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Biomedical subjects

S Shiffman

Publications and source records attributed to S Shiffman.

At least 19 recordsLinked to original sources

Characteristics of selectors of nicotine replacement therapy.

OBJECTIVE: To assess differences in demographic and smoking characteristics between smokers who have and have not used nicotine replacement therapy (NRT). DESIGN: Mail survey of US smokers from a national research panel. PARTICIPANTS: Smokers 18 years and over who returned a survey on smoking (n = 9630). The sample was weighted to match the US smoker population on age and sex. MAIN OUTCOME MEASURES: Compared smokers who had/had not used NRT in a quit attempt (ever NRT use or over the counter (OTC) NRT use) on: demographic characteristics, nicotine dependence, history of craving and withdrawal, expected difficulty quitting, and self reported history of smoking related medical illness and psychopathology. RESULTS: NRT users (both ever-users and OTC users) were more likely to be older, male, and better educated. They were also heavier smokers, had experienced more craving and withdrawal upon quitting, and scored higher on measures of dependence. These differences were evident among light smokers, and remained even when smoking rate and time to first cigarette were controlled. CONCLUSION: Smokers who elect to use NRT differ from non-NRT users in ways that predispose them to failure in cessation. Controlling for smoking rate and time to first cigarette does not eliminate these differences, even among light smokers. These differences must be considered when comparing the effectiveness of NRT among samples of smokers who self select their treatment and are likely to bias such outcome comparisons.

Adolescent↗

Smoker and ex-smoker reactions to cigarettes claiming reduced risk.

CONTEXT: The tobacco industry is introducing modified tobacco products claiming to reduce the risk of smoking (potential reduced exposure products, PREPs). If PREPs are perceived as safe, they may deter smokers from quitting and encourage re-initiation by smokers who have quit. OBJECTIVE: To assess smokers' and ex-smokers' perceptions of PREPs and the impact of PREP claims on interest in quitting (among smokers) or in resuming smoking (ex-smokers). DESIGN: A random-digit-dialled survey of US smokers and ex-smokers. We used Eclipse, a modified PREP cigarette, as an exemplar PREP. During the survey, the interviewer read risk reduction claims made for Eclipse by its manufacturer, assessing smokers' interest in quitting before and after the exposure. PARTICIPANTS: 1000 current cigarette smokers and 499 ex-smokers (300 quit within the last two years), over 18 years old. MAIN OUTCOME MEASURES: Perception of risk reduction from Eclipse; interest in using Eclipse; smokers' interest in quitting was assessed using a stage of change approach (pre- and post-exposure to claims). RESULTS: 91% of smokers thought Eclipse was safer than regular cigarettes. 24% believed Eclipse was completely safe. 57.4% of smokers were interested in using Eclipse; interest was greatest among smokers who were contemplating quitting. Exposure to Eclipse's claims was followed by reduced interest in quitting. Among all ex-smokers, interest in Eclipse was 6.2%, but interest was 15.2% among young adults (18-25 years) who had stopped smoking within two years. CONCLUSIONS: There is substantial risk that smokers will overinterpret reduced risk claims made for modified tobacco products. PREPs appeal to smokers who are contemplating quitting and exposure to reduced risk product claims appears to reduce smokers' readiness to quit. PREPs also appealed to young adults who had recently stopped smoking. Thus, reduced risk tobacco product claims can undermine adult cessation and youth prevention, possibly resulting in increased harm even if the products are less toxic.

Adult↗

A meta-analysis of the efficacy of over-the-counter nicotine replacement.

