Showing papers in "Nicotine & Tobacco Research in 2003"

Measures of abstinence in clinical trials: issues and recommendations.

Abstract: A workgroup formed by the Society for Research on Nicotine and Tobacco reviewed the literature on abstinence measures used in trials of smoking cessation interventions. We recommend that trials report multiple measures of abstinence. However, at a minimum we recommend that trial: (a) report prolonged abstinence (i.e., sustained abstinence after an initial period in which smoking is not counted as a failure) as the preferred measure, plus point prevalence as a secondary measure; (b) use 7 consecutive days of smoking or smoking on > or = 1 day of 2 consecutive weeks to define treatment failure; (c) include non-cigarette tobacco use, but not nicotine medications in definitions of failure; and (d) report results from survival analysis to describe outcomes more fully. Trials of smokers willing to set a quit date should tie all follow-ups to the quit date and report 6- and/or 12-month abstinence rates. For these trials, we recommend an initial 2-week grace period for prolonged abstinence definitions; however, the period may vary, depending on the presumed mechanism of the treatment. Trials of smokers who may not be currently trying to quit should tie follow-up to the initiation of the intervention and should report a prolonged abstinence measure of > or = 6-month duration and point prevalence rates at 6- and 12-month follow-ups. The grace period for these trials will depend on the time necessary for treatment dissemination, which will vary depending on the treatment, setting, and population. Trials that use short-term follow-ups ( or = 4 weeks. We again recommend a 2-week grace period; however, that period can vary.

Evaluating transdisciplinary science.

Abstract: The past two decades have seen a growing interest and investment in transdisciplinary research teams and centers. The Transdisciplinary Tobacco Use Research Centers (TTURCs) exemplify large-scale scientific collaborations undertaken for the explicit purpose of promoting novel conceptual and methodological integrations bridging two or more fields. Until recently, few efforts have been made to evaluate the collaborative processes, and the scientific and public policy outcomes, of such centers. This manuscript offers a conceptual framework for understanding and evaluating transdisciplinary science and describes two ongoing evaluation studies covering the initial phase of the TTURC initiative. The methods and measures used by these studies are described, and early evaluative findings from the first 4 years of the initiative are presented. These data reveal progress toward intellectual integration within and between several of the TTURCs, and cumulative changes in the collaborative behaviors and values of participants over the course of the initiative. The data also suggest that different centers may follow alternative pathways toward transdisciplinary integration and highlight certain environmental, organizational, and institutional factors that influence each center's readiness for collaboration. Methodological challenges posed by the complexities of evaluating large-scale scientific collaborations (including those that specifically aspire toward transdisciplinary integrations spanning multiple fields) are discussed. Finally, new directions for future evaluative studies of transdisciplinary scientific collaboration, both within and beyond the field of tobacco science, are described.

An assessment of the validity of adolescent self-reported smoking using three biological indicators

Abstract: This research examined the validity of self-reports of adolescent smoking and explored factors that may influence agreement between self-reported smoking and biological indicators. Data were obtained from 1,881 adolescents as part of a household probability study in the southeastern United States. Adolescents aged 12-14 years reported their tobacco use and provided breath and saliva samples. The sensitivity and specificity of self-reports of smoking were calculated with measures of carbon monoxide, salivary cotinine, and salivary thiocyanate as standards. When the self-report items were compatible with the half-life of the biological indicator, and values were adjusted for smokeless tobacco use, sensitivity varied widely (carbon monoxide, 38%; cotinine, 81%-87%; thiocyanate, 80%). The range for specificity was more constrained (carbon monoxide, 98%; cotinine, 98%; thiocyanate, 80%). Sensitivity of self-report was influenced by the biological indicator examined and the timeframe of questions on smoking. Specificity of self-report was influenced by the biological indicator examined and use of other tobacco products. Overall, sensitivity and specificity were highest when recent smoking was assessed and when cotinine was the standard and smokeless tobacco use was considered. Examination of inhalation patterns suggested that detection of smoking may be influenced by recency of smoking and whether the adolescent smoker inhales. Assessments of individual adolescents' smoking were most accurate when smoking was recent and when cotinine was used and smokeless tobacco could be identified. Prevalence estimates of smoking were similar with self-reports and cotinine.

Hardening and the hard-core smoker: concepts, evidence, and implications.

