States include dramatic increases in the proportion of smokers making a serious quit attempt each year. The US Centers for Disease Control and Prevention (CDC) has, since 2000, set as its Healthy People 2020 objective to encourage 80% of smokers to make a serious quit attempt per year. This study assessed the trend in quit attempts from 2009 to 2014. Design We examined the percentage of US smokers making a serious quit attempt each year from 2009 to 2014 from the repeating cross-sectional National Health Interview Survey (NHIS). Setting United States. Participants The number of qualifying respondents per year ranged from 5748 in 2010 to 7219 in 2012, with a total of 40 362 respondents included in the analysis. Measurements Respondents were deemed to have made a serious quit attempt if they were either current smokers who reported that they stopped smoking for more than 1 day in the past 12 months because they were trying to quit smoking, or reported being former smokers (smoked 100+ cigarettes life-time, but now not smoking) who quit in the past year. Findings Analyses of trends from 2009 to 2014 showed an overall linear increase in quit attempts [odds ratio (OR) = 1.02, 95% confidence interval (CI) = 1.01–1.04, P = 0.0075], but also a quadratic trend (OR = 1.01, 95% CI = 1.00–1.02, P = 0.0189). Conclusions The proportion of US smokers making a serious quit attempt has increased since 2009, due to an upward trend since 2011. The 2014 serious quit attempt rate was 55.0%. These rates are still below the Healthy People 2020 objective of 80% of smokers making a serious quit attempt per year.

Background and Aims Waterpipe tobacco smoking (WTS) is increasingly prevalent in the United States, especially among young adults. We aimed to (1) adapt items from established dependence measures into a WTS dependence scale for US young adults (the US Waterpipe Dependence Scale), (2) determine the factor structure of the items and (3) assess associations between scale values and behavioral use characteristics known to be linked to dependence. Design Cross-sectional survey. Setting United States. Participants A total of 436 past-year waterpipe tobacco users ages 18–30 years selected at random from a national probability-based panel. Measurements Participants responded to six tobacco dependence items adapted for WTS in US populations. Behavioral use characteristics included factors such as frequency of use and age of initiation. Findings Principal components analysis yielded an unambiguous one-factor solution. Approximately half (52.9%) of past-year waterpipe tobacco users received a score of 0, indicating that none of the six WTS dependence items were endorsed. Approximately one-quarter (25.4%) endorsed one dependence item and 22.7% endorsed two or more items. Higher WTS dependence scores were associated significantly with all five behavioral use characteristics. For example, compared with those who endorsed no dependence items, those who endorsed two or more had an adjusted odds ratio (AOR) of 3.90 [95% confidence interval (CI) = 1.56–9.78] for having had earlier age of initiation and an AOR of 32.75 (95% CI = 9.76–109.86) for more frequent WTS sessions. Conclusions Scores on a six-item waterpipe tobacco smoking dependence scale (the US Waterpipe Dependence Scale) correlate with measures that would be expected to be related to dependence, such as amount used and age of initiation.

Cigarette smoking is a prototypical example of a recurrent event. The pattern of recurrent smoking events may depend on time-varying covariates including mood and environmental variables. Fixed effects and frailty models for recurrent events data assume that smokers have a common association with time-varying covariates. We develop a mixed effects version of a recurrent events model that may be used to describe variation among smokers in how they respond to those covariates, potentially leading to the development of individual-based smoking cessation therapies. Our method extends the modified EM algorithm of Steele (1996) for generalized mixed models to recurrent events data with partially observed time-varying covariates. It is offered as an alternative to the method of Rizopoulos, Verbeke, and Lesaffre (2009) who extended Steele's (1996) algorithm to a joint-model for the recurrent events data and time-varying covariates. Our approach does not require a model for the time-varying covariates, but instead assumes that the time-varying covariates are sampled according to a Poisson point process with known intensity. Our methods are well suited to data collected using Ecological Momentary Assessment (EMA), a method of data collection widely used in the behavioral sciences to collect data on emotional state and recurrent events in the every-day environments of study subjects using electronic devices such as Personal Digital Assistants (PDA) or smart phones.

BACKGROUND: Acetaminophen overuse has been linked to liver injury. PURPOSE: To identify patterns of medication use associated with exceeding the recommended daily maximum dose of 4 g acetaminophen. METHODS: Respondents from a national panel completed a detailed daily medication diary online for 7 days (n = 5649), identifying medications taken from a comprehensive list of over-the-counter (OTC) and prescription (Rx) acetaminophen medications. Respondents were not told the study concerned acetaminophen. Total daily intake was calculated from diary data. Generalized estimating equations assessed the association of medication patterns with exceeding 4 g per day among 3618 respondents who used acetaminophen medications (on 13 852 days) during the diary period. RESULTS: Acetaminophen intake exceeded 4 g on 3.1% of usage days; median intake on those days was 5.5 g. As expected, days when intake exceeded 4 g were almost always (92%) marked by deviations from label directions-exceeding the one-time dose, re-dosing too soon, and concomitant use of multiple acetaminophen medications. Re-dosing too soon was the most frequent deviation, and concomitant use was most strongly tied to exceeding the daily limit. Use of both an Rx and an OTC medication on the same day also increased the odds of exceeding 4 g on days when concomitant use occurred. CONCLUSIONS: Excess dosing of acetaminophen is associated with deviations from label directions and by use of both OTC and Rx medications containing acetaminophen within a single concomitant use day. Copyright © 2015 John Wiley & Sons, Ltd. Language: en

