Treating smokers before the quit date: can nicotine patches and denicotinized cigarettes reduce cravings?

The present study investigated whether treatment with the combination of denicotinized cigarettes and 21-mg nicotine patch for 2 weeks before a designated quit date could lessen cravings for smoking, thereby helping smokers abstain from smoking. The study was a randomized controlled clinical trial conducted at Roswell Park Cancer Institute, Buffalo, New York, in 2004 and 2005. Patients included 98 adult heavy smokers (using 20 or more cigarettes/day). Half of the subjects received 2 weeks of combination of denicotinized cigarettes (Quest 3) and 21-mg nicotine patch for 2 weeks before the quit date. The remaining smokers were switched to light cigarettes (Quest 1) during the 2 weeks before the quit date. After the quit date, all subjects received counseling for smoking cessation and were provided nicotine patches for up to 8 weeks after the quit date. Self-reported cravings for smoking, withdrawal symptoms, and smoking abstinence were measured at predetermined intervals using phone-based surveys and in clinical visits. The group that used denicotinized cigarettes and nicotine patch before quitting reported less frequent and less intense cravings for cigarettes in the 2 weeks before and after the designated quit date. Self-reported withdrawal symptoms and quit rates did not differ significantly between the groups. The use of a denicotinized cigarette combined with the nicotine patch appears to lessen cravings to smoke in the immediate postcessation period. A larger, better-powered study is needed to test if this treatment combination has merit for increasing quit rates.     

Transdermal nicotine use in postmenopausal women: does the treatment efficacy differ in women using and not using hormone replacement therapy?

This study of postmenopausal female smokers (N = 94) asked: During short-term smoking abstinence, do the beneficial effects of transdermal nicotine replacement therapy (NRT) on acute symptomatology (i.e., withdrawal, cigarette craving, smoking urges, mood, depressive symptoms, motor speed, and reaction time) differ in women who use and do not use hormone replacement therapy (HRT)? Participants were recruited according to HRT and non-HRT use (self-selecting), then randomized within strata to active nicotine or placebo nicotine patch. After 1 baseline week of smoking, participants quit smoking for 2 weeks. Women received cessation counseling and were monitored for abstinence. Dependent measures were collected during five clinic visits. Two-way analysis of covariance (ANCOVA) were run on change scores for dependent variables, with nicotine patch group (active/placebo) and HRT group (HRT/non-HRT) as independent variables and age as a covariate. No interactions were found between HRT and patch condition, but both showed specific effects. During the first abstinent week, women on active nicotine patch (compared with placebo) experienced less severe withdrawal, greater reductions in cigarette cravings, and lower (more favorable) Factor 1 scores on the Questionnaire of Smoking Urges. During the second abstinent week, women using HRT (compared with the non-HRT group) exhibited better mood (Profile of Mood States scores) and less depression (Beck Depression Inventory scores). These results suggest the following: First, the efficacy of transdermal nicotine replacement is not adversely modified by women's HRT use; second, ovarian hormones might influence women's responses to smoking cessation, and thus should be considered in developing effective strategies for women to quit smoking.     

Expressive writing as a smoking cessation treatment adjunct for young adult smokers.

This investigation evaluated the efficacy of expressive writing as a treatment adjunct to a brief office smoking cessation intervention plus nicotine patch therapy in young adults. Participants aged 18-24 years were randomized to a brief office intervention (n=99) or to an expressive writing plus brief office intervention (n=97). Both conditions received four individual visits plus 6 weeks of nicotine patch therapy, which began on the quit date following the week 2 visit. Participants in the expressive writing plus brief intervention condition wrote for 2 consecutive days before and 3 consecutive days after the quit date. The brief office intervention group completed a control writing assignment. At end of treatment (week 8), biochemically confirmed 7-day point-prevalence abstinence for the expressive writing plus brief office intervention condition was significantly greater than for the brief office condition (33% vs. 20%, p=.043, OR=2.0, 95% CI=1.0-3.7, from a logistic regression adjusting for gender). At 24 and 52 weeks, abstinence rates were similar for the brief office intervention versus expressive writing plus brief office intervention (12% vs. 11% at 24 weeks; 11% vs. 11% at 52 weeks). The results suggest that expressive writing has promise as a smoking cessation treatment adjunct for young adults. Lengthier interventions or the use of boosters should be tested to extend treatment effects. However, participants reported a low level of enthusiasm for the expressive writing, which may be a barrier to implementing it over a longer time frame. Therefore, other modes of delivering expressive writing to young adult cigarette smokers should be explored.     