Abstract: A nascent debate pits researchers who believe that hard-core smokers are coming to dominate the remaining population of smokers against others who perceive the hardening of the target as a far more distant concern. At stake is the future emphasis of tobacco control: should we alter the current allocation of resources between treatment of individual smokers and modification of the psychosocial environment through public education and policy measures? We review the evidence and conclude that: (1) hardening is probably occurring in the sense that, compared with earlier generations, many of today's smokers possibly do have greater difficulty quitting, or are inherently less willing to do so. (2) Hardening may be most usefully construed in the context of specific groups of smokers, such as the mentally ill, who may constitute a growing fraction of the remaining smoking population. (3) Using conventional measures, however, we find little evidence that the population of smokers as a whole is hardening. Cessation rates have not decreased. (4) Truly hard-core smokers necessarily constitute a very small fraction of the population. Quitting-susceptible smokers continue to dominate the smoking population. (5) Hardening and the potential existence of true hard-core smokers recommend creative thinking about, and devotion of resources to, finding new ways to help the most dependent smokers to quit. (6) Sound research recommends the expansion of comprehensive tobacco-control programs in both the public and private sectors, and does not support reallocation of resources from such programs toward more intensive individualized treatment. We can afford both.

Nicotine metabolite ratio as a predictor of cigarette consumption.

Abstract: The rate of nicotine metabolism is hypothesized to be a determinant of how much a person smokes. That is, rapid metabolizers would be expected to need more nicotine and, therefore, smoke more than slow metabolizers. Nicotine is metabolized extensively by the liver enzyme CYP2A6, primarily to cotinine. Cotinine is itself metabolized by CYP2A6 to 3'-hydroxycotinine (3-HC). The ratio of metabolite to parent (i.e., 3-HC:cotinine) would be expected to reflect CYP2A6 activity. We measured the ratio of 3-HC:cotinine in the urine of 72 smokers. This ratio was significantly correlated with the number of cigarettes smoked per day (r=.33, p=.005), though not with the Fagerstrom Test for Nicotine Dependence. This finding supports the hypothesis that the rate of nicotine metabolism is a determinant of the level of cigarette consumption and supports the use of the 3-HC:cotinine ratio as a noninvasive marker of nicotine metabolism.

Gender differences in quit rates following smoking cessation with combination nicotine therapy: influence of baseline smoking behavior.

Abstract: Women are less successful than men at quitting smoking. We examined whether the male vs. female cessation outcome was influenced by baseline smoking behavior in participants who attempted to quit by using nicotine inhaler (NI) plus nicotine patch (NP) combination therapy. This double-blind, randomized, placebo-controlled trial enrolled 196 men and 204 women. Group 1 (99 men, 101 women) received NI plus NP (15 mg nicotine/16 h) for 6 weeks, then NI plus placebo patch (PP) for 6 weeks, then NI alone for 14 weeks. Group 2 (97 men, 103 women) received NI plus PP for 12 weeks, then NI alone for 14 weeks. Outcome measures were continuous self-reported abstinence and expired carbon monoxide concentration < 10 ppm. Baseline nicotine dependence was assessed by the Fagerstrom Test for Nicotine Dependence (FTND), and behavioral dependence by the 18-question Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ). Male vs. female complete abstinence rates, regardless of treatment group, were 61.7% vs. 46.6% at 6 weeks (p = .0022), 42.3% vs. 30.9% at 12 weeks (p = .017), 30.1% vs. 17.6% at 6 months (p = .003), and 23.0% vs. 10.8% at 12 months, respectively (p = .001). Men had significantly higher baseline FTND (p = .0180) and lower total GN-SBQ (p < .0001) scores than women. In conclusion, women appear to have higher behavioral, and lower nicotine, dependence than men according to the GN-SBQ and the FTND; thus both nicotine and behavioral treatment should be tailored to women to increase their chances of abstinence.

Nondaily smokers: a descriptive analysis.

Abstract: To describe the characteristics of persons in the United States who smoke but do not smoke daily, we analyzed 1997-1998 data from the National Health Interview Survey (NHIS). The NHIS collects self-reported information on cigarette smoking from a representative sample of the U.S. civilian, noninstitutionalized population aged 18 years or older through in-home surveys. Nondaily smokers were defined as persons who had ever smoked 100 cigarettes, smoked "some days," and smoked on fewer than 30 of the past 30 days. In 1997-1998, an estimated 16.0% of current smokers were nondaily smokers. Being a nondaily smoker was more common among smokers aged 18-24 years (19.9%) than among those aged 45-64 years (12.0%), more common among Black and Hispanic smokers (19.2% and 29.9%, respectively) than among White smokers (13.9%), and more common among smokers with at least a college education (28.2%) than among those with 9-11, 12, or 13-15 years of education (10.0%, 12.5%, or 15.9%, respectively). Mean cigarettes smoked per day for those who had smoked on 1-9, 10-19, and 20-29 of the past 30 days equaled 3.9, 5.3, and 7.0, respectively, compared with 19.0 for daily smokers. Nondaily smokers were more likely than daily smokers to have a quit attempt in the past year (55.2% vs. 40.0%). In conclusion, rates of nondaily smoking vary substantially by age, race/ethnicity, and educational attainment. Differences by education suggest that this behavior may be influenced by knowledge and social norms. Nondaily smoking may be a useful intermediate outcome for assessing changes in smoking prevalence. Cessation interventions need to be tailored for nondaily smokers, who may differ from daily smokers in important ways.