In addition to dichotomous measures of abstinence, smoking studies may use daily cigarette consumption as an outcome variable. These counts hold the promise of more efficient and detailed analyses than dichotomous measures, but present serious quality issues - measurement error and heaping - if obtained by retrospective recall. A doubly-coded dataset with a retrospective recall measurement (timeline followback, TLFB) and a more precise instantaneous measurement (ecological momentary assessment, EMA) serves as a calibration dataset, allowing us to predict EMA given TLFB and baseline factors. We apply this model to multiply impute precise cigarette counts for a randomized, placebo-controlled trial of bupropion with only TLFB measurements available. To account for repeated measurements on a subject, we induce correlation in the imputed counts. Finally, we analyze the imputed data in a longitudinal model that accommodates random subject effects and zero inflation. Both raw and imputed data show a significant drug effect for reducing the odds of non-abstinence and the number of cigarettes smoked among non-abstainers, but the imputed data provide efficiency gains. This method permits the analysis of daily cigarette consumption data previously deemed suspect due to reporting error and is applicable to other self-reported count data sets for which calibration samples are available. Copyright © 2015 John Wiley & Sons, Ltd.

Background Measures of hangover are associated with current and future problematic alcohol use. At present, it is not known whether these associations reflect any direct influence of hangover events on near-term drinking behaviors. The current study aimed to determine whether hangover following a drinking episode influences time to next drink (TTND) and, if so, to determine the direction of this effect and identify any moderating personal or contextual factors. Methods Community-recruited, frequent drinkers oversampled for current smoking (N = 386) carried electronic diaries for 21 days, reporting on drinking behaviors and other experiences. Survival analysis was used to model data from 2,276 drinking episodes, including 463 episodes that were followed by self-reported hangover in morning diary entries. Results When tested as the sole predictor in a survival model, hangover was associated with increased TTND. The median survival time was approximately 6 hours longer after episodes with hangovers compared to those without. In a multivariate model, hangover was only significant in the presence of interaction effects involving craving at the end of the index drinking episode and the occurrence of financial stressors. Additional predictors of TTND in the final multivariate model included age, lifetime alcohol use disorder diagnosis, typical drinking frequency, day of the week, and morning reports of craving, negative affect, and stressors after the index episode. There was no association between morning reports of hangover and contemporaneous diary ratings of likelihood of drinking later the same day. Conclusions The findings suggest that hangover has, at best, a modest or inconsistent influence on the timing of subsequent alcohol use among frequent drinkers.

Author(s): Rubinstein, Mark L; Shiffman, Saul; Moscicki, Anna-Barbara; Rait, Michelle A; Sen, Saunak; Benowitz, Neal L | Abstract: AimsThe purpose of this study was to determine the association between the nicotine metabolic rate and smoking behavior, including addiction, in adolescent smokers.DesignBaseline data from a prospective study of adolescent smoking behaviors and nicotine metabolism.SettingThe setting was an out-patient university hospital in San Francisco.ParticipantsAdolescent smokers (n = 164) aged 13-17 years old.MeasurementsParticipants completed self-report measures of smoking behavior and nicotine dependence (modified Fagerstrom Tolerance Questionnaire: mFTQ). The nicotine metabolite ratio (NMR), a phenotypic marker of the rate of nicotine metabolism, was calculated using the ratio of concentrations of deuterium-labeled 3'-hydroxycotinine to cotinine-d(4) .FindingsParticipants reported smoking a mean of 2.86 cigarettes per day (CPD) [median = 1.78, standard deviation (SD) = 3.35] for 1.37 years (median = 1.0, SD = 1.36). Results from multivariate analyses accounting for age, race/ethnicity, gender and duration of smoking indicated that slower metabolizers smoked more CPD than faster metabolizers (the NMR was inversely related to CPD; P = 0.02). Slower metabolizers also showed greater dependence on the mFTQ (NMR was negatively associated with the mFTQ; P = 0.02).ConclusionsIn adolescence, slower clearance of nicotine may be associated with greater levels of addiction, perhaps mediated by a greater number of cigarettes smoked.