Smokers' expectancies for nicotine replacement therapy vs. cigarettes.

Smokers (N=188) recruited from the local community completed a questionnaire that measured expected outcomes of using cigarettes, nicotine gum, nicotine patch, and nicotine nasal spray. Expectancy questions relating to negative affect, craving, weight, and health risks were derived from the Smoking Consequences Questionnaire-Adult. As predicted, smokers held much greater expectancies that cigarettes help control negative affect, craving, and weight relative to nicotine replacement therapy (NRT). All NRT products were expected to cause fewer health risks than cigarette smoking. As predicted, smokers held strong negative affect reduction expectancies for cigarette smoking. For NRT, although still relatively low, craving reduction was the strongest expectancy. Individuals who had experience using the nicotine patch had greater positive expectancies for NRT. Greater positive expectancies for NRT were correlated with more immediate plans to quit smoking. In summary, cigarette smokers' positive expectancies about cigarettes do not appear to generalize to NRT products, which may limit their use and effectiveness.     

Menthol cigarettes and smoking cessation during an aided quit attempt.

Menthol may make cigarettes more addictive and rates of menthol cigarette smoking are disproportionately higher among Black. However, few studies have examined the association between menthol cigarette smoking and cessation, and the studies to date have produced conflicting findings. The present study examines the effect of menthol cigarette smoking on cessation among a multi-ethnic sample of smokers making a pharmacotherapy-aided quit attempt. We hypothesized that menthol cigarette smoking would be associated with lower smoking abstinence rates and conducted a secondary analysis of data from a multi-site randomized controlled trial of an intervention designed to facilitate repeat tobacco cessation treatment (N = 1,343). The intervention consisted of a patient phone call and a computerized provider prompt. The primary outcome for this analysis was 7-day point prevalence smoking abstinence. The average age of the sample was 56 years old. Overall, 25% of the sample smoked menthol cigarettes: 19% of Whites, 62% of Blacks, and 25% of other ethnicity (p<.001). We observed no significant effects for menthol cigarette smoking or ethnicity on smoking abstinence rates. In conclusion, combined with findings from previous research, this study suggests that smoking menthol cigarettes does not decrease smoking cessation among older smokers during a quit attempt aided with pharmacotherapy.     

Smoking cessation patterns in methadone-maintained smokers.

To determine predictors of smoking cessation duration in a randomized clinical trial, we assigned participants to nicotine patch (8-12 weeks) plus either (a) a baseline tailored brief motivational intervention, a quit date behavioral skills counseling session, and a relapse prevention follow-up session, or (b) brief advice using the National Cancer Institute's 4A's model. A total of 383 smokers from five methadone maintenance treatment centers in Rhode Island were enrolled, of whom 312 (82%) completed 6-month follow-up assessments. The primary outcome was longest period of self-reported abstinence during follow-up. Participants were on average 40.5 years of age; 51.9% were male, and 77.6% were White. In multivariate analysis controlling for demographics, nicotine dependence, depressive symptoms, and smoking-related symptoms, we found longer periods of abstinence in persons reporting at least one 24-hr quit attempt in the year prior to baseline (OR = 1.97, p = .003), in those anticipating success in cessation (OR = 1.33, p = .024), and in those with a greater percentage of nicotine patch use days (OR = 2.78, p<.001). Past quit attempts, self-efficacy, and constant nicotine replacement were associated with duration of abstinence among methadone-maintained smokers. Attention to these domains in future intervention studies may improve treatment success.     