Predictors of susceptibility to smoking and ever smoking: a longitudinal study in a triethnic sample of adolescents.

Abstract: This report describes a longitudinal study of the natural course of smoking initiation in a school-based, ethnically diverse (42% White, 37% African American, 20% Hispanic) sample of adolescents in grades 5, 8, and 12 who were followed prospectively for 1 year. A cohort of 659 students was identified who were never smokers at baseline and who completed questionnaires both at baseline and at 1-year follow-up. From this cohort, predictor variables were used to identify ethnic-specific risk factors for (a) "susceptibility to smoking" among the 509 students who were nonsusceptible, never smokers at baseline and (b) "ever smoking" among all 659 students who were never smokers at baseline (both susceptible and nonsusceptible). Logistic regression analyses revealed that parental and household influences (parental education, marital status, household smoking) were important predictors of ever smoking, but not of susceptibility to smoking, for African Americans. Hispanic adolescents were significantly influenced by environmental influences, namely smoking by other household members (ever smoking) and by peers (susceptibility and ever smoking), although peer pro-tobacco influences (friends who smoke or friends' approval of smoking) were important predictors of susceptibility to smoking or ever smoking for all three ethnic groups. Exposure to tobacco-related advertising was a risk factor for White (susceptibility and ever smoking) and African American (susceptibility only) adolescents but not for Hispanic adolescents. Inclusion of the susceptibility to smoking variable in the model predicting ever smoking substantially reduced the importance of other predictors in the model, suggesting that susceptibility to smoking was not an independent risk factor for ever smoking but rather a potential mediating variable. The results of this study offer important insights for designing ethnic-specific strategies for preventing smoking during adolescence.

Protecting children from environmental tobacco smoke (ETS) exposure: a critical review.

Abstract: Environmental tobacco smoke (ETS) is a significant public health burden. This review summarizes empirical evidence for reducing residential ETS exposure in youth in 19 studies published between 1987 and 2002. Most studies have investigated minimal contact, physician office-based interventions, although some have been conducted in homes and have been more intensive. Interventions are compared based on study design, type of intervention, sample characteristics (asthmatic or healthy), goals, and outcomes, including effect sizes. The average effect size (Cohen's d) was .34, with a range from -.14 to 1.04. The evidence suggests that interventions can be effective in reducing children's exposure. More rigorous study designs, interventions of greater intensity and duration, and those based on sound behavior change theory have yielded the most promising results. Challenges and limitations in this area of study are examined. A model for ETS interventions is proposed, and directions for future research are set forth.

The heritability of failed smoking cessation and nicotine withdrawal in twins who smoked and attempted to quit.

Abstract: The magnitude of the association between nicotine withdrawal and failed smoking cessation remains uncertain, and the potential genetic contribution to that relationship is unknown. We used a twin design study to test if genetic and environmental risk factors contribute to nicotine withdrawal and failed cessation. We then estimated the magnitude of genetic and environmental risk factors and the associated correlations. Cigarette consumption data were obtained in 1992 from 4,112 (1,806 pairs, 496 singletons) male twin pairs from the Vietnam Era Twin Registry. Participants responded to a telephone administration of the Diagnostic Interview Schedule. Odds ratios were computed for failed smoking cessation as a function of 12 individual nicotine withdrawal symptoms. Genetic model fitting was performed on a sample of 1818 twin pairs, all of whom were lifetime smokers; both twins of the pairs had made at least one quit attempt. After adjustment for cigarette consumption, odds of failed smoking cessation ranged from.87 (95% CI.76-.99) for "increased appetite/weight gain" to 1.85 (95% CI 1.55-2.22) for "depressed." Genetic influences accounted for 54% and 29.7% of the variance in risk for failed smoking cessation and nicotine withdrawal, respectively. The correlation between genetic influences was significant (r=.31, 95% CI.17-.45). The magnitude of the association between failed cessation and nicotine withdrawal varied by symptom. The risk of experiencing nicotine withdrawal after a quit attempt was related partly to genetic vulnerability; lifetime risk for both failed cessation and nicotine withdrawal was related partly to genetic factors that were correlated.