OBJECTIVE: To determine whether over-the-counter (OTC) nicotine replacement therapy (NRT) is pharmacologically efficacious, whether it produces abstinence rates similar to those in prescription settings, and to estimate the long term (that is, greater than six month) abstinence rate with OTC NRT. METHOD: Systematic literature review. DATA SOURCES: Medline, Psych Abstracts, bibliographies, requests of scientists. STUDY SELECTION: Studies comparing OTC NRT versus OTC placebo or studies comparing OTC NRT versus prescription NRT that reported abstinence rates and for which a full study report was available. DATA EXTRACTION: Two of the authors independently reviewed studies and compared results. DATA SYNTHESIS: Meta-analysis was performed by first testing for homogeneity across studies, then combining odds ratios (ORs) weighting by inverse variance and proportions weighting by study sample size. RESULTS: One OTC NRT versus OTC placebo nicotine gum study was excluded due to small sample size and different setting. The four remaining studies were randomised trials of nicotine versus placebo patch with ORs of 2.1-3.2. These outcomes were homogenous and when combined resulted in an OR favouring NRT of 2.5 (95% confidence interval (CI) 1.8 to 3.6). Among the two randomised and two non-randomised trials of OTC NRT versus prescription NRT, one small study had an OR of 0.3, two others had ORs of 1.0 and 1.4, and a fourth study had an OR of 3.6. These results were not homogenous; however, when combined via a random effects model the estimated OR was not less than 1.0--that is, OR 1.4 (95% CI 0.6 to 3.3). The long term (that is, greater than six months) quit rates for OTC NRT was 1% and 6% in two studies and 8-11% in five other studies. These results were not homogenous; however, when combined the estimated OR was 7% (95% CI 4% to 11%). CONCLUSIONS: OTC NRT is pharmacologically efficacious and produces modest quit rates similar to that seen in real world prescription practice.

Drug Prescriptions↗

Persistent use of nicotine replacement therapy: an analysis of actual purchase patterns in a population based sample.

BACKGROUND: In 1996, the US Food and Drug Administration (FDA) approved switching nicotine gum and patch from prescription to over-the-counter (OTC) status. Some expressed concerns that broader availability and lack of physician control might increase persistent use of nicotine replacement therapy (NRT)-that is, use beyond the period specified by the FDA approved label. OBJECTIVE: To estimate the incidence of persistent use of OTC nicotine gum and patch for periods of > 3 months, > or = 6 months, > or = 12 months, and > or 24 months. DESIGN: Analysis of NRT purchase patterns in data from a population based panel of US households that electronically scanned all household purchases between January 1997 and March 2000. SUBJECTS: In a national panel of 40,000 US households, 2690 recorded NRT purchases. RESULTS: Among 805 households that purchased nicotine gum, 2.3% of new purchase incidents led to continuous monthly purchase of gum for > or = 6 months. For nicotine patches (2050 households) the percentage was 0.9%. For both gum and patch, the incidence of persistent purchase dropped below 0.4% by 24 months. Allowing one month gaps within a "continuous" purchase run resulted in increased estimates (for gum: 6.7% for > or = 6 months and 1.0% for > or = 24 months; for patch: 1.7% for > or = 6 months and 0.05% for > or = 24 months). CONCLUSION: Persistent use of nicotine gum and patch is very rare and has not increased with the transition to OTC use, despite removal of physician oversight.

Administration, Cutaneous↗

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy.

The study evaluated the efficacy of the Committed Quitters Program (CQP), a computer-tailored set of printed behavioral support materials offered free to purchasers of NicoDerm CQ patches, as a supplement to the nicotine patch and the standard brief User's Guide (UG) and audiotape. Callers to the CQP enrollment were randomized to either CQP (n=1854) or just the UG (n=1829). Abstinence and use of program materials were assessed by telephone interview at 6 and 12 weeks (the latter falling 2 weeks after patch use was to be discontinued). Considering all respondents, abstinence rates did not differ significantly between the UG and CQP groups. As expected, among those who reported they used their assigned materials (80.1% of the sample) smokers who received CQP demonstrated higher quit rates at both 6 weeks (38.8% v. 30.7%) and 12 weeks (18.2% v. 11.1%), compared to the UG group. Among those who used it, the Committed Quitters Program proved to be an effective behavioral treatment, improving quit rates over nicotine replacement therapy and a brief untailored written guide and audiotape.

Administration, Cutaneous↗

Effect of oral nicotine dosing forms on cigarette withdrawal symptoms and craving: a systematic review.