Cough following initiation of smoking abstinence.

Some clinicians and patients believe that cough and sputum production may transiently increase over the first weeks after smoking cessation and may in fact represent a barrier to successful quitting. The present study described changes in cough after an attempt to quit smoking cigarettes and determined patients' perceptions of how changes in cough affected their ability to maintain abstinence from smoking. Daily smokers already recruited for ongoing outpatient clinical trials of pharmacological aids to quit cigarette smoking were invited to complete self-report questionnaires about their cough for up to 6 weeks after their target quit date (TQD). Of the 176 subjects invited to participate, 112 completed the first assessment after the TQD. Of these, a total of 45 subjects maintained at least 1week of smoking abstinence at some point in the 6-week period (confirmed by carbon monoxide measurements). Two self-report measures found that cough declined steadily in abstinent smokers but was constant in a comparator group of continuing smokers (n = 36). For the 94 subjects who reported smoking at least one cigarette following the TQD, few reported that changes in cough affected their abstinence attempt. For three items asking about this area, the upper 95% confidence interval was no more than 10% for agreement that changes in cough posed any barrier to abstinence. We conclude that an initial increase in cough is unlikely to occur among relatively healthy smokers who stop smoking and that changes in cough do not represent a barrier to maintaining abstinence for most smokers.     

Smoking reduction in the Lung Health Study.

We examined the ability of smokers who failed to quit smoking in the Lung Health Study to reduce the number of cigarettes per day and maintain this reduction and whether reduction predicted increased or decreased future cessation. In the Lung Health Study, among smokers with early lung disease who wished to stop smoking, 3923 were randomized to a special intervention of counseling and nicotine gum for smoking cessation and to bronchodilator therapy or placebo. Among the 1722 who were still smoking at the first year follow-up, 27% smoked the same, 43% smoked 1%-49% fewer, and 30% smoked at least 50% fewer cigarettes per day. Reduction in cigarettes per day was accompanied by reduction in expired-air carbon monoxide. About half of the less-than-50% reducers and one-fifth of the at-least-50% reducers maintained or exceeded this reduction over the next 4 years. Reduction was associated with nicotine gum use. Greater reduction at year 1 predicted more quit attempts in year 2 but not more point prevalence abstinence at year 2 nor more quits or abstinence between years 2 and 5. We conclude that reduction can be maintained but such reduction neither predicts an increased nor decreased probability of future cessation.     

The serotonin transporter 5-HTTLPR polymorphism and treatment response to nicotine patch: follow-up of a randomized controlled trial.

In this follow-up of a randomized placebo-controlled clinical trial of nicotine replacement transdermal patch for smoking cessation, 741 smokers of European ancestry who were randomized to receive active patch or placebo patch were genotyped for the serotonin transporter gene-linked polymorphic region. The study setting was a primary care research network in Oxfordshire, United Kingdom. The primary outcome measures were biochemically verified sustained abstinence from cigarette smoking at end of treatment and 24-week follow-up. The main effect of genotype was not associated with sustained abstinence from smoking at either end of treatment (SL: p=.33; SS: p=.81) or 24-week follow-up (SL: p=.05; SS: p=.21), and we found no evidence for a genotypextreatment interaction effect. In summary, despite the theoretically important contribution of serotonin neurotransmission to smoking cessation, the serotonin transporter gene was not associated with treatment response to nicotine patch for smoking cessation in this primary care-based trial.     

Smoking cessation in homeless populations: a pilot clinical trial.

