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.     

Comparison of two self-help smoking cessation booklets

OBJECTIVE: To compare two self-help smoking cessation booklets distributed to callers to a Quitline telephone service in Queensland (Australia). DESIGN: Callers were randomised to receive either a structured 14-day quit programme (Time to quit) or another booklet and described four broad stages of quitting (Can quit). Approximately one month later, these callers were interviewed by telephone. MAIN OUTCOME MEASURES: Self-reported smoking status at one month and recent quit attempts together with process measures. RESULTS: Altogether, 521 callers (78.3%) were interviewed. They were heavier smokers when compared with all Queensland smokers: on average they had smoked for more than 15 years, smoked nearly 25 cigarettes per day, and almost two-thirds had attempted to quit smoking in the past year. In each group, significant proportions either did not begin to use the booklet (50.5-56.0%), or did not complete its use (77.4-82.3%). There were no differences in the self-reported quit rates at one month (17.0% vs 16.1%; p = 0.93). In an ordinal regression modelling procedure involving age, sex, number of recent quit attempts, number of cigarettes smoked per day, smoking status of partner, number of five closest friends who smoke, education, and booklet received, only the number of cigarettes smoked per day was significantly related to smoking status at one month. CONCLUSIONS: Callers to telephone Quit-line services are typically heavier smokers than the general smoking population, and simple strategies, such as self-help booklets, appear to achieve relatively high success. Nevertheless, there is potential to improve the effectiveness of these materials by making a range of materials available and encouraging callers to make a serious attempt to quit smoking.     

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.     

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.     

Gabapentin for smoking cessation: a preliminary investigation of efficacy.

Gabapentin affects the glutamate and gamma amino butyric acid (GABA) neurotransmitters through which it may facilitate smoking abstinence. To obtain preliminary estimates of efficacy of gabapentin for smoking cessation, we conducted a single-arm, open-label study of gabapentin, 1,800-mg/day administered in three equal divided doses for 8 weeks. A total of 50 adult smokers were enrolled. All participants received a brief behavioral intervention at each medication visit. A total of 37 participants completed all follow-up assessments. At end-of-treatment the biochemically confirmed point-prevalence and prolonged smoking abstinence rates were 28% (95% CI=16%-42%) and 24% (95% CI=13%-38%), respectively. At 6 months, the biochemically confirmed point-prevalence and prolonged smoking abstinence rates were 20% (95% CI=10%-34%) and 16% (95% CI=7%-29%), respectively. Among subjects who continued to smoke and completed the follow-up assessments, the reported number of cigarettes smoked per day (mean+/-standard deviation) was significantly less than at baseline: -10.0+/-8.2 (p<.001). Adverse effects were minor and well tolerated. Our results suggest that gabapentin may increase smoking abstinence. An adequately powered randomized clinical trial assessing different doses of this drug against a placebo would be the reasonable next step.     

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.     

Stay away from tobacco: a pilot trial of a school-based adolescent smoking prevention program in Beijing, China.

A quasiexperimental study was conducted to explore the efficacy of the program Stay Away from Tobacco (SAFT). Participants-from 11 classes with 381 students total in grades 7, 8, 10, and 11-were assigned by class to three groups (intervention group T with school teachers delivering the program, intervention group R with researchers delivering the program, and comparison group C). Data were collected at baseline, immediately after the intervention, and 6 months after the intervention. Self-reported smoking was the outcome measure. The 30-day smoking prevalence in group C increased from 4% at baseline to 10% at the 6-month follow-up, whereas this rate declined from 11% to 6% in group T, and from 9% to 1% in group R. For group T, the odds ratio (for 30-day smoking) and the regression coefficient (for indexed number of cigarettes smoked) assessing interactions between intervention and time were 0.20 (p < .001) and -.1605 (p < .05), respectively. The same statistics for group R were 0.09 (p < .001) and -.2406 (p < .01), respectively. The predicted smoking rate declined by 19% from baseline to 6-month follow-up in group T (11.5% vs. 9.3%), and the same rate declined by 26% in group R (11.1% vs. 8.2%). The results from this pilot trial suggest that SAFT can reduce cigarette smoking among middle and high school students through its effect on improving these students' refusal skills and changing their perceived mental and physical values from smoking. A full-scale evaluation is recommended.     

Is concern about post-cessation weight gain a barrier to smoking cessation among pregnant women?

Women who quit smoking during pregnancy gain more weight than women who continue to smoke. Concern about weight gain is a barrier to smoking cessation in the general population, but whether attitudes about weight are associated with failure to stop smoking during pregnancy or to maintain abstinence postpartum is unknown. Thus, attitudes about weight were assessed in 412 pregnant smokers recruited from obstetric practices in Massachusetts for a smoking cessation intervention trial. Smoking cessation outcomes (7-day point-prevalence abstinence by self-report and by cotinine-validation) were assessed at end-of-pregnancy and 3 months postpartum. Bivariate and multivariable analyses assessed the relationship between attitudes about weight and smoking cessation. In bivariate analyses, a high level of concern about post-cessation weight gain was associated with older age (p = .01), smoking more cigarettes/day (p<.001), not making a quit attempt in pregnancy (p = .02), being less likely to self-report tobacco abstinence at end of pregnancy (p = .01) and postpartum (p = .02), and having less cotinine-validated abstinence at 3 months postpartum (p = .05). In multivariable analyses that adjusted for cigarettes/day, a low level of concern about post-cessation weight gain was associated with more self-reported abstinence at end-of-pregnancy (OR = 1.77, 95% CI 1.01-3.09) and postpartum (OR = 2.09, 95% CI 1.05-4.14), but not with cotinine-validated abstinence at end-of-pregnancy (OR = 1.30, 95% CI 0.63-2.68) or postpartum (OR = 2.18, 95% CI 0.93-5.10). In conclusion, women who are more concerned about post-cessation weight gain may be less likely to quit smoking during pregnancy or remain abstinent in the postpartum period.     