RATIONALE: Oral nicotine dosing forms such as nicotine gum have been found to be effective in helping smokers to stop. Some, but not all studies have also found that they reduce the severity of withdrawal discomfort. With new oral nicotine products being developed and use of existing products widening, it is important to determine the strength of evidence that these forms of nicotine replacement reduce overall withdrawal discomfort and individual withdrawal symptoms including craving. OBJECTIVES: To assess the strength of evidence that oral nicotine reduces the severity of overall withdrawal discomfort and individual withdrawal symptoms, including craving. METHODS: All published studies reporting effects of nicotine gum, inhaler, lozenge and sublingual tablet on recognised withdrawal symptoms were scanned and those that met a set of quality criteria were included in the review. The key characteristics of these studies were summarised and their findings tabulated. RESULTS: Of 27 studies that reported effects of oral nicotine products on at least one withdrawal symptom, 12 met the quality criteria (eight for nicotine gum, three for inhaler, one for microtab, none for 1 mg lozenge). Because of limitations on the reporting of the studies it was not possible to carry out meta-analyses and good data were available only for the first week of abstinence. Six out of seven studies reporting it found an effect on total withdrawal discomfort, nine out of nine found an effect on irritability, three out of four found an effect on anxiety and the only study that looked at it found an effect on depressed mood. Seven of 11 studies that looked at it found an effect on craving, but only three out of seven of the studies of nicotine gum. For other withdrawal symptoms the findings were more mixed. CONCLUSIONS: We conclude that the strength of evidence that oral nicotine forms reduce total withdrawal discomfort, irritability and anxiety is high. There is some evidence for an effect on depressed mood and craving although in the latter case the evidence is less good for gum than other forms. Future studies of nicotine effects on withdrawal should meet minimum quality standards for design and reporting to enable results to be combined and compared across studies.

Administration, Oral↗

A multi-dimensional analysis of cue-elicited craving in heavy smokers and tobacco chippers.

AIMS: This research examined the performance of a broad range of measures posited to relate to smoking craving. DESIGN: Heavy smokers and tobacco chippers, who were either deprived of smoking or not for 7 hours, were exposed to both smoking (a lit cigarette) and control cues. PARTICIPANTS: Smokers not currently interested in trying to quit smoking (n = 127) were recruited. Heavy smokers (n = 67) averaged smoking at least 21 cigarettes/day and tobacco chippers (n = 60) averaged 1-5 cigarettes on at least 2 days/week. MEASUREMENTS: Measures included urge rating scales and magnitude estimations, a rating of affective valence, a behavioral choice task that assessed perceived reinforcement value of smoking, several smoking-related judgement tasks and a measure of cognitive resource allocation. FINDINGS: Results indicated that both deprivation state and smoker type tended to affect responses across these measurement domains. CONCLUSIONS: Findings support the use of several novel measures of craving-related processes in smokers.

Adult↗

Smokers' beliefs about "Light" and "Ultra Light" cigarettes.

OBJECTIVE: To assess beliefs about the tar and nicotine delivery characteristics and health benefits of Light and Ultra Light cigarettes among cigarette smokers. DESIGN: Random digit dialed telephone survey conducted in September 1999. SUBJECTS: Daily smokers (n = 2120) of Regular (46%), Light (39%), and Ultra Light (15%) cigarettes in the USA. The sample was weighted to match the US smoker population on age, sex, and ethnicity. MAIN OUTCOME MEASURES: Beliefs about Light and Ultra Light cigarettes were summarised on three dimensions: Safety (reduced health risk), Delivery (lowered tar and nicotine delivery), and Sensation (less harsh). RESULTS: Most smokers believed Lights and Ultra Lights were less harsh and delivered less tar and nicotine. On average, smokers believed that Lights afforded a 25% reduction in risk, and Ultra Lights a 33% reduction in risk. Light and Ultra Light cigarette smokers evaluated the risks of their own cigarette types more favourably. Light smokers had greater interest in quitting than Ultra Light smokers. Quitting intention was modestly related to beliefs about these cigarettes. Believing that Lights and Ultra Lights delivered less tar and nicotine and that they were less harsh each independently contributed to the belief that these cigarettes were safer. CONCLUSIONS: Many Light and Ultra Light smokers believe that smoking these cigarettes impart a substantial health benefit, due in part to their experience that these cigarettes are less harsh and the belief that these cigarettes deliver less tar.