This study, which tested two motivational interviewing treatment approaches, assessed the feasibility of conducting a community-based smoking cessation intervention among homeless smokers. Participants (N = 46) were recruited from multiple facilities in the Kansas City area and were randomized to two counseling conditions in which they received five individual motivational interviewing sessions, six group meetings, and their choice of 8 weeks of 21-mg nicotine patch or 4-mg nicotine lozenge. The two counseling conditions consisted of motivational interviewing targeted either to smoking behaviors exclusively (smoking only) or to smoking and other addictions or life events that could affect ability to quit (smoking plus). Group meetings were designed to provide educational information and social support. Measures of feasibility assessed included the proportion of participants who returned for randomization among those eligible, adherence to prescribed nicotine replacement therapies, retention rates at the week 26 final study visit, and biochemically verified 7-day abstinence at week 26. Most participants (69.6%) chose nicotine patches, and 32% of those participants reported using at least four patches per week. Carbon monoxide verified 7-day abstinence rates in the smoking-only and smoking-plus groups were 13.04% and 17.39% (ns), respectively, at week 8 and 8.70% and 17.39% (ns), respectively, at week 26. Participants who used at least four patches per week were more likely to have quit at 8 weeks than were those who used fewer patches (33.3% vs. 10.5%, p = .30). Results support the feasibility of conducting a smoking cessation intervention among homeless smokers. Findings also show promising effects for nicotine replacement therapy and counseling in this population. Developing programs to improve smoking cessation outcomes in underserved populations is an essential step toward achieving national health objectives and for ultimately reducing tobacco-related health disparities.     

Efficacy of naltrexone in smoking cessation: a preliminary study and an examination of sex differences.

This double-blinded, placebo-controlled trial evaluated the efficacy of naltrexone as an adjunct to standard smoking cessation treatment. Participants (N = 110) were adult male and female nicotine-dependent smokers who expressed interest in quitting smoking. All subjects received six sessions of behavioral counseling (1 hr/session for 6 weeks), and 1 month of the nicotine patch (21 mg for the first 2 weeks, 14 mg the third week, 7 mg the fourth week). Subjects were randomly assigned to the naltrexone or placebo group. The naltrexone group started at 25 mg daily for 3 days prior to the quit date, and increased to 50 mg/day on the quit date and following 8 weeks. At the end of medication treatment, the naltrexone group had better quit rates versus the placebo group (48% quit on naltrexone vs. 41% on placebo), but this difference was not statistically significant. However, men and women differed on several measures: in the placebo group, women had significantly lower quit rates than men (39% vs. 67%, p<.05), but in the naltrexone group, women had quit rates comparable with those of men (58% vs. 62%, p = ns). Further examination revealed that naltrexone significantly reduced men's and women's cessation-related weight gain and selectively reduced women's urge to smoke to relieve negative affect and withdrawal. The results suggest continued examination of naltrexone as an adjunct in smoking cessation, particularly in female smokers, who have historically shown worse outcomes with traditional treatment methods.     

Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial.

Many smokers are not ready to quit but are interested in changing their smoking behavior, particularly if such a change is associated with a reduction in health risk. The present study evaluated the efficacy of the nicotine inhaler in reducing smoking. Exploratory studies assessed whether reduction in smoking was associated with reduction in markers of disease risk. A total of 429 healthy smokers (smoking at least 20 cigarettes/day) were randomly assigned to either nicotine-containing or placebo inhalers, which subjects were allowed to use ad libitum for up to 1 year. The nicotine inhaler was significantly superior to placebo in achieving reduction in daily cigarette consumption by at least 50% after 4 months, compared with baseline (18% vs. 8%, p = .004). Active treatment promoted smoking cessation: 8% of subjects in the nicotine group and 1% in the placebo group were abstinent at month 15. Throughout the study, smoking reduction, per se, independent of treatment group, was associated with a statistically significant decrease in exhaled carbon monoxide and serum cotinine and thiocyanate. Smoking reduction also improved established risk markers for cardiovascular disease over 4 months. The incidence of adverse events did not differ significantly between the active and placebo groups. The most common treatment-related adverse events were throat irritation and cough. In conclusion, the nicotine inhaler can help smokers who are unable or unwilling to quit to reduce daily cigarette consumption, which may be a health benefit on its own and may further promote quitting.     