Treatment of adolescent smokers with the nicotine patch

Abstract: This study examined the effects of the nicotine patch on craving and withdrawal symptoms, safety, and compliance among adolescents. The secondary goal was to conduct a preliminary investigation of the effectiveness of the nicotine patch in helping adolescents quit smoking. The study design was a double-blind, placebo-controlled, randomized trial of the nicotine patch. The intervention also provided intensive cognitive-behavioral therapy and a contingency-management procedure. Participants (n=100) attended 10 treatment visits over 13 weeks. Compared with the placebo patch group, the active nicotine patch group experienced a significantly lower craving score and overall withdrawal symptom score (p=.011 and p=.025, respectively), as well as a time trend toward lower scores (p<.001) in craving only. Moreover, the nicotine patch appeared safe for adolescents to use. No differences by treatment group were found in experiencing adverse events, except that the participants in the placebo patch group reported more headaches than those in the active nicotine patch group. As another measure of safety, the overall mean salivary cotinine levels were significantly lower at 1, 6, 8, and 10 weeks postquit (all p<.05) compared with baseline levels, although these results were confounded by dropouts. Additionally, a significant number of participants were compliant with using the nicotine patch daily. Finally, point prevalence (7-day and 30-day abstinence rates) and survival analysis of participant abstinence indicated no significant differences between treatment groups. The results of this study suggest that the nicotine patch is a promising medication and a larger clinical trial of the nicotine patch among adolescents is warranted.

Evaluation of an Internet-based smoking cessation program: lessons learned from a pilot study.

Abstract: The potential contribution of the Internet to smoking cessation seems huge, given that a majority of Americans now have both computers and telephones. Despite the proliferation of Web sites offering smoking cessation support, there is little empirical evidence regarding the efficacy of Internet-delivered cessation programs. We developed a cessation Web site and conducted a short-term evaluation of it, examining recruitment approaches, Web site use patterns, alternative retention incentives and re-contact modes, satisfaction, and cessation rate. The intervention included modules on social support and cognitive-behavioral coping skills configured to take advantage of the interactive and multimedia capabilities of the Internet. Cessation and satisfaction data were obtained from a subsample of 370 subjects followed for 3 months. The program was rated as easy to use, and the social support group component was used most frequently. The cessation rate (abstinence for the previous 7 days) at 3 months was 18%, with nonrespondents (n=161) considered smokers. Among a variety of traditional and Internet-based recruitment strategies, the most successful made use of Internet user groups and search engines. Methodological and procedural issues posed in conducting research on the Internet are discussed.

Smoking topography: Reliability and validity in dependent smokers

Abstract: Data from two studies were analyzed to determine whether smoking through the mouthpiece of a topography unit yields consistent measures over time and to verify that smoking through a mouthpiece results in a similar degree of smoke exposure as conventional smoking. In both studies, subjects smoked their usual brand of cigarette ad libitum. In study A, subjects (n=7) smoked through a mouthpiece on 4 separate experimental days. In study B, subjects (n=10) smoked on 2 separate days: Once conventionally and once through a mouthpiece. In both studies, exhaled carbon monoxide (CO) and physiological effects (heart rate and blood pressure) were measured before and after smoking. In study B, plasma nicotine concentrations also were measured. In study A, puff volume, puff duration, interpuff interval, and maximum puff velocity averaged 30.8 ml,.9 s, 19.9 s, and 44.6 ml/s, respectively. Intraclass correlation coefficients computed for puff volume (0.66), puff duration (0.75), and maximum puff velocity (0.68) indicated that these measures showed good reliability. In study B, smoking through the mouthpiece yielded similar topographical (time to smoke and number of puffs per cigarette) measures as conventional smoking. Also similar were changes in biochemical values: Plasma nicotine (18.5 ng/ml vs. 25.5 ng/ml), exhaled CO (4.6 ppm vs. 5.1 ppm), and heart rate (8.6 beats/min vs. 7.4 beats/min) for conventional and topography mouthpiece smoking conditions, respectively. Topography measures did not differ significantly between the two studies. Overall, the data from these two small-sample studies suggest that smoking topography provides a valid and reliable index of conventional smoking and an indirect measure of smoke exposure.

Is use of smokeless tobacco a risk factor for cigarette smoking? The U.S. experience.