Adult↗

Effect of health messages about "Light" and "Ultra Light" cigarettes on beliefs and quitting intent.

OBJECTIVE: To test the impact of three health messages focusing on vent holes, sensory effects of Light and Ultra Light cigarettes, or health consequences of smoking, respectively, on beliefs and quitting intentions. DESIGN: In the course of a random digit dialed telephone survey, subjects were randomised to hear one of three messages. To test the effects of the messages, beliefs and quitting intentions were assessed both pre- and post-message. PARTICIPANTS: Daily smokers (n = 2120) of Regular (46%), Light (39%), and Ultra Light (15%) cigarettes in the USA. The sample was weighted to match the US smoker population on age, sex, and ethnicity. MAIN OUTCOME MEASURES: Beliefs were summarised on three dimensions: Safety (reduced health risk), Delivery (lower tar and nicotine delivery), and Sensation (less harsh). Quitting interest was captured by the "quit index", an aggregate measure of quitting interest and intent. RESULTS: The message focusing on smokers' sensory perceptions of Light and Ultra Light cigarettes resulted in the most positive change in beliefs about safety, delivery, and intent to quit, and was particularly effective among those who believed that these cigarettes were less harsh. The effect was most pronounced among young adults, and among smokers of Light and Ultra Light brands who most endorsed their sensory benefits. CONCLUSIONS: Addressing smokers' sensory experience that Light and Ultra Light cigarettes feel less harsh may be a promising strategy for changing their misconceptions about these cigarettes and enhancing their interest in quitting. Media counter-advertising on Lights and Ultra Lights, focusing on sensory aspects of these cigarettes, may be an important part of tobacco control efforts.

Adult↗

Test of "Light" cigarette counter-advertising using a standard test of advertising effectiveness.

OBJECTIVE: To evaluate systematically the effectiveness of six advertising strategies (two message strategies presented in three different contexts) designed to promote smoking cessation by addressing smokers' misperceptions about Light cigarettes. DESIGN: Smokers viewed one of six, 30 second test television concept advertisements, which varied by message (one emphasising how the sensory effects of Lights can be deceptive, the other describing the effects of vent blocking) and by ad context (non-commercial public service announcement (PSA), promotion of unbranded nicotine replacement therapy (NRT), or promotion of branded NRT). The effectiveness of each advertisement was determined using a validated advertising testing system in which ads were viewed in the context of reviewing a pilot television programme. Response to ads is assessed through shifts in subject choices of products offered as prizes before and after viewing the test advertisements. Included among the possible prizes were cigarettes and various pharmacotherapies for smoking cessation. SUBJECTS: Daily smokers (n = 1890) of Regular (34%), Light (47%), and Ultra Light (19%) cigarettes recruited from eight US cities. MAIN OUTCOMES MEASURES: The primary outcome of interest was the shift away from cigarettes as the selected prize following exposure to the test advertisements. Secondary outcomes of interest included movement away from Light cigarettes and movement towards assisted quitting products. RESULTS: Smokers who saw the advertisement emphasising the sensory characteristics of Light cigarettes were more likely than subjects who saw the advertisement emphasising the effect of vent blocking to move away from cigarettes (OR = 1.97, 95% confidence interval CI 1.25 to 3.09; chi(2)(1) = 8.69, p = 0.003). Similarly, subjects who saw the advertisement framed as a PSA, rather than as a promotion for either a branded or unbranded NRT product, were also somewhat more likely to move away from cigarettes (OR = 1.51, 95% CI 0.94 to 2.40; chi(2)(1) = 2.97, p = 0.085). The effect was observed regardless of sex, age, or type of cigarette smoked. CONCLUSIONS: Addressing smokers' sensory perceptions of Light cigarettes and presenting this information in an impartial way is likely to be an effective communication strategy for counter-marketing Light cigarettes.