Aims: Smokers who lapse during a cessation attempt are at particularly high risk of relapse, so interventions to help smokers recover from lapses are urgently needed. Two recent studies have suggested continuing to use nicotine patches following a lapse may be a beneficial relapse prevention strategy. However, to date no study that uses approved doses of nicotine patches under real-world conditions has tested this hypothesis. Design & Setting: Clinical trial conducted across eight US study sites. Participants & Measurements: Using data from 509 subjects (240 active; 269 placebo) who lapsed during weeks 3-5 of treatment in a randomized, double blind placebo controlled trial of 21-mg nicotine patches, we examined whether active nicotine patch use improved the chances of recovering abstinence (7-day point-prevalence) at weeks 6 and 10. Findings: Active patch use (versus placebo) increased the likelihood of recovery from a lapse both at 6 weeks (8.3% vs 0.8%; Relative Risk [RR]=11.0, p

Aims This paper aims to identify appropriate criteria for tobacco dependence assessment, evaluate relevant research, and suggest revisions that may be incorporated into DSM-5.

Background: The Hangover Symptoms Scale (HSS) assesses the frequency of 13 symptoms experienced after drinking in the past year. Cross-sectional analyses in college drinkers showed preliminary evidence for the validity of the HSS (Slutske et al., 2003). The current investigation extended this work by examining the construct validity of the HSS in an ecological momentary assessment investigation. Methods: Frequent drinkers (N = 404) carried electronic diaries to track their daily experiences over 3 weeks. Each morning, the diary assessed prior-night drinking behaviors, the presence of current hangover, and intensity of current headache and nausea. Results: Adjusting for sex and body mass, the HSS significantly predicted diary endorsement of hangover (OR = 2.11, 95% CI = 1.78 to 2.49, p Language: en

Aim Using nicotine gum can reduce the amount of weight gained when quitting. Here we examine the relationship between weight gain and use of adequate amounts of gum. To mitigate the confounders associated with correlational analyses, we contrast the effects of active gum and placebo, and analyze outcomes prospectively. Design and setting Randomized double-blind placebo-controlled trial of nicotine gum. Participants were instructed to use nine to 15 pieces of gum/day for the first 2 months of treatment. Participants Participants (n = 103) were randomized to either active (2 mg or 4 mg) or placebo gum. Measurements We examined the effect on weight gain of the interaction between treatment (active versus placebo) and daily gum use [－9 pieces/day (compliant use) versus < 9 pieces/day]. Findings After 30 days of abstinence, smokers treated with active gum had not gained significantly less weight than those on placebo (1.1 kg versus 1.6 kg, P = 0.175). However, a significant compliance・treatment interaction was observed (P = 0.005): active gum users who used －9 pieces/day during the first 14 days of treatment had gained less weight at follow-up (0.6 kg versus 1.6 kg for those who used

Aims This study investigated whether Pavlovian extinction occurs during smoking cessation by determining whether experience abstaining from smoking in the presence of cigarette cues leads to decreased probability of lapsing and whether this effect is mediated by craving. Design Secondary analyses were carried out with data sets from two studies with correlational/observational designs. Setting Data were collected in smokers' natural environments using ecological momentary assessment techniques. Participants Sixty-one and 207 smokers who were attempting cessation participated. Measurements Multi-level path models were used to examine effects of prior experience abstaining in the presence of available cigarettes and while others were smoking on subsequent craving intensity and the probability of lapsing. Control variables included current cigarette availability, current exposure to others smoking, number of prior lapses and time in the study. Findings Both currently available cigarettes [odds ratios (OR) = 36.60, 11.59] and the current presence of other smoking (OR = 5.00, 1.52) were powerful predictors of smoking lapse. Repeated exposure to available cigarettes without smoking was associated with a significantly lower probability of lapse in subsequent episodes (OR = 0.44, 0.52). However, exposure to others smoking was not a reliable predictor, being significant only in the smaller study (OR = 0.30). Craving functioned as a mediator between extinction of available cigarettes and lapsing only in the smaller study and was not a mediator for extinction of others smoking in either study. Conclusions This study showed that exposure to available cigarettes is a large risk factor for lapsing, but that this risk can also be reduced over time by repeated exposures without smoking. Smoking cessation interventions should attempt to reduce cigarette exposure (by training cigarette avoidance) but recognize the potential advantage of unreinforced exposure to available cigarettes.