Abstract: Some researchers are promoting the use of smokeless tobacco as safer than cigarette smoking and as a possible method for quitting smoking, but smokeless tobacco might be a gateway drug that leads to smoking, and the availability and marketing of smokeless tobacco may keep smokers from quitting. This study assessed 4-year initiation rates of smokeless tobacco use and cigarette smoking in relation to each other and examined switching between the products. Data were from the 1989 Teenage Attitudes and Practices Survey and its 1993 follow-up study, comprising a nationally representative U.S. cohort of 7,960 people aged 11-19 years at baseline. Analyses were limited to males with complete data on smoking and smokeless tobacco use at both interviews (n=3,996). Young males who were not smokers in 1989 but regularly used smokeless tobacco were more than three times as likely as never users to be current smokers 4 years later (23.9% vs. 7.6%), adjusted OR=3.45 (95% CI=1.84-6.47). In contrast, 2.4% of current smokers and 1.5% of never smokers at baseline became current regular smokeless tobacco users by follow-up. More than 80% of baseline current smokers were still smokers 4 years later, and more than 40% of baseline current regular smokeless tobacco users became smokers either in addition to or in place of smokeless tobacco use. It appears that smokeless tobacco may be a starter product for subsequent smoking among young U.S. males but may have little effect on quitting smoking.

Science for hire: a tobacco industry strategy to influence public opinion on secondhand smoke.

Abstract: A review of internal tobacco company documents reveals that members of the tobacco industry and its corporate attorneys created an international scientific consultants program to influence public opinion on environmental tobacco smoke (ETS). This program was shaped as a "product" to protect the industry from international threats of smoking restrictions. Additionally, this program was used to promote a scientific backdrop supporting the industry's position on ETS that differed from regulatory agencies and published scientific research. In this report, we detail the pervasive nature of the so-called ETS Consultants Program, outline the wide range of activities undertaken by the consultants, and highlight the role of the industry's corporate attorneys in creating and managing this program. We suggest heightened monitoring of industry-created scientific organizations, further tobacco document research, and wide dissemination of such work.

Measuring nicotine intake in population surveys: comparability of saliva cotinine and plasma cotinine estimates.

Abstract: Both plasma and saliva cotinine levels have been reported in surveys of smoking behavior, and it is of interest to know how closely these two measures correspond. Plasma and saliva specimens were gathered from a sample of 605 respondents in the 1998 Health Survey for England and assayed for cotinine by a well-proven gas chromatographic method. Plasma and saliva cotinine concentrations were highly correlated (r=.99). On average, concentrations in saliva were 25% higher than in plasma, and this ratio applied both at the low levels attributable to passive smoking and across the range of active smoking values. The ratio was somewhat lower in younger people than in older people and also varied significantly by body mass index but did not differ by gender. Calculation of the limits of agreement revealed substantial uncertainty in the predicted plasma value corresponding to a given saliva cotinine, and vice versa. For comparisons across subjects, the mean plasma cotinine level corresponding to a mean saliva cotinine level can be estimated with confidence, but at the level of the individual, considerable predictive uncertainty remains.

Psychiatric disorders, familial factors and cigarette smoking: I. Associations with smoking initiation.

Abstract: The aims of this study were to examine associations between smoking initiation (five cigarettes lifetime) and lifetime psychopathology, regular smoking by family members, and psychopathology in family members; to describe the degree to which the onset of the disorder precedes or follows smoking initiation; and to examine whether smoking initiators differ as a function of age of smoking onset. Nine hundred and forty-one participants were interviewed at three time points, beginning in high school and most recently at age 24. Lifetime psychiatric diagnoses were obtained at each assessment, as were data regarding smoking initiation. Biological parents and full siblings were interviewed for lifetime psychopathology and regular smoking. Most measures of lifetime psychopathology were associated with smoking initiation. Rates of initiation were especially elevated in participants with multiple disorders. Regular smoking by mother and a sibling (but not father) was associated significantly with smoking initiation, as were two of four measures of psychopathology in relatives. When all significant univariate variables were examined in a single model, drug use disorders, regular smoking by mother, and regular smoking by a sibling remained significantly associated with smoking initiation. Smoking initiation preceded approximately half of the examined diagnostic categories. Eleven variables differentiated early vs. late smoking initiators. Several interactions with gender were found. In every instance, smoking initiation was more strongly associated with the risk factor for young women than for young men. To our knowledge, this is the first time that the relations of psychopathology and familial factors with smoking initiation have been examined simultaneously or in this much detail. Results underscore the potential importance of assessing and treating psychiatric disorders in smoking prevention and cessation efforts.

