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.     

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.     

Association of post-treatment smoking change with future smoking and cessation efforts among adolescents with psychiatric comorbidity.

Little is known about how initial change following a smoking intervention relates to longer-term smoking outcomes among adolescent smokers with psychiatric comorbidity. The present study investigated this relationship among psychiatrically hospitalized adolescents (N = 183) who participated in a controlled trial comparing motivational interviewing to brief advice. Quit attempters (n = 37), reducers (n = 45), and maintainers (n = 101) were assembled based on, respectively, having made a quit attempt, having reduced smoking by at least 50%, and having reduced smoking by less than 50% in the first week after hospital discharge. Hierarchical linear models and generalized estimating equations were conducted to test group differences in average number of cigarettes per smoking day and odds of making a quit attempt during subsequent weeks of a 12-month continuous follow-up, and in cotinine-verified abstinence rates at 1, 6, and 12 months posthospitalization. Baseline smoking levels and presence of a substance use disorder or anxiety disorder were predictive of outcomes. After controlling for covariates, we found that quit attempters smoked less during follow-up than did the other change groups and that reducers smoked less than maintainers. Quit attempters evidenced a higher percentage of quit attempts during follow-up than did the other change groups. Reducers had a greater average percentage of quit attempts during follow-up than did maintainers. However, groups did not differ on cotinine-verified abstinence rates across the follow-up period. Findings have implications for initial post-treatment change as it relates to subsequent smoking and cessation outcomes among adolescent smokers at especially high risk for smoking persistence.     

Homelessness and smoking cessation: insights from focus groups.

Smoking prevalence among homeless persons is approximately 70%, yet little is known about tobacco use patterns or smoking cessation practices in this population. We assessed smoking attitudes and behaviors, psychosocial and environmental influences on smoking, barriers to and interest in quitting, and preferred methods for cessation among some homeless smokers. Six 90-min focus groups of current smokers (N = 62) were conducted at homeless service facilities. Participants had a mean age of 41.5 years (SD = 9.3), were predominantly male (69.4%) and African American (59%), and smoked an average of 18.3 cigarettes/day. Although most reported that they were motivated to quit, a number of barriers to quitting were identified. Participants reported that the pervasiveness and social acceptance of tobacco use in homeless settings contributed to smoking more cigarettes per day, adopting alternative smoking behaviors such as smoking cigarette butts and making their own cigarettes, and experiencing difficulty in quitting. High levels of boredom and stress also were cited as reasons for continued smoking. Smoking frequently occurred in combination with alcohol or illicit drug use or to achieve a substitute "high." Most participants (76%) reported that they planned to quit smoking in the next 6 months. Many were interested in using pharmacotherapy in combination with behavioral treatments. Results suggest that, although motivated to quit smoking, homeless smokers are faced with unique social and environmental barriers that make quitting more difficult. Interventions must be flexible and innovative to address the unique needs of homeless smokers. Smoking restrictions at homeless service facilities and funding for smoking cessation assistance in this underserved population may help to reduce prevalence.     

Hypnosis for smoking cessation: a randomized trial

The purpose of this study was to determine whether hypnosis would be more effective in helping smokers quit than standard behavioral counseling when both interventions are combined with nicotine patches (NP). A total of 286 current smokers were enrolled in a randomized controlled smoking cessation trial at the San Francisco Veterans Affairs Medical Center. Participants in both treatment conditions were seen for two 60-min sessions, and received three follow-up phone calls and 2 months of NP. At 6 months, 29% of the hypnosis group reported 7-day point-prevalence abstinence compared with 23% of the behavioral counseling group (relative risk [RR] = 1.27; 95% confidence interval, CI 0.84-1.92). Based on biochemical or proxy confirmation, 26% of the participants in the hypnosis group were abstinent at 6 months compared with 18% of the behavioral group (RR = 1.44; 95% CI 0.91-2.30). At 12 months, the self-reported 7-day point-prevalence quit rate was 24% for the hypnosis group and 16% for the behavioral group (RR = 1.47; 95% CI 0.90-2.40). Based on biochemical or proxy confirmation, 20% of the participants in the hypnosis group were abstinent at 12 months compared with 14% of the behavioral group (RR = 1.40; 95% CI 0.81-2.42). Among participants with a history of depression, hypnosis yielded significantly higher validated point-prevalence quit rates at 6 and 12 months than standard treatment. It was concluded that hypnosis combined with NP compares favorably with standard behavioral counseling in generating long-term 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.     

