Assigning dose of nicotine gum by time to first cigarette.

INTRODUCTION: Nicotine gum, a proven effective aid to cessation, comes in two doses: 2-mg and 4-mg. Assignment to the higher dose has traditionally been based on daily cigarette consumption. This paper evaluates efficacy of the gum when the 4-mg dose is assigned based on time to first cigarette (TTFC) being ≤ 30 min. METHODS: In a secondary analysis of a randomized, double-blind, placebo-controlled trial that allocated smokers randomly to placebo, 2-mg, or 4-mg gum (Garvey, A. J., Kinnunen, T., Nordstrom, B. L., Utman, C. H., Doherty, K., Rosner, B., et al. (2000). Effects of nicotine gum dose by level of nicotine dependence. Nicotine & Tobacco Research, 2, 53-63. doi:10.1080/14622200050011303), we evaluated outcomes when 4-mg gum was given to subjects with TTFC ≤ 30 (n = 158, placebo n = 159). RESULTS: Active treatment doubled or tripled abstinence rates versus placebo. This also held among smokers with a history of treatment failure. The effect of 4-mg gum was significant among light smokers (<25 CPD) with TTFC ≤ 30; 2-mg gum was not. CONCLUSION: This analysis suggests that assigning dose of nicotine gum based on TTFC is an effective and appropriate means of dose allocation.

Front-loaded versus weekly counseling for treatment of tobacco addiction.

INTRODUCTION: Approximately 60%-70% of cigarette smokers who try to quit relapse by 2 weeks postcessation. We tested the efficacy of a front-loaded (FL) counseling intervention whose goal was to increase the likelihood of successful early abstinence and subsequent long-term abstinence. METHODS: We randomized 278 adult smokers to an FL or weekly behavioral smoking cessation counseling schedule. The total number of sessions across treatment was the same for both groups. However, those assigned to the FL schedule received 6 counseling sessions in the first 2 weeks postcessation, while those in the weekly condition received 2 sessions. Participants in both groups also received standard nicotine patch treatment. RESULTS: At 1 year postcessation, FL participants were significantly less likely to have relapsed when continuous abstinence was used as the definition of abstinence/relapse (11.7% abstinent vs. 6.3%, hazard ratio [HR] = 0.69, p = .007); and there were nonsignificant trends for FL subjects to have better outcomes when abstinence was defined as never smoking for 7 or more consecutive days nor for 7 or more consecutive episodes (18.4% abstinent vs. 14.8%, HR = 0.83, p = .20) and as point prevalence abstinence (15.6% abstinent vs. 12.9%, p = .11). The relationship between FL counseling treatment and continuous abstinence was partially mediated by higher postcessation levels of social support perceived from counseling and greater use of cessation-related coping strategies. CONCLUSIONS: We conclude that FL counseling is a promising treatment model that should be evaluated further, perhaps using modifications of the FL schedule used in this study.

Effect of compliance with nicotine gum dosing on weight gained during a quit attempt.

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 <9 pieces/day, P = 0.017), but participants randomized to the placebo group saw no such benefit from compliant use. A similar compliance-treatment interaction (P = 0.046) was also observed when the effect of compliance was examined within active treatment (2 mg versus 4 mg). CONCLUSIONS: When smokers are quitting, those who use more pieces of nicotine gum experience less weight gain in the first 30 days. This relationship is not seen for smokers on placebo gum.

A prospective study of persistence in the prediction of smoking cessation outcome: results from a randomized clinical trial.

Research has had mixed success in identifying pretreatment variables which can be used to guide treatment and enhance outcome. A critical first step in the process is to identify variables that reliably predict outcome. Some recent studies, largely retrospective, have found mixed evidence on the relationship between task persistence and smoking outcome measures. In the present study, we use data from a randomized clinical trial (N=241) to prospectively investigate the ability of persistence to predict outcome. Findings from multivariate analyses did not support our hypotheses: persistence did not predict outcome. We discuss these findings in relation to previous studies by focusing on theoretical and measurement issues related to the study of persistence in smoking cessation research. We conclude by recommending directions for future research, including conceptual clarification of the relationship between persistence and theoretically related constructs and investigations of variables that may moderate relationships between these constructs and cessation outcome.

Role of nicotine gum and pretreatment depressive symptoms in smoking cessation: twelve-month results of a randomized placebo controlled trial.

OBJECTIVE: The aim was to investigate the role of nicotine gum and pretreatment depressive symptoms in long-term smoking cessation. METHODS: 12-month follow-up of 608 participants within a randomized, controlled trial was conducted. Participants received brief counseling plus nicotine or placebo treatment. Based on the Center for Epidemiological Studies Depression Scale pre-treatment score (> or =16), 32% of the participants were classified as depressed at baseline. RESULTS: At the 12-month follow-up the non-depressed participants with nicotine replacement therapy (NRT) were most successful (20.1%), while the depressed ones with placebo were least successful (5.7%) (p = .004). However, the depressed participants with NRT (15.1%) were not significantly less successful than the non-depressed ones with NRT (20.1%, p = .23). Survival analysis showed significant depression (p = .01) and treatment effects (p = < .001) on the abstinence. Further, when adjusted for marital status and education, the treatment effect remained significant (p < .001), whereas the depression effect became non-significant (p = .08). CONCLUSIONS: NRT improved cessation both among the depressed and non-depressed. To understand discrepancies in literature reporting depression and smoking cessation outcome, the pharmacological treatment modality and social-demographic variables should be examined as additional variables.