Self-reported health status, health vulnerability, and smoking behavior in college students: Implications for intervention

Abstract: Health-related factors, including prevalence of respiratory symptoms and perceived health status, were analyzed by smoking status and by stages of change for quitting to evaluate their potential use as motivators for tobacco cessation. Data were obtained from a survey of 1,283 Houston-area community college students. Respiratory symptoms were most frequent among current smokers and least frequent among never smokers. A higher prevalence of reported respiratory symptoms was associated with being in later stages of readiness to change. An "optimism bias" regarding smoking-related health was evident among smokers; over half of the current smokers believed that their health was better than the average same-age smoker's health, and 19% believed that their health was better than that of the same-age nonsmoker. Furthermore, virtually all of the smokers perceived that their health was either not at all or only slightly affected by smoking, and almost half of smokers thought that quitting would bring either no benefit or only minor benefit to their health. Of the smokers, 45% believed that continuing to smoke would have only minor or no impact on their health. Differences in perceived health vulnerability were observed across the various stages of readiness to quit; precontemplators reported the lowest perceptions of health vulnerability related to smoking, and those in the preparation stage reported the highest perceptions of vulnerability. Smoking cessation counselors should consider measuring and demonstrating the early tobacco-attributable health problems to young smokers to possibly enhance motivation to quit.

Successful recruitment of minorities into clinical trials: The Kick It at Swope project

Abstract: Ethnic minorities are often underrepresented in clinical trials, and their recruitment can challenge researchers. Developing and communicating effective and efficient recruitment strategies may help researchers enroll more minorities into research studies. Kick It at Swope was a double-blind, randomized trial that evaluated bupropion for smoking cessation among 600 adult African Americans who smoked 10 or more cigarettes a day. Proactive recruitment strategies (in-person appeals by study staff and health care providers) and reactive recruitment strategies (disseminating information that asked people to call a study hotline) were implemented sequentially in an additive fashion over 16 months. Resulting patterns of recruitment are described and the two phases are compared based on their relative effectiveness, efficiency, and cost. More enrollees were recruited in the reactive phase (n=534) than in the proactive phase (n=66). Those recruited in the reactive phase were more likely to be eligible (OR=4.8) and more likely to be enrolled (OR=4.2) than those recruited in the proactive phase. Participants recruited in the reactive phase reported significantly higher levels of education and income, better health, and significantly lower indicators of depression and life hassles, compared with those recruited in the proactive phase. The reactive recruitment phase was less expensive than the proactive recruitment phase (22 US Dollars/enrollee vs. 159 US Dollars/enrollee). Reactive recruitment strategies added to multiple proactive clinic-based recruitment strategies were more effective, more efficient, and less costly than proactive recruitment alone. Close monitoring combined with the use of multiple recruitment methods and flexible recruitment plans can lead to successful, efficient, and low-cost recruitment of minorities into clinical trials.

The increasing recalcitrance of smokers in clinical trials II: Pharmacotherapy trials.

Abstract: Irvin and Brandon (Nicotine & Tobacco Research, 2, 79-84, 2000) reported a significant decline in reported abstinence rates between 1977 and 1996 from clinical trials of cognitive-behavioral smoking cessation treatments based on coping skills training. The present study extends that approach to the analysis of pharmacotherapy trials. A literature search identified 59 studies, published between 1983 and 2000 and conducted in the U.S., that reported post-cessation abstinence rates after treatment with nicotine gum, nicotine patch or any type of placebo medication. Across all three types of treatment conditions and four post-cessation assessment points, negative correlations between publication year and abstinence rates were found. The strongest pattern of negative correlations was found for the placebo conditions. However, the correlations for placebo conditions could be accounted for by the simultaneous shift toward treatments offered in individual rather than group format. No other methodological or subject variable appeared to mediate the declining outcomes. Findings are discussed with respect to the theory that the population of remaining smokers is becoming progressively more dependent and difficult to treat.

Pharmacokinetics of a nicotine polacrilex lozenge

Abstract: To evaluate the pharmacokinetic characteristics of the 2-mg and 4-mg nicotine polacrilex lozenges, the following four separate studies were conducted in healthy adult smokers: (a) A single-dose, four-way crossover (replicate design) study to compare the 4-mg lozenge and the 4-mg nicotine polacrilex gum, (b) a single-dose, two-way crossover study to compare the 2-mg lozenge and the 2-mg gum, (c) a multiple-dose, four-way crossover study to compare the lozenges administered every 90 min and the gums administered every 60 min at 2- and 4-mg dose levels, and (d) a single-dose, three-way crossover study to compare the pharmacokinetic profiles of the 4-mg lozenge when administered in three different ways: (i) Used as directed, (ii) chewed and immediately swallowed, and (iii) chewed, retained in the mouth for 5 min, and then swallowed. The single-dose studies consistently demonstrated 8%-10% higher maximal plasma concentrations and 25%-27% higher AUC values (area under the concentration-time curve) from the lozenges compared with the gums at the 2- and 4-mg dose levels, probably owing to the residual nicotine retained in the gum. The multiple-dose study applying different dosing intervals (i.e., every 90 min for the lozenges and every 60 min for the gums) resulted in approximately 30% lower AUC(0-t) values for the lozenges compared with those for the gums. Administration of the lozenge contrary to the label-specified instructions for use did not lead to a faster or higher absorption of nicotine. These pharmacokinetic characteristics should allow the lozenge to become an effective and safe therapeutic alternative for smoking cessation.