Smoking during the night: prevalence and smoker characteristics.

We report on the smoking patterns and characteristics of individuals who smoke at night. We also explore the relationship between night smoking, nicotine dependence, and cessation outcomes. Participants (N = 691) were heavy smokers enrolled in cessation research clinics. Data were from three studies. Using ecological momentary assessment, participants monitored their smoking (ad libitum, day and night) on electronic diaries (EDs) during a 2-week baseline period and for 4 weeks following a target quit day. A total of 41% of smokers recorded at least one episode of night smoking. Within this group, night smoking occurred on 26% of nights, averaging two episodes per night. ED data correlated with a single self-report item assessing the frequency of night smoking. Night smoking was associated with greater nicotine dependence and daily caffeine consumption. It also predicted risk for lapsing beyond traditional measures of nicotine dependence. Night smoking is common, is associated with nicotine dependence, and it represents additional risk for cessation failure. People who smoke at night may need nicotine replacement therapy overnight. Future research should determine whether treatments that improve sleep quality also improve cessation outcomes in night smokers.     

A randomized trial of nicotine replacement therapy in combination with reduced-nicotine cigarettes for smoking cessation

A randomized double-blind, active controlled, parallel group, multi-center phase II clinical trial was conducted to evaluate the efficacy of reduced-nicotine cigarettes as a novel smoking cessation treatment (under Investigational Device Exemption 69,185). The concept for a reduced-nicotine cigarette designed to progressively wean smokers from the smoking habit is based on research demonstrating that successful smoking cessation is not only dependent on withdrawal of nicotine, but also on weaning from the habitual sensory and behavioral reinforcement of smoking. Treatment consisted of Quest brand of cigarettes (Quest 1, 2, and 3), which respectively deliver 0.59+/-0.06, 0.3+/-0.05, and less than 0.05 mg nicotine, either alone or in combination with nicotine replacement therapy (NRT). The primary endpoint was 4 weeks of continuous abstinence (Weeks 7-10), with additional follow-up at 3 and 6 months. Adult men and women smokers (N = 346), motivated to quit, were randomized to one of three treatment groups: Quest plus NRT (NRT pretreatment 2 weeks before, and NRT after the quit date), Quest plus placebo patch, or active control plus NRT (conventional cigarette, followed by NRT after quit date). Results showed that Quest plus NRT was more effective than active control plus NRT in achieving 4 weeks of continuous abstinence (32.8% vs. 21.9%). Quest plus placebo patch yielded an abstinence rate similar to that of the active control plus NRT (16.4% vs. 21.9%). No serious adverse events were attributable to the investigational product. Quest plus NRT offers promise as a new smoking cessation treatment.     

Dimensions of depressive symptoms and smoking cessation.