Adult↗

Does smoking abstinence self-efficacy vary across situations? Identifying context-specificity within the Relapse Situation Efficacy Questionnaire.

According to self-efficacy and relapse theories. abstinence self-efficacy (ASE) ratings should be context-specific: they should vary across situations. This variability may be important, as it could signal high-risk for relapse situations. In this study, confirmatory factor analysis was used to identify situational variability in a novel ASE assessment (Relapse Situation Efficacy Questionnaire. or RSEQ). Results supported a hierarchical structure, where both context-specific and unidimensional measures of ASE exist within the assessment. Context-specific factors included Negative Affect, Positive Affect, Restrictive Situations (to smoking). Idle Time, Social-Food Situations, Low Arousal, and Craving. Multiple context-specific factors and the aggregate factor predicted cessation outcome, even after controlling for concurrent smoking rate. However, the context rated with the least confidence proved to be the best outcome predictor, suggesting the existence of "Achilles' heel" situations. These data indicate the internal and predictive validity of the RSEQ.

Adult↗

Cognitive-behavioral therapy to reduce weight concerns improves smoking cessation outcome in weight-concerned women.

Women smokers concerned about weight gain (N = 219) were randomly assigned to 1 of 3 adjunct treatments accompanying group smoking cessation counseling: (a) behavioral weight control to prevent weight gain (weight control); (b) cognitive-behavioral therapy (CBT) to directly reduce weight concern, in which dieting was discouraged; and (c) standard counseling alone (standard), in which weight gain was not explicitly addressed. Ten sessions were conducted over 7 weeks, and no medication was provided. Continuous abstinence was significantly higher at posttreatment and at 6 and 12 months of follow-up for CBT (56%, 28%, and 21%, respectively), but not for weight control (44%, 18%, and 13%, respectively), relative to standard (31%, 12%, and 9%, respectively). However, weight control, and to a lesser extent CBT, was associated with attenuation of negative mood after quitting. Prequit body mass index, but not change in weight or in weight concerns postquit, predicted cessation outcome at 1 year. In sum, CBT to reduce weight concerns, but not behavioral weight control counseling to prevent weight gain, improves smoking cessation outcome in weight-concerned women.

Adolescent↗

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine polacrilex gum therapy.

BACKGROUND: Standard, generic self-help materials have been largely ineffective as behavioral treatments for smoking cessation. In contrast, self-help programs tailored to the needs of specific smokers have shown promise in facilitating quitting. OBJECTIVE: To evaluate the incremental efficacy of the Committed Quitters Program (CQP), a set of computer-tailored materials offered to purchasers of nicotine polacrilex gum, compared with a briefuntailored user's guide and audiotape, both as supplements to nicotine replacement therapy. METHODS: We conducted a randomized, open-label trial with 3 parallel arms. Subjects were smokers who purchased 2- or 4-mg nicotine polacrilex gum and called the CQP toll-free enrollment line. Three thousand six hundred twenty-seven subjects consented to participate in 1 of 3 study arms: (1) those receiving the CQP materials (CQP group, n= 1,217), (2) those receiving CQP materials and an outbound telephone call (CQP + C group, n= 1,207); and (3) those receiving no supplemental intervention beyond the user's guide and audiotape that were prepackaged with the nicotine polacrilex gum (UG group, n= 1,203). Twenty-eight-day continuous abstinence rates were assessed by telephone interviews at 6 weeks and 10-week continuous rates at 12 weeks into treatment. RESULTS: Abstinence rates among respondents at the 6- and 12-week assessments were significantly higher for the CQP (36.2% and 27.6%) and CQP + C (35.5% and 27.3%) groups compared with the UG group (24.7% and 17.7%) at both intervals. The quit rates for the CQP and CQP + C groups were almost identical. CONCLUSIONS: The CQP proved to be an effective behavioral treatment, enhancing quit rates over and above nicotine replacement therapy and a brief untailored written guide and audiotape.