Tobacco Craving Questionnaire: reliability and validity of a new multifactorial instrument

Abstract: This study documented the initial reliability and validity of the Tobacco Craving Questionnaire (TCQ), a new multidimensional questionnaire to assess tobacco craving. Current cigarette smokers (n=213) not attempting to reduce or quit smoking completed the 47-item TCQ and other forms assessing demographics, tobacco and other drug use history, quit attempts, and current mood. Exploratory factor analyses and structural equation modeling indicated that a four-factor solution best described the item structure. Factor subscales derived from the 17 items with significant loadings had low to high internal consistencies and interitem correlations and exhibited low to moderate, positive intercorrelations. Factor scales were significantly correlated with single-item measures of craving, current mood, and daily cigarette smoking. Results indicated that four specific constructs characterized craving for tobacco: (a) Emotionality, or smoking in anticipation of relief from withdrawal symptoms or negative mood, (b) expectancy, or anticipation of positive outcomes from smoking, (c) compulsivity, or an inability to control tobacco use, and (d) purposefulness, or intention and planning to smoke for positive outcomes. These preliminary data suggest that the TCQ is a reliable and valid instrument for assessing tobacco craving in individuals not attempting to reduce or quit smoking.

Tobacco smoke exposure and decreased serum and red blood cell folate levels: Data from the Third National Health and Nutrition Examination Survey

Abstract: The aim of this cross-sectional study was to determine the effects of smoke exposure on serum and red blood cell folate levels. Data collected as part of the Third National Health and Nutrition Examination Survey were analyzed. Serum and red blood cell folate levels were measured in active smokers and nonsmokers with high, moderate, and low exposure to environmental tobacco smoke. After adjusting for dietary intake of folate and other covariates, we found that both smokers and nonsmokers with high smoke exposure had lower red blood cell folate levels than did nonsmokers with low smoke exposure (-86 nmol/l [95% confidence interval, CI, -101 to -71 nmol/l] for smokers; -50 nmol/l [95% CI -69 to -31 nmol/l] for nonsmokers with high smoke exposure, compared with nonsmokers with low smoke exposure). Similarly, after adjustment of dietary intake of folate and other covariates, the log serum folate level also was decreased (-0.29 log nmol/l [95% CI -0.33 to -0.25 log nmol/l] for smokers; -0.16 log nmol/l [95% CI -0.20 to -0.12 log nmol/l] for nonsmokers with high smoke exposure, compared with nonsmokers with low smoke exposure). Tobacco smoke exposure is associated with decreased folate levels, which may be a mechanism for some of the health effects of active and passive smoking.

Exploring the cultural context of tobacco use: a transdisciplinary framework.

Abstract: Understanding culture is an essential key to reducing tobacco use. Conceptualizations of culture vary across scientific disciplines and theoretical orientations. Because of the complexity of the causes and effects of tobacco use, no single discipline has sufficient capacity to undertake a comprehensive approach to studying culture and tobacco. Transdisciplinary research offers a means of bridging disciplinary perspectives. This paper reviews epidemiological data on observed variation in smoking patterns across national groups, ethnicities and genders, and presents reasons for studying culture in tobacco control research. We discuss and contrast conceptualizations and specific definitions of culture and identify aspects of each conceptualization that are relevant to research on tobacco. We present a multilevel, multidimensional conceptual framework for transdisciplinary research teams to use to think together about the influence of culture on tobacco and of tobacco on culture. The framework challenges researchers to think about how the sociocultural context influences tobacco use at micro, meso, and macro levels. Finally, we offer suggestions for improving transdisciplinary research on culture and tobacco.

Targeting smokers at increased risk for relapse: treating women and those with a history of depression.

Abstract: Some studies have shown that female smokers and smokers with a history of depression have an increased risk of relapse following smoking cessation treatment. This study examined the efficacy of bupropion sustained-release (SR) and the nicotine patch for smoking cessation in subgroups of smokers at possible risk for relapse. Data for this study were from a previously published randomized, double-blind, placebo-controlled clinical trial in which 893 smokers were randomized to four treatment conditions: placebo tablet + placebo patch, placebo tablet + 21 mg/24-hr nicotine patch, 300mg bupropion SR + placebo patch, and 300mg bupropion SR + 21 mg/24-hr nicotine patch. Study medication continued for 8 weeks after the quit day; brief individual cessation counseling was provided during weekly clinic visits. In comparison to the placebo tablet, bupropion SR approximately tripled 1-year non-smoking rates among women and previously depressed individuals. In contrast, the nicotine patch did not significantly improve cessation rates for any group. We conclude that bupropion SR is a first-line treatment for smoking that has the potential to benefit all smokers, especially women and the previously depressed.