Aims To determine, in the context of a trial in which counseling did not improve smoking cessation outcomes, whether this was due to a failure of the conceptual theory identifying treatment targets or the action theory specifying interventions. Design Data from a randomized clinical trial of smoking cessation counseling and bupropion SR were submitted to multi-level modeling to test whether counseling influenced real-time reports of cognitions, emotions and behaviors, and whether these targets predicted abstinence. Setting Center for Tobacco Research and Intervention, Madison, WI. Participants A total of 403 adult, daily smokers without contraindications to bupropion SR use. Participants were assigned randomly to receive individual counseling or no counseling and a 9-week course of bupropion SR or placebo pill. Cessation counseling was delivered in eight 10-minute sessions focused on bolstering social support, motivation, problem-solving and coping skills. Measurements Pre- and post-quit ecological momentary assessments of smoking behavior, smoking triggers, active prevention and coping strategies, motivation to quit, difficulty quitting and reactions to initial lapses. Findings Counseling prompted avoidance of access to cigarettes, improved quitting self-efficacy, reduced perceived difficulty of quitting over time and protected against guilt and demoralization following lapses. Results also supported the importance of limiting cigarette access, receiving social support, strong motivation and confidence and easing withdrawal distress during cessation efforts. Quitting self-efficacy and perceived difficulty quitting may partially mediate counseling effects on abstinence. Conclusions Smoking cessation counseling may work by supporting confidence about quitting and reducing perceived difficulty quitting. Counseling did not affect other targets that protect against relapse.

The purposes of this study were to investigate weight loss expectations and goals in a population sample of US adults who planned to make a weight loss attempt, and to examine predictors of those expectations and goals. Participants were 658 overweight and obese adults (55% female, mean age = 47.9 yr, body mass index [BMI] = 31.8 kg/m2) who responded to a telephone survey about weight loss. Respondents reported weight loss expectations (i.e., reductions they realistically expected) and goals (i.e., reductions they ideally desired) for an upcoming “serious and deliberate” weight loss attempt. They also reported the expectations they had, and the reductions they actually achieved, in a previous attempt. Respondents' weight loss expectations for their upcoming attempt (8.0% reduction in initial weight) were significantly more modest than their goals for that attempt (16.8%), and smaller than the losses that they expected (12.0%) and achieved (8.9%) in their most recent past attempt (ps ≤ .003). Women and participants with higher BMI had greater weight loss expectations and goals. After controlling for BMI, age, and gender, previous weight loss was unrelated to expectations, and inversely related to goals, for the upcoming weight loss attempt. Results suggest that overweight and obese individuals can frame realistic weight loss expectations that are more modest than their ideal goals. BMI and gender appear to be more important than previous weight loss experiences in determining expectations among persons planning a weight loss attempt.

Aims Little is known about smoking during the transition to college. The current study examined trajectories of smoking among college freshmen, how trajectories predicted later smoking and the social context of smoking. Design Weekly assessments of daily smoking were collected via the web during the first year of college for a large cohort with a previous history of smoking. Participants and setting A total of 193 college freshmen from a large public university with a previous history of smoking who smoked frequently enough to be included in trajectory analysis.Measurements Measuresincludedweeklyreportsof dailysmoking,familysmoking,perceivedpeerattitudes and smoking, social norms and social smoking environment. Findings Seven trajectories were identified: one of low-level sporadic smoking, one of low-level smoking with a small increase during the year, two classes with a substantial decrease during the year, two classes with relatively small decreases and one class with a substantial increase in smoking. Trajectories of smoking in the freshman year predicted levels of sophomore year smoking, and some social context variables tended to change as smoking increased or decreased for a given trajectory class. Conclusions The transition into college is marked by changes in smoking, with smoking escalating for some students andcontinuingintothesophomoreyear.Shiftsinsocialcontextthatsupportsmokingwereassociatedwithtrajectories of smoking. Despite the focus of developmental models on smoking in early adolescence, the transition into college warrants further investigation as a dynamic period for smoking.

Aim The study aimed to test simultaneously our understanding of the effects of bupropion sustained-release (SR) treatment on putative mediators and our understanding of determinants of post-quit abstinence, including withdrawal distress, cigarette craving, positive affect and subjective reactions to cigarettes smoked during a lapse. The specificity of bupropion SR effects was also tested in exploratory analyses. Design Data from a randomized, placebo-controlled clinical trial of bupropion SR were submitted to mediation analyses. Setting Center for Tobacco Research and Intervention, Madison, WI, USA. Participants A total of 403 adult, daily smokers without contraindications to bupropion SR use. Intervention Participants were assigned randomly to receive a 9-week course of bupropion SR or placebo pill and to receive eight brief individual counseling sessions or no counseling. Measurements Ecological momentary assessment ratings of smoking behavior and putative mediators were collected pre- and post-quit. Findings Results of structural equation and hierarchical linear models did not support the hypothesis that bupropion SR treatment improves short-term abstinence by reducing withdrawal distress or affecting the subjective effects of a lapse cigarette, but provided partial support for mediation by cigarette craving reduction and enhanced positive affect. Bupropion SR effects on point-prevalence abstinence at 1 month post-quit were also mediated partially by enhanced motivation to quit and self-efficacy. Conclusions Results provided some support for models of bupropion SR treatment and relapse and suggested that motivational processes may partially account for bupropion SR efficacy.