Exercise as an adjunct to nicotine gum in treating tobacco dependence among women.

This was the first randomized, controlled smoking cessation trial assessing the efficacy of an exercise intervention as an adjunct to nicotine gum therapy in comparison with both equal contact control and standard care control conditions. Sedentary female smokers aged 18-55 years were provided with nicotine gum treatment along with brief behavioral counseling and were randomized into one of these three behavioral adjunct conditions. In the "intent-to-treat" sample (N = 182), at end of treatment and at 1-year follow-up, there were clear, but nonsignificant, trends in univariate analyses in which the exercise and equal contact control conditions both had higher rates of abstinence than the standard care control. However, when adjusting for other predictors of relapse in a multiple logistic regression, both exercise and equal contact control showed an advantage over standard care control in avoiding early relapse (i.e., after 1 week). In a multivariate survival model adjusting for other predictors, the equal contact condition had a significantly lower likelihood of relapse compared with the standard care condition and there was a near significant trend in which exercise offered an advantage over standard care as well. While these findings suggest a slightly improved likelihood of abstinence with exercise compared with standard care, exercise did not differ from equal contact control in its efficacy. Potential explanations for these equivalent levels of efficacy and implications for the findings are discussed.

High-dose nicotine patch therapy for smokers with a history of alcohol dependence: 36-week outcomes.

This study reports findings from an investigation of the efficacy of high-dose nicotine patch (NP) therapy for heavy smokers with a history of alcohol dependence. One hundred thirty participants were randomly assigned to 42 or 21 mg of transdermal nicotine. Follow-up assessments were conducted at 4, 12, 24, and 36 weeks. Differences between dose conditions were nonsignificant, although, unexpectedly, outcomes favored participants in the 21-mg NP condition. Nicotine abstinence rates in the 21- and 42-mg NP conditions on Week 36 follow-up were 16.9% and 9.2%, respectively. Patch condition did not interact with severity of nicotine dependence. However, nicotine abstinence at follow-up was related to a longer length of alcohol abstinence. No evidence was found for better outcomes as a function of the percentage of baseline cotinine replaced by NPs. Future research should focus primarily on investigating ways to improve smoking quit rates for smokers in early alcohol recovery.

Depression and smoking across 25 years of the Normative Aging Study.

OBJECTIVE: The majority of past findings indicate that smokers are more likely than non-smokers to report depressive symptoms and that depression may act as an impediment to smoking cessation. The aim of the present study is to examine the stability of the relationship between depressive symptoms and smoking status and to determine whether the presence of depressive symptoms predicts continued smoking. METHODS: Subjects were initially healthy men (n = 2208) from the Veterans Administration Normative Aging Study, an ongoing cohort of older men who have been re-assessed every 3-5 years for a period of 25 years. Depressive symptoms measures employed were the Cornell Medical Index, the MMPI-2 Content Depression Scale, and the Center for Epidemiological Studies Depression Scale. RESULTS: Depression scores were higher among continuing smokers compared to never and former smokers and those who quit after entering the study. None of the three depressive symptoms measures were associated with decreased likelihood of smoking cessation. The change in MMPI-2 depression scores observed in a 4-year follow-up was the same among those who quit and those who remained smokers. CONCLUSIONS: Higher prevalence of depressive symptoms among male smokers is stable across time and is likely to contribute to higher morbidity and mortality among these smokers. However, presence of depressive symptoms did not have a significant impact on smoking cessation.

Impact of Nicotine Replacement Therapy on post-cessation mood profile by pre-cessation depressive symptoms.

We evaluated the effects of Nicotine Replacement Therapy (NRT) on the Profile of Mood States (POMS), testing whether pre-cessation depressive symptoms modify NRT's effects on POMS. Out of 608 smokers attempting to quit with NRT, this secondary analysis included 242 participants abstinent for at least two weeks. We measured pre-cessation depressive symptoms with the Center for Epidemiological Studies Depression Scale. At 1, 7, and 14 post-cessation days we examined 6 self-reported POMS, i.e. feeling 'anxious', 'sad', 'confused', 'angry', 'energetic' and 'fatigue'. The results of the ANCOVA models suggested no NRT effects on feeling anxious, energetic or fatigue. We found that pre-cessation depression modified NRT effects in some specific mood states, such as depression by NRT- interaction effects on feeling confused and feeling angry. On average, the depressed participants in the placebo groups had the highest symptom scores. However, those depressed in NRT conditions did not have significantly higher symptom scores compared to the non-depressed groups. In treating those negative moods NRT may be particularly important for persons with depressive symptoms before cessation.