Bupropion SR and counseling for smoking cessation in actual practice: predictors of outcome.

Abstract: To date, only one study has been published on individual characteristics associated with outcome following standard treatment with bupropion SR for smoking cessation. To investigate treatment outcome beyond the 6-week end-of-treatment point, the present study examined characteristics associated with more clinically relevant smoking endpoints following treatment with bupropion SR in a large health care system. A total of 1,524 smokers (649 men and 875 women) of average age 45.1 years were randomized to receive one of four combinations of bupropion SR (150 or 300 mg) and behavioral counseling (tailored mailings or proactive telephone counseling) and assessed for point-prevalent smoking status at 3 and 12 months. Multiple logistic regression analyses of potential risk factors for 12-month point-prevalent smoking and for persistent smoking (point-prevalent smoking at both follow-ups) following treatment were conducted for men and women combined and separately. Risk factors for smoking at both endpoints in the combined sample included treatment with tailored mailings, female gender, younger age, higher levels of tobacco dependence, shorter previous quit attempts, previous use of nicotine replacement therapy, and report of current depressive symptoms or lifetime depression. Risk factors for smoking following treatment identified in women only included treatment with the lower dose of bupropion SR, younger age, and higher perceived stress, whereas those that were unique to men included the presence of lifetime depression. The results are discussed in terms of their implications for the need for more effective treatments in general, and the role of individual differences in the likelihood of returning to smoking following treatment for quitting.

A comparison of self-report measures of nicotine dependence among male drug/alcohol-dependent cigarette smokers.

Abstract: This study examined the psychometric properties and validity of the Fagerstrom Tolerance Questionnaire (FTQ), the Fagerstrom Test for Nicotine Dependence (FTND), and the Heaviness of Smoking Index (HSI) when used as self-report measures of nicotine dependence among male drug/alcohol-dependent smokers (n=191 participants in a large stop-smoking study). All three measures had fairly low internal consistency. The FTQ and FTND had similar two-factor structures, but the FTND factor structure accounted for a greater percentage of the item variance. All three measures were significantly correlated in the expected directions with several independent self-report and biochemical indicators of nicotine dependence (e.g., cigarette pack-years, cotinine) and with baseline measures of smoking topography. The FTND outperformed the FTQ on several correlations, and the HSI outperformed both the FTQ and the FTND. Results concerning correlations between each of the three measures and indicators of compensation in response to reductions in nicotine availability were equivocal. The HSI and FTND were predictive of at least 4 weeks of biochemically verified postquit abstinence among a subsample of individuals receiving smoking treatment (n=93). All three measures had mediocre psychometric properties, and the magnitudes of their relationships with independent indicators were generally modest. All three measures appeared to be valid as self-report measures of nicotine dependence among male drug/alcohol-dependent individuals. The HSI appeared to be the best of the three measures; thus, studies of drug/alcohol-dependent smokers should be sure to report the results from this measure. Efforts to develop self-report measures of nicotine dependence with better properties and performance in this population should continue to be pursued.

A factor analysis of the Fagerström Test for Nicotine Dependence (FTND).

Abstract: Psychometric study of the Fagerstrom Test for Nicotine Dependence (FTND) provides insight into its structure and the dimensions of nicotine addiction it assesses We evaluated the factor structure of the FTND in 541 research volunteers, most with histories of polysubstance use Tetrachoric and phi correlation techniques were utilized and promax- and varimax-rotated solutions are reported Two factors were found Factor 1 was defined by questions regarding time to first cigarette in after waking, which cigarette is most preferred, and prominence of morning smoking Factor 2 was defined by questions regarding difficulty refraining from smoking, amount smoked, and smoking while ill The question "How soon on waking do you smoke your first cigarette?" loaded substantially on both Factor 2 and Factor 1 Repeating the analyses after stratification by gender did not change the results The factor structure from our sample population was similar to results reported by previous studies with different types of populations We propose that Factor 1 assesses the degree of urgency to restore nicotine levels to a given threshold after nighttime abstinence, whereas Factor 2 reflects the persistence with which nicotine levels are maintained at about that threshold during waking hours Thus, the FTND may assess distinguishable self-reportable pharmacological dimensions of nicotine addiction These two dimensions may provide indirect assessment of a smoker's daily nicotine intake Testing this hypothesis requires correlation of biomarkers and responses to specific items of the FTND