Aim Nicotine replacement therapy (NRT) is effective for smoking cessation, but most smokers try to quit without using it. We examined the impact of misperceptions of NRT safety and efficacy on its use. Design and participants A total of 3203 current and former US smokers completed a national mail-out survey of issues and attitudes related to smoking cessation. Findings Two-thirds (66%) of respondents either agreed that ‘Stop-smoking products with nicotine are just as harmful as cigarettes’ or were unsure whether the statement was true. These respondents were less likely to have used NRT in the past [30% versus 49%; odds ratio (OR) = 0.45, 95% confidence interval (CI): 0.39–0.53] and less likely to consider using NRT during future quit attempts (40% versus 53%; OR = 0.60, 95% CI = 0.51–0.71). Additionally, of the respondents who had used nicotine gum in the past 12 months (n = 407), those who had concerns about the safety of NRT reported using fewer pieces of gum per day during treatment (six versus eight pieces/day; P < 0.05), and were less likely to report that they used the gum for greater than 4 weeks (28.5% versus 46.8%; OR = 0.45, 95% CI: 0.27–0.76). A large proportion of the respondents also stated that they did not believe NRT to be efficacious. Conclusions The findings suggest that many smokers are misinformed about the health risks of NRT and that these misperceptions impede not only the adoption of NRT but also compliance during treatment. Misperception of NRT safety is one barrier to effective use of NRT and probably reduces success in quitting.

We examined dietary supplement use for weight loss and perceptions about safety, efficacy, and regulatory oversight of these products. A random digit-dialed telephone survey was conducted in 2005-2006, with a representative sample of 3,500 US adults. The survey assessed the beliefs and practices related to weight control. Outcome measures included the prevalence of dietary supplement use for weight reduction, demographic profile of supplement users, and knowledge about safety, efficacy, and regulation of dietary supplements. Of the adults who made a serious weight-loss attempt (n = 1,444), 33.9% reported ever using a dietary supplement for weight loss. Supplement use was more common among women (44.9%) vs. men (19.8%); those aged 25-34; African Americans (48.7%) or Hispanics (41.6%) vs. whites (31.2%); less educated (38.4% high school degree or less vs. 31.1% some college or more); lower income households (41.8% made$40K vs. 30.3% madeor =$40K); obese (40.7%) vs. overweight (29.1%); those who made more lifetime weight-loss attempts (42.0% madeor =3 vs. 22.1% made3); and those who used more weight-loss methods (48.2% usedor =4 vs. 25.2% used4). Many users and non-users of dietary supplements had misperceptions about these products-many believed they are evaluated for safety and efficacy by the Food and Drug Administration (FDA) before marketing, and that dietary supplements are safer than over-the-counter (OTC) or prescription medications. Use of dietary supplements for weight loss is common. More information about dietary supplements is necessary to correct misperceptions and encourage the use of safe and effective weight-loss methods.

Background: Naltrexone (NTX) has proven to be effective with alcoholics in treatment, with most controlled clinical trials showing beneficial effects on heavy drinking rates. However, little is known about the behavioral mechanisms underlying the effects of NTX on drinking, or about patient characteristics that may moderate NTX's effects on drinking. In this study, ecological momentary assessment (EMA) techniques were used to investigate some of the putative mechanisms of naltrexone's effects on drinking in heavy drinkers who were not seeking treatment for alcohol problems. Polymorphisms in the D4 dopamine receptor (DRD4) gene and the μ-opiate receptor (OPRM1) gene, family history of alcohol problems, age of onset of alcoholism and gender were explored as potential moderators of NTX's effects. Methods: After a one-week placebo lead-in period, heavy drinkers (n = 180), 63% of whom were alcohol-dependent, were randomized to 3 weeks of daily naltrexone (50 mg) or placebo. Throughout the study, participants used EMA on palm-pilot computers to enter, in real time, drink data, urge levels, and subjective effects of alcohol consumption. Results: NTX reduced percentage drinking days in all participants and reduced percent heavy drinking days in DRD4-L individuals; NTX decreased urge levels in participants with younger age of alcoholism onset; NTX increased time between drinks in participants who had more relatives with alcohol problems; and NTX reduced the stimulating effects of alcohol in women. OPRM1 status did not moderate any of NTX's effects. Conclusions: These results confirm earlier findings of NTX's effects on drinking and related subjective effects, and extend them by describing individual difference variables that moderate these effects in the natural environment, using data collected in real time.