Because different psychopathologic components of depressive symptoms may have distinct etiologies, examining their differential effects on smoking cessation may elucidate mechanisms underlying the smoking-depression relationship. Negative affect (NA), somatic features (SF), low positive affect/anhedonia (PA), and interpersonal disturbance (IP) have been identified as unique dimensions of depression that can be measured using the Center for Epidemiologic Studies Depression Scale (CESD). This study examined common and unique associations between CESD subscales and baseline smoking characteristics, nicotine withdrawal, and relapse in 157 participants enrolled in a smoking cessation trial for heavy social drinkers. Each dimension was univariately associated with negative and positive reinforcement smoking motives. Only SF had unique relations with tolerance smoking motives and univariate associations with nicotine dependence severity. Only PA predicted cessation-related changes in withdrawal symptoms on quit day. Analyses predicting abstinence at 8, 16, and 26 weeks post quit date showed that NA, SF, and PA each univariately predicted relapse, ps< or =.0083. Only low PA predicted poorer outcomes incrementally to the other dimensions, even when controlling for level of nicotine dependence, smoking frequency, and history of major depression, p = .0018. Interventions targeting anhedonia and low positive affect may be useful for smokers trying to quit.     

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.     

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.     

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.     

The impact of carotid plaque screening on motivation for smoking cessation.

Showing smokers their own atherosclerotic plaques might increase motivation for smoking cessation, since they underestimate their own risk for smoking-related diseases. To assess the feasibility and optimal processes of studying the impact of carotid atherosclerotic plaque screening in smokers, we enrolled 30 daily cigarette smokers, aged 40-70 years, in an observational pre-post pilot study. All smokers underwent smoking cessation counseling, nicotine replacement therapy, a carotid ultrasound, an educational tutorial on atherosclerosis, baseline and 2-month motivation to change assessment, and assessment of smoking cessation at 2 months. Participants had a mean smoking duration of 34 years (SD = 7). Carotid plaques were present in 22 smokers (73%). Between baseline and 2 months after plaque screening, motivation for smoking cessation increased from 7.4 to 8.4 out of 10 (p = .02), particularly in those with plaques (7.2 to 8.7, p = .008). At 2 months, the smoking quit rate was 63%, with a quit rate of 73% in those with plaques vs. 38% in those without plaques (p = .10). Perceived stress, anxiety, and depression did not increase after screening. 96% of respondents answered correctly at least 80% of questions regarding atherosclerosis knowledge at baseline and after 2 months. In conclusion, studying the process of screening for carotid plaques for the purpose of increasing motivation for smoking cessation, in addition to counseling and drug therapy for smoking cessation in long-term smokers, appears feasible. The impact of carotid plaque screening on smoking cessation should be examined in larger randomized controlled trials with sufficient power to assess the impact on long-term smoking cessation rates.     

Designing smoking cessation services for school-age smokers: A survey and qualitative study.

To identify the preferred design characteristics of smoking cessation services for school-age smokers, we conducted focus groups with teenage smokers motivated to stop smoking. We surveyed all pupils in years 9-11 (aged 13-16) in a random sample of 10 schools in Nottinghamshire, United Kingdom, to elicit details of smoking behavior, and conducted 25 focus groups in 6 schools with current smokers who wanted to stop smoking. Of 4,065 pupils surveyed, 888 (22%) were current smokers, and 438 (50% of smokers) wanted to quit smoking. We sampled 226 of these individuals for focus group studies, and 135 (60%) participated. These participants were motivated to quit, and almost all had tried to do so but had found it too difficult. Many were aware of smoking cessation methods but had low perceptions of their effectiveness based on their own or others' poor experiences of these interventions, and few were aware of the possibility of professional cessation support. Given clear, nondirective information about interventions, participants reported a preference for confidential, nonjudgmental services delivered during school time by a trained counselor, allowed the option to attend with friends, and offered nicotine replacement therapy (NRT). School-age smokers in Nottinghamshire, United Kingdom, who are motivated to stop smoking have low knowledge and opinions of smoking cessation interventions. Our findings indicate that young smokers would favor school-based services offering confidential professional counseling and NRT.     

Feasibility, cost, and cost-effectiveness of a telephone-based motivational intervention for underserved pregnant smokers.