Attrition in a multi-component smoking cessation study for females.

Limiting attrition (i.e., participant dropout before the conclusion of a study) is a major challenge faced by researchers when implementing clinical trials. Data from a smoking cessation trial for females (N = 246) were analyzed in order to identify baseline smoking-related, demographic and psychological characteristics affecting likelihood of early (i.e., before the quit attempt) and late (i.e., after the quit attempt) dropout. There were a number of significant demographic predictors of attrition. Participants with at least one child living at home were at increased risk of both early and late dropout. Non-Whites were at increased risk of early dropout, while not having a college degree put one at increased risk of late dropout. Age was found to be a protective factor in that the older a participant was, the less likely she was to drop out in the early stages of the trial. With respect to psychological variables, weight concerns increased risk of attrition, as did the experience of guilt. In terms of smoking-related variables, mean cigarettes per day was not a significant predictor of attrition, although length of longest prior quit attempt was a significant predictor of early dropout when age was removed from the regression.

The influence of gender, race, and menthol content on tobacco exposure measures.

Research has suggested that race, gender, and menthol cigarette use influence tobacco-smoke exposure measures and smoking-related disease risk. For example, a high proportion of Black smokers prefer menthol cigarettes and, despite smoking fewer cigarettes per day (CPD) than do Whites, tend to have higher cotinine levels. Additionally, Black males are more at risk for smoking-related lung cancer. High cotinine levels and smoking menthol cigarettes may lead to higher toxin intake, which contributes to increased disease risk. We explored the relationship between tobacco exposure variables (i.e., cotinine, CPD, carbon monoxide [CO], nicotine content, and nicotine dependence) with respect to race, gender, and menthol content in a sample of 307 smokers recruited from the greater Boston area to participate in a smoking cessation treatment trial. The pattern of correlations between tobacco exposure measures and cotinine showed a consistently positive correlation between cotinine and CO in all smokers and a correlation between cotinine and CPD in those who smoked nonmenthol cigarettes. Cotinine and CPD correlations varied by gender and race among menthol cigarette smokers. Consistently, we found a significant gender x race x menthol interaction on salivary cotinine level as well as cotinine/CPD ratio. These findings suggest that the relationship between number of cigarettes consumed and salivary cotinine is more complex than previously believed. It is not sufficient to look at race alone; researchers and clinicians need to look at race and gender concurrently, as well as type of cigarette consumed.

Cardiovascular risk behavior among sedentary female smokers and smoking cessation outcomes.

BACKGROUND: We examined female sedentary smokers' additional cardiovascular disease (CVD) risk behaviors and their associations to smoking cessation. METHODS: This study was part of a randomized controlled trial testing the effectiveness of exercise and nicotine gum in smoking cessation. Included in the analyses were 148 participants. Dietary habits and alcohol consumption were measured as additional CVD risk behaviors. High-fat diet and heavy alcohol use were considered those risk behaviors. Nicotine dependence, length of the longest quit attempt, depressive symptoms, self-efficacy, and education were examined as other baseline variables. Abstinence from tobacco was recorded through 12 months. RESULTS: Diet was related to depressive symptoms at baseline. Alcohol use was related to nicotine dependence and education level. Heavy alcohol use alone and accumulation of two added risk behaviors predicted poorer smoking cessation outcome. Although diet alone was not associated with cessation outcome the high-fat diet interacted with depressive symptoms, such that the depressed women with high-fat diet were significantly more likely to relapse in their quit attempt compared to other subgroups. CONCLUSION: Non-moderate alcohol use alone and accumulation of multiple CVD risk behaviors seem to be associated with lower success in smoking cessation.

Smoking relapse after 2 years of abstinence: findings from the VA Normative Aging Study.

Little is known about the risk of cigarette smoking relapse after 2 or more years of abstinence. The rates and predictors of late smoking relapse were estimated in 483 men who participated in a prospective study for up to 35 years. Subjects are participants in the VA Normative Aging Study, a prospective observational study of aging in men that began in 1963. Subjects are evaluated approximately every 3 years with physical examinations and questionnaires. Smoking, alcohol use, caffeine consumption, and socioeconomic variables were obtained by questionnaire, and weight and height were measured at clinical examinations every 3 years since 1963. Predictors of smoking relapse were identified using proportional hazards regression models. The rate of smoking relapse in the 2nd-6th years of abstinence fluctuated between 2 and 4% per year, and fell to less than 1% only after 10 years of abstinence. In multivariate regression models, coffee and alcohol consumption, and use of cigars or pipes significantly increased the risk of smoking relapse. A small risk of smoking relapse remains for at least 10 years after smoking cessation. Use of other tobacco products, coffee and alcohol increased the risk of late relapse. These findings may be useful in identifying those at highest risk for late relapse and for motivating former smokers to continue long-term abstinence.