Smokers' interest in using nicotine replacement to aid smoking reduction.

In recent years the public health community has considered the risks and benefits of encouraging smokers to reduce their smoking, perhaps with the aid of nicotine replacement therapy (NRT). Little is known, however, about whether smokers themselves are interested in smoking reduction; whether they see reduction as an endpoint, or primarily as a route to cessation; or whether they are receptive to the notion of using NRT to achieve reduction. We conducted a population-based national telephone survey of 1,000 current daily cigarette smokers (499 male, 501 female). Most smokers (57%) reported previously trying to reduce their smoking, and many (26%) said that they plan to reduce within the next year. Almost half of those planning to quit in the next 12 months (44%) preferred to quit via gradual cessation and most (68%) indicated that they would consider using a reduction product or medication. Respondents reported that they would prefer a product with a cessation endpoint rather than a reduction endpoint (63% vs. 21%). Interest in reduction was highest among smokers who were less interested in quitting and among heavier smokers. We conclude that many smokers are interested in gradually reducing prior to quitting and that promoting reduction is unlikely to undermine motivation to quit smoking.     

Is Swedish snus associated with smoking initiation or smoking cessation?

Nicotine replacement therapies (NRT) are an effective treatment for tobacco dependence, yet most smokers do not quit or remain abstinent. We investigated whether Swedish snus (snuff) use was associated with smoking cessation among males participating in a large population based twin study in Sweden. Snus use was associated with smoking cessation but not initiation. Given that snus delivers comparable nicotine concentrations but carries lesser cancer risk than cigarettes, snus may be a widely used, non-medical form of NRT. Evaluation of the efficacy of snus for smoking cessation should be evaluated in randomised clinical trials.     

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.     

Comparison of the effects of a 24-hour nicotine patch and a 16-hour nicotine patch on smoking urges and sleep.

This randomized, open-label, crossover study was conducted to compare the effects of a 24-hr nicotine patch and a 16-hr nicotine patch on morning smoking urges and sleep quality of dependent smokers during a short period of cigarette abstinence. A total of 20 smokers (9 women and 11 men) smoking at least 20 cigarettes/day completed the two smoke-free study periods. For each period, cigarette abstinence started on the first evening and a nicotine patch was applied the next morning (for 16 or 24 hr), after baseline measures; a second patch was applied the next morning, 1 hr before the end of the experimental period. Smoking urges, mood and behavior self-reports, psychomotor performance, and polysomnographic recordings were compared between the two types of nicotine patch according to changes from baseline. Both patches decreased morning smoking urges, although results were significantly superior for the 24-hr patch. Furthermore, the 24-hr patch was more effective than the 16-hr patch in reducing the positive reinforcing dimension of smoking urges. Regarding polysomnographic recordings, the proportion of slow wave sleep was significantly increased from baseline with the 24-hr patch compared with the 16-hr patch. As for psychomotor performance measured through the critical flicker fusion test, significant improvement in morning alertness was observed in the 24-hr patch group. In conclusion, the 24-hr nicotine patch formulation is more effective than the 16-hr formulation in alleviating morning smoking urges and more specifically the positive reinforcing factor. The present findings do not support the idea that nicotine delivery during bedtime might disturb sleep, but rather it improves restorative sleep and postwaking arousal.     