Aims To examine the natural history of nicotine withdrawal and individual differences associated with withdrawal duration and severity. Design and Setting Prospective study of withdrawal symptoms among smokers who quit for at least 24 hours. Participants used Ecological Momentary Assessment to monitor symptoms in their natural environment using an Electronic Diary (ED). Participants A total of 214 cigarette smokers (59% female, 92% Caucasian). Intervention All participants received a clinic-based, behavioral, group cessation intervention. Severity and duration of withdrawal was not addressed explicitly in treatment. Measurements Participants were ‘beeped’ by the ED approximately five times/day to complete affect assessments (negative affect, arousal, attention disturbance, restlessness), and daily assessments of sleep disturbance (at waking) and of cognitive performance (each evening) for a week prior to quitting and for up to 21 days after quitting. Withdrawal was considered resolved when withdrawal scores returned to baseline levels for at least 2 consecutive days. Findings All symptoms returned to baseline levels within 10 days of quitting. All variables except arousal and sleep disturbance showed change over time. No robust predictors of individual differences in withdrawal responses emerged. Conclusions The time-course of withdrawal may be shorter than previously reported. The natural history of nicotine withdrawal may have implications for theories of withdrawal and smoking relapse and for smoking cessation treatment.

Current trends indicate that approximately 500 million of the world's existing cigarette smokers will prematurely die of causes that could be prevented by treatment of their addiction to tobacco delivered nicotine. Initial pharmacologically based treatment offerings and approaches have proven the concept that increasing the accessibility and diversity of treatment modalities helps more people quit smoking. These treatments have also shown, however, that the vast majority of smokers continues to find treatment less attractive and less accessible than cigarettes whose appeal is constantly stimulated by new formulations, marketing strategies, and implied claims of reduced risk. There appears to be considerable untapped potential public health benefit, as well as commercial opportunity, for medication developers to reach an increasing fraction of smokers who find current treatments unacceptable, inaccessible, or ineffective. The global opportunities to serve public health via medication development are growing even more rapidly as country after country recognizes the impending economic and health care problems posed by tobacco dependence and are opening their doors to treatment. Three areas of medications development offer particular promise: new forms of nicotine delivery, non-nicotine based medications, and new indications to reach those who are unable or unwilling to completely quit. This article discusses the biobehavioral rationale for medication development, the opportunities, and some of the prominent technical and regulatory challenges.

This article describes a program of research applying Ecological Momentary Assessment (EMA) methods to study relapse to cigarette smoking, with a particular focus on the role of negative affect (NA) and self-efficacy (SE). Day-to-day changes in mood and stress did not predict lapse risk, but more proximal changes in affect were associated with lapses: Many lapses were marked by intense NA and by NA increases in the preceding hours. Individual differences in baseline SE predicted lapse risk, but daily SE was relatively stable during abstinence and did not influence lapse risk. However, lapses resulted in immediate drops in SE, and day-to-day changes in postlapse SE predicted progression to relapse, even after accounting for concurrent smoking. SE showed momentary drops associated with NA, but only among smokers with low baseline SE. Individual differences in baseline SE were only expressed situationally under conditions of NA. The findings highlight the importance of dynamic changes in background conditions and in immediate states as important influences on lapses and relapse and also suggest the importance of considering person by situation interactions.

We describe an ecological momentary assessment (EMA) protocol designed to measure daily life experiences along several psychosocial dimensions (Social Conflict, Task Demand, Decisional Control, Negative Affect, and Arousal) hypothesized to be relevant for cardiovascular disease risk. In a large community sample, these assessments have been administered in conjunction with ambulatory blood pressure (ABP) monitoring and measures of subclinical cardiovascular disease. Several results have emerged that support the promise of this approach. First of all, each of these dimensions of experience appears to be a trigger for cardiovascular activation, with movement on each scale being associated with significant within-person changes in heart rate and blood pressure in the natural environment. Second, there appear to be individual differences in physiological responsiveness to these dimensions of daily experience, with such differences being associated in some cases with laboratory-based assessments of cardiovascular reactivity, as might be expected. Third, EMA ratings are associated in several instances with (between-person) stable individual differences in ABP readings. And finally, we have found that some of the characteristics defined by our EMA ratings are related to measures of subclinical atherosclerosis. Such effects appear to be mediated, in part, by ABP. The advantages of using EMA measures for capturing the effects of psychosocial stressors are highlighted by comparing the predictive validity of these daily life assessments to traditional global self-reports. We conclude by describing future plans for use of this type of assessment protocol for helping us to characterize psychosocial characteristics relevant to cardiovascular disease risk. Personality and social processes during daily living may have an important impact not only on psychological functioning but also on physical health and disease. In this article we review our recent work involving the assessment of daily experience as a means of better understanding the role of psychosocial stress in cardiovascular disease risk. First, we outline the rationale for our interest in daily experience sampling for examining these processes, and we describe the methods we have adopted for this purpose. Next, we review findings from a recent study in which we have used these approaches to examine the role of psychosocial stress on ABP and atherosclerosis in a community-dwelling sample. We compare our approach to more traditional (global self-report and laboratory-observation) methods for examining these relationships in humans, and we discuss potential future directions for use of daily experience sampling in studies of health and behavior.