This study reports on the evaluation of the feasibility, cost, and cost-effectiveness of a proactively provided telephone-based motivational smoking cessation intervention to an underserved population of pregnant smokers who may or may not receive ongoing prenatal care. As part of the New England SCRIPT randomized clinical trial comparing the efficacy of three types of smoking cessation interventions for pregnant smokers, one-third of the women (n = 358) received a motivational telephone counseling intervention (MI) delivered by trained counselors using a semistructured protocol. Although this population was very mobile, the MI counselors were able to reach 86% of the women with at least one call and 46% received all three calls. The group receiving three MI calls had a cotinine-confirmed quit rate of 23%. Cost-effectiveness analyses for those women receiving telephone counseling supported the net benefit in favor of the three phone calls compared with the women who did not receive any telephone calls, with an effectiveness to cost ratio of 1:US dollars 84. Our results suggest that telephone-based motivational smoking cessation counseling may be a feasible and cost-effective method for low-income pregnant smokers enrolled in prenatal care.     

Increase in common cold symptoms and mouth ulcers following smoking cessation

Design: Smokers were assessed one week before stopping smoking (baseline), then after one, two, and six weeks of smoking abstinence.

Participants: 174 smokers attending a seven week smoking cessation programme combining behavioural support with nicotine patches.

Main outcome measures: Self reports of cold symptoms, mouth ulcers, and smoking abstinence (validated using expired carbon monoxide) were recorded on each measurement occasion.

Results: Following one, two, and six weeks of smoking abstinence 73.0% (127/174), 57.5% (100/174), and 44.8% (78/174) of the participants, respectively, maintained continuous abstinence and provided reports of cold symptoms and mouth ulcers. For those abstinent from smoking for six weeks, relative to baseline, a significant increase in reports of the number of cold symptoms was observed following one and two weeks of smoking abstinence (p = 0.009 and p = 0.038, respectively) and an increase in reports of mouth ulcers after one and two weeks of abstinence (p = 0.004 and p = 0.008, respectively). Following one week of abstinence significant increases in reports of sore throat, coughing, deafness, and sneezing were observed (p = 0.049, p < 0.001, p< 0.039, and p < 0.003, respectively).

Conclusions: This is the first study to systematically document significant increases in cold symptoms and mouth ulcers following smoking cessation. Smokers should be informed that they have an increased chance of experiencing these symptoms on stopping smoking. Being psychologically prepared for these effects may reduce their impact on the attempt to stop smoking.

     

Nicotine lozenges for the treatment of smokeless tobacco use.

Nicotine lozenges have been shown to increase tobacco abstinence rates in cigarette smokers, but they have not been evaluated in smokeless tobacco (ST) users. We conducted an open-label, one-arm, phase II clinical trial to evaluate the efficacy of the 4-mg nicotine lozenge for the treatment of withdrawal and craving associated with tobacco abstinence among ST users. Eligible subjects received 4-mg nicotine lozenges for 6 weeks followed by a 6-week taper. Subjects completed daily tobacco withdrawal diaries, and data on lozenge use, adverse events, and lozenge acceptability were collected. Urine anabasine was collected at 3 and 6 months for biochemical confirmation of self-reported tobacco abstinence. Participants were 30 ST users with a mean age of 35.4 years (SD=6.5) using an average of 4.2 cans or pouches (SD=3.2) of ST per week for a mean of 15.1 years (SD=6.5). Among subjects continuously tobacco abstinent for the first 2 weeks, no significant increases in composite withdrawal symptoms were observed, compared with baseline symptoms, whereas craving decreased significantly. Biochemically confirmed 7-day point-prevalence tobacco abstinence was 53% (95% CI=34%-72%) at 12 weeks (end of treatment) and 47% (95% CI=28%-66%) at 6 months. Few adverse events attributable to the nicotine lozenge occurred, and the lozenge was perceived as helpful in assisting subjects quit ST. The use of the 4-mg nicotine lozenge appears promising for the clinical treatment of withdrawal symptoms and craving associated with tobacco abstinence in ST users. Future phase III clinical trials investigating the efficacy of nicotine lozenges are warranted.     

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.