Sex differences in long-term smoking cessation rates due to nicotine patch

Compared to men, women may be at greater risk for smoking-related diseases and have greater difficulty quitting smoking. Sex differences in medication response could guide treatment for smoking cessation to improve women's quit rates. We conducted a meta-analysis of the 14 placebo-controlled nicotine patch trials (N = 6,250) for which long-term (6 months) clinical outcome results could be determined separately by sex. This analysis updated a meta-analysis of 11 of these trials that found no significant sex differences due to nicotine patch. The increase in quitting due to the nicotine vs. placebo patch was only about half as large in women as in men. Pooled absolute quit rates at 6 months for nicotine and placebo patch, respectively, were 20.1% and 10.8% in men, and 14.7% and 10.1% in women. The odds ratio for quitting due to nicotine vs. placebo patch was lower in women (OR = 1.61) than in men (OR = 2.20), with an interaction odds ratio of 1.40 (95% CI = 1.02-1.93, p = .04). This sex difference did not vary significantly by whether or not formal counseling was provided. Poorer outcomes in women vs. men treated with nicotine patch suggests that increasing the quit rates of women smokers may require supplementing patch treatment or use of other medications.     

Over-the-counter availability of nicotine replacement therapy and smoking cessation.

In 1996, the FDA approved over-the-counter (OTC) availability of nicotine gum and two brands of nicotine skin patches. Little is known about how this reclassification has influenced the effectiveness and use of nicotine replacement therapy (NRT) and whether it has been a public health benefit. Data for the present study came from a prospective cohort study of 1,639 adult smokers surveyed by telephone in 1993, as part of the National Cancer Institute's Community Intervention Trial for Smoking Cessation (COMMIT), and resurveyed in 2001. NRT-assisted quit rates, NRT use rates, and the characteristics of NRT users were calculated before and after the 1996 OTC reclassification. Also calculated was the percentage of NRT users who quit by year. Results are presented for patch and gum separately and combined. OTC NRT use rates were lower for Hispanics and higher for those with no desire to quit at baseline. The quit rate decreased for patch-assisted quit attempts after OTC reclassification (22.5% to 18.5%, p = .05), but it did not change for gum-assisted quit attempts (11.9% to 10.5%, p = .54). NRT use rates increased for both patch and gum by about 60% following reclassification. A greater percentage of gum users had quit in the post-OTC period than in the pre-OTC period (9.7% vs. 14.6%, p = .05). Long-term quit rates in patch users were similar in both periods. Insurance coverage of NRT and concurrent attendance in a stop smoking clinic decreased for both patch- and gum-assisted attempts in the post-OTC period. The results suggest that OTC reclassification may have contributed to the increased use of NRT, compared with the pre-OTC period, whereas the efficacy for quitting decreased slightly for those using nicotine patch and remained about the same for those using the gum.     

Use of nicotine replacement therapy in socioeconomically deprived young smokers: a community-based pilot randomised controlled trial

Background

Smoking is common in young people, particularly in disadvantaged groups, and continued smoking has a major impact on quality and quantity of life. Although many young smokers want to stop smoking, little is known about the design and effectiveness of cessation services for them.

Objective

To determine whether nicotine replacement therapy (NRT) when combined with counselling is effective in young smokers in a deprived area of Nottingham, UK

Methods and subjects

We surveyed smoking prevalence and attitudes to smoking and quitting in young people accessing an open access youth project in a deprived area of Nottingham, and used the information gained to design a community based smoking cessation service incorporating a randomised controlled trial of nicotine patches against placebo given in association with individual behavioural support. We resurveyed smoking prevalence among project attendees after completing the pilot study.

Results

Of 264 young people surveyed (median age 14 years, range 11–21), 49% were regular smokers. A total of 98 young people were recruited and randomised to receive either active nicotine patches on a six week reducing dose regimen (49 participants), or placebo (49 participants). Adherence to therapy was low, the median duration being one week, and 63 participants did not attend any follow up. At four weeks, five subjects receiving active NRT and two receiving placebo were abstinent, and at 13 weeks none were. Adverse effects were more common in the active group but none were serious. Smoking prevalence among 246 youth project attendees surveyed after the trial was 44%.

Conclusions

This study suggests that NRT in this context is unlikely to be effective in young smokers, not least because of low adherence to therapy. It also suggests that young smokers want help with smoking cessation, but that establishing the efficacy of smoking cessation services for young people who need them most will be very difficult.