Aim To assess the efficacy of World Wide Web-based tailored behavioral smoking cessation materials among nicotine patch users. Design Two-group randomized controlled trial. Setting World Wide Web in England and Republic of Ireland. Participants A total of 3971 subjects who purchased a particular brand of nicotine patch and logged-on to use a free web-based behavioral support program. Intervention Web-based tailored behavioral smoking cessation materials or web-based non-tailored materials. Measurements Twenty-eight-day continuous abstinence rates were assessed by internet-based survey at 6-week follow-up and 10-week continuous rates at 12-week follow-up. Findings Using three approaches to the analyses of 6- and 12-week outcomes, participants in the tailored condition reported clinically and statistically significantly higher continuous abstinence rates than participants in the nontailored condition. In our primary analyses using as a denominator all subjects who logged-on to the treatment site at least once, continuous abstinence rates at 6 weeks were 29.0% in the tailored condition versus 23.9% in the nontailored condition (OR = 1.30; P = 0.0006); at 12 weeks continuous abstinence rates were 22.8% versus 18.1%, respectively (OR = 1.34; P = 0.0006). Moreover, satisfaction with the program was significantly higher in the tailored than in the non-tailored condition. Conclusions The results of this study demonstrate a benefit of the web-based tailored behavioral support materials used in conjunction with nicotine replacement therapy. A web-based program that collects relevant information from users and tailors the intervention to their specific needs had significant advantages over a web-based non-tailored cessation program.

Aims To examine the occurrence of persistent use (i.e. use beyond 12 weeks) and concurrent use of nicotine gum with cigarettes among consumers who purchase nicotine gum over-the-counter (OTC). Design Assessment of gum use was conducted in the context of a smoking cessation trial among smokers who purchased Nicorette gum and enrolled in the optional Committed Quitters smoking cessation program. Eligible participants were contacted by telephone 6 weeks and 12 weeks following their self-selected target quit date. Those who reported gum use at 12 weeks were contacted again at week 24. Participants A total of 2655 current smokers who purchased nicotine gum and enrolled in a clinical efficacy trial of the Committed Quitters program. Measurements Detailed information on smoking and gum use, including frequency of use, amount used and reasons for use was obtained at each of the three follow-up assessments. Findings At the 24-week assessment, 6% of participants reported current use of nicotine gum (i.e. persistent use). Those engaging in persistent use averaged 4.7 (SD = 2.5) days of gum use per week and 3.2 (SD = 3.5) pieces of gum per day. Sixty-six per cent of persistent users reported at week 24 that they were not currently smoking, and 67% of persistent users reported they were using gum to establish or maintain abstinence. At the 6-, 12- and 24-week assessments, 14%, 10% and 2% of participants, respectively, reported current use of nicotine gum and current cigarette smoking (i.e. concurrent users). Those concurrent users reported at the 12-week follow-up that they did so an average of 4.4 (SD = 2.1) days per week, that they chewed an average of 2.6 (SD = 3.5) pieces of nicotine gum per day and that they smoked an average of 8.7 (SD = 8.6) cigarettes per day. Conclusion Extended use of nicotine gum is rare. Concurrent use with cigarettes is uncommon. In both cases, the amount of gum use is small. OTC marketing of nicotine gum does not appear to have increased use contrary to labeling nor resulted in patterns of use that should warrant clinical or public health concerns.

We examined the correspondence between laboratory measures of cardiovascular reactivity (CVR) and within-person changes in cardiovascular activity during the challenges of daily life, after adjustment for posture, activity, and other effects. Healthy adults (n = 335) were administered laboratory measures of CVR along with 6 days of ambulatory blood pressure monitoring and electronic diary reports. Compared with low reactors, high laboratory systolic blood pressure (SBP) reactors showed larger increases in SBP during periods of high task demand or low decisional control in daily life. High diastolic blood pressure (DBP) reactors showed larger increases in ambulatory DBP during situations rated as both low control and high demand. This multilevel modeling approach may enhance our ability to detect the correspondence between laboratory and ambulatory measures of CVR, and to identify the circumstances under which it may be most clearly observed.

Aims To assess smoking cessation rates achieved with nicotine gum and patch in simulated over-the-counter (OTC) and actual prescription (Rx) settings. Design Separate open-label studies with gum and patch in OTC and Rx settings. Participants There were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669. Interventions All smokers received active nicotine replacement. In the OTC setting, smokers self-selected doses of nicotine gum (2 or 4 mg Nicorette

This paper reviews theoretical and methodological issues in the measurement of drug craving, with an emphasis on self-report assessment. Despite the important role that craving plays in many research and clinical settings, the way in which the construct is conceptualized and measured rarely receives sufficient attention. Issues pertinent to conceptualizing craving are identified. Because there is no single perfect measure of craving, it is essential that researchers understand the limitations of each measure. Measurement performance concerns that affect the validity of different measures are reviewed. Non-verbal assessment methods are also reviewed. Research factors that may help determine the optimal measures for a given study are highlighted. It is concluded that advances in assessment will proceed only when combined with additional research and a better theoretical understanding of craving.