Adult↗

Current models of nicotine dependence: what is known and what is needed to advance understanding of tobacco etiology among youth.

Youth smoking has risen dramatically during the last 5 years, leading one to the conclusion that prevention interventions have not been particularly effective. This paper provides an examination of features that define adult nicotine dependence and argues that these features need to be considered in any studied examination of youth etiology and development to nicotine dependence. We review the historical context for the concept of nicotine dependence, features that define the concept and current models of substance dependence more generally. Recommendations for future research are provided.

Adolescent↗

Measuring nicotine dependence among youth: a review of available approaches and instruments.

This paper reviews issues and concepts related to the measurement of nicotine dependence among youth. The primary objectives of this review are to: (1) review the measures of nicotine dependence currently being used; and (2) delineate a future research agenda in an attempt to advance the quality of measurement and instrumentation for this important research endeavor. Existing measures of nicotine dependence, including formal diagnostic interviews, related withdrawal assessments, brief self-report measures, and single-item indicators, are described. While formal diagnostic systems have been considered the 'gold standard' for evaluating dependence clinically, their specific limitations related to use for research purposes are outlined. Each broad class of measure is evaluated in terms of its rationale for use, strengths and limitations, and the extent to which it has successfully been applied to adolescent populations. A research agenda follows in the second section of the paper. In this section, the need for identification and inclusion of a standard set of optimal dependence measures, for enhancement of current measures, and for the onset of a new and comprehensive measures development program is outlined.

Adolescent↗

Are adolescent smokers dependent on nicotine? A review of the evidence.

This paper reviews the empirical literature on adolescent nicotine dependence, withdrawal, and their associated features. Data documenting nicotine dependence scores, diagnoses, and individual features among adolescents are reviewed in detail and compared to observations based on adult smokers. These data are derived from a broad variety of sources, including national surveys, school-based surveys, and smoking cessation studies. Overall, results indicate that one to three out of five adolescent smokers is dependent on nicotine, with some adolescent groups clearly at higher risk for dependence (those who are incarcerated, in vocational schools, daily smokers, and/or heavy smokers). Across studies, data consistently indicate that a large majority (two-thirds or more) of adolescent smokers report experiencing withdrawal symptoms during attempts to quit or reduce their smoking. Craving or strong desire to smoke was the most commonly reported withdrawal symptom in every study reviewed. Although analyses of concurrent validity generally support the dependence and withdrawal findings among adolescents, data on the predictive validity of measures used are needed. Moreover, studies of adolescent tobacco withdrawal rely almost exclusively on retrospective self-report data. Recommendations for enhancing methodology and advancing our understanding of adolescent nicotine dependence and withdrawal are offered.

Adolescent↗

Impact of gender and having children in the household on ambulatory blood pressure in work and nonwork settings: a partial replication and new findings.

Ambulatory blood pressure (ABP) has been shown to differ for men and women across work and nonwork settings. For men, ABP is higher at work than at home on workdays or on nonworkdays. For women, ABP levels in different settings depend on whether they have children in the household. Women without children at home exhibit the "male" pattern of higher ABP at work than at home. Women with children at home show either similar ABP levels in the two locations or higher ABP at home. These different patterns have been assumed to represent different stress levels in the two locations, but this assumption has rarely been tested. Also, few studies have examined ABP levels on a nonworkday in women or the effect of having children in the household for men. The present study monitored ABP in men and women during two workdays and one nonworkday. Comparisons were made between ABP levels in three settings (workday at work, workday at home, nonworkday) using mixed random effects regression models. Psychosocial variables (e.g. mood, stress) that might mediate the different ABP patterns were also assessed. ABP differences were analyzed by gender and whether children were living in the household using mixed random effects regression models. Results indicated that diastolic blood pressure was higher at work versus home for men with children and higher at work and on nonworkdays than at home for women without children. ABP did not differ across settings for women with children or men without children. These results were not mediated by mood or stress levels in the three settings.

Adult↗