Aims. To compare a transdermal nicotine patch designed for 24-hour wear with one designed for 16-hour wear for relief of craving and withdrawal, particularly in the morning hours. Design. Smokers were randomly assigned to use one of two common patch regimens: NicoDerm/NiQuitin (24-hour wear, 21 mg nicotine) or Nicotrol/Nicorette (16-hour wear, 15 mg). In a double-dummy design, participants wore two patches during the day, one active, one placebo and one patch while sleeping. Setting. A smoking cessation research clinic. Participants. Two hundred and forty-four smokers who suffered morning cravings. Intervention. Two patch formulations approved and marketed for over-the-counter use in the US- NicoDerm CQ (labeled as 21 mg over 24 hours) and Nicotrol (labeled as 15 mg over 16 hours)-were each used according to its instructions. Smokers also received behavioral counseling. Measurements. For a week of baseline and 2 weeks after quitting, smokers used palm-top computers to assess craving and withdrawal symptoms several times each day. Findings. The 21 mg/24-hour patch yielded consistently better control of craving, not only during the morning hours, but throughout the day, and over the 2-week period of abstinence. Additionally, the 21 mg/24-hour patch yielded greater reductions in anxiety, irritability and restlessness. Smokers using the 21 mg/24-hour dosing regimen also experienced longer abstinence than those using the 15 mg/16-hour patch. Conclusions. These findings demonstrate that 24-hour dosing with a 21 mg patch affords superior relief of craving and withdrawal during the first 2 weeks of abstinence, when symptoms are at their peak, and when relapse is most likely. They confirm the importance of dosing parameters in nicotine replacement products.

Keywords: Craving; ecological momentary assessment; reactivity; recall bias; self-monitoring; smoking cessation

Coping is important for success at smoking cessation, yet little is known about the natural history of coping with urges to smoke during a cessation attempt. In this study, Ecological Momentary Assessment (EMA) methods were used to gather real-time quantitative and qualitative data. For 3 consecutive days during their first 10 days of smoking cessation, 36 participants used tape recorders and palm-top computers to record details of 389 coping episodes, during which they employed 1,047 coping responses. An average of 3.6 coping episodes per day and an average of 2.7 coping responses per episode were reported. Sixty-seven percent of the responses were behavioral and 33% were cognitive. Gender, location of the episode, nicotine dependence, and quitting history were associated with the use of specific strategies. Results indicate that EMA methods and instruments are feasible for measuring coping responses.

We examined the situational antecedents of binge eating episodes and tested for consistency in the antecedents. We evaluated the antecedents of two successive binges via structured interviews with 50 normal-weight nonpurging females who regularly binge. Cluster analysis yielded two categories of binge-promoting situations: solitary negative affect situations and social eating situations. When this empirically derived classification of binge situations was used, the two successively occurring binges did not systematically fall into the same cluster. Consistency on other measures was also modest. Implications of these findings for conceptual models of binge eating and treatment, including the prospect of individually tailored interventions, are discussed.

Because life-style patterns affect many cancer risks, research on health-risk behavior and behavior change is critical to cancer prevention. This report recommends priorities for the next decade of psychosocial research on cancer prevention and detection. The leading priority for future research is to fill gaps in basic knowledge left by the rush to intervention and outcome studies. Such research must be theoretically driven and should aim to develop broad principles applicable to diverse health behaviors. Studies that include relevant process data on various stages of behavior change are considered more desirable than simple outcome studies. Epidemiologic investigations should be expanded to include measures of relevant behaviors, so that their impact on clinical outcomes might be established. More research is needed on lay perception of health risks and on individual and health-system barriers to effective cancer prevention and detection. Studies that address the needs of minority and underprivileged populations are crucial. Funding agencies' narrow categorical mandates impede interdisciplinary research on multiple risk factors and their interactions; these boundaries must be relaxed to promote such approaches. Funding agencies should also consider basic research as a long-term investment towards the development of effective interventions.

This study examines Marlatt's account of the cognitions surrounding relapse episodes. Interviews with 143 ex-smokers who called a relapse prevention hotline provided mixed support for this account. Most subjects, especially those who smoked, stated that they had expected smoking to result in reduced tension. Subjects who were motivated by reduction of craving were unlikely to smoke. Contrary to expectations, all subjects experienced significant drops in self-efficacy as a result of the relapse crisis, regardless of whether or not they smoked. Subjects who did not smoke worried about future crises, while those who did felt guilty about their transgression. Both groups reported feelings of failure, which were related to the absence of coping. These unexpected results, though based on a limited sample, suggest that many subjects' experience of relapses and near-relapses are not well described by current theory.