The effectiveness of a nurse-managed perinatal smoking cessation program implemented in a rural county.

The present study (a) examined the effectiveness of a nurse-managed smoking cessation program, that was totally integrated into routine perinatal care, on the cessation rates of pregnant smokers in a rural community, and (b) assessed the subject characteristics associated with smoking cessation success. Data were collected from a convenience sample of 194 pregnant women who stated that they were smokers at the onset of their pregnancies. The study compared the effects of usual care (n = 93) versus the Smoke Free Baby & Me program (n = 101), which included the American Cancer Society's Make Yours a Fresh Start Family program. Smoking status was measured by self-report and urinary cotinine at four points during pregnancy and postpartum. At the postpartum visit, more women in the experimental group reported that they were not smoking compared with those in the control group (37.3% vs. 16.7%), Pearson's chi2 (n = 87) = 4.37, p = .037, and they had higher validated (urinary cotinine <200 ng/ml) smoking cessation rates (n = 80, t = 2.449, p = .017) if they had quit smoking by the first prenatal visit. Smoking cessation was positively associated with level of education and negatively associated with gravidity, parity, the number of smokers in the household, and the number of cigarettes smoked per day at the first prenatal visit. Significant discordance was found between self-report and urinary cotinine assays at all prevalence points, regardless of group. In conclusion, this nurse-delivered program integrated into perinatal care influenced the smoking behaviors of "recent quitters" but had no effect on those who reported smoking at the first prenatal visit. Implications for clinical practice are discussed.     

Evaluation of a culturally appropriate smoking cessation intervention for Latinos

BACKGROUND: Many believe that smoking cessation programmes for Latinos should be tailored to the values and beliefs of the culture. However, randomised studies of culturally appropriate smoking cessation interventions with Latinos are rare. METHODS: Latino smokers (n = 313) were randomised to an intervention condition or a comparison group. The intervention was a three month programme based on social cognitive constructs and delivered in the smoker's home by trained lay health advisors, or promotores. Comparison group participants were referred to the California Smoker's Helpline in Spanish. Predictors of abstinence among all participants also were examined. RESULTS: About one week post-intervention, validated (carbon monoxide) past week abstinence rates were more than twice as high in the intervention group (20.5%) than in the comparison (8.7%) (p < or = 0.005). The pattern of results held for self reported abstinence, and after recoding dropouts to non-abstinence. The primary predictor of abstinence was number of cigarettes smoked per day at baseline, a common measure of addiction. CONCLUSIONS: The culturally appropriate intervention facilitated abstinence in Latino smokers, at least in the short term. Strengths and weaknesses of the study are discussed.     

Smoking cessation with smokeless tobacco and group therapy: an open, randomized, controlled trial

Smokeless tobacco might be effective as an adjunct for smoking cessation. We evaluated the efficacy of smokeless tobacco and group support for smoking cessation in an open, randomized study that compared smokeless tobacco plus group support versus group support only. The study enrolled 263 healthy smokers (M (age) = 49 years) who smoked a mean of 24 cigarettes/day, with a mean of 31 pack-years. Smokeless tobacco was provided for 7 weeks (or up to 12), combined with eight group support visits provided by nurses. The control group received group support only. Smoking cessation rates were statistically significantly better in the smokeless tobacco group than in the control group during the first 7 weeks. Point-prevalence abstinence rates at 7 weeks were 36.4% versus 20.8% (OR = 2.52, p = .001), respectively; and continuous abstinence rates from weeks 4 to 7 were 31.5% versus 19.2% (OR = 1.94, p = .023), respectively. The primary outcomes (i.e., 6-month point prevalence) were 23.1% versus 20.8%, respectively (OR = 1.31, ns). Smokeless tobacco was relatively well tolerated, although 15 subjects (11.2%) stopped use due to adverse events. A total of 25 subjects (17.5 %) were still using smokeless tobacco after 6 months. This trial demonstrated short-term efficacy of smokeless tobacco in combination with group support for smoking cessation but no long-term efficacy.     

Predictors of smoking cessation among elderly smokers treated for nicotine dependence

OBJECTIVE: To examine outcomes and predictors of smoking cessation among elderly patients treated for nicotine dependence. DESIGN: Retrospective analysis of patients aged 65-82 who received a nicotine dependence consultation at the Mayo Medical Center between 1 April 1988 and 30 May 1992. Patients were contacted by telephone by a trained interviewer six months after the consultation and were sent a follow-up survey in August 1993. SETTING: Mayo Medical Center, Rochester, Minnesota, United States. SUBJECTS: A total of 613 patients (310 men, 303 women) with a mean age of 69.0 (SD 3.5) years were seen during the study period. MAIN OUTCOME MEASURES: Point prevalence self-reported smoking status. Patients were considered abstinent if they self- reported not smoking (not even a puff) during the seven days before contact. RESULTS: At six-month follow up, 24.8% of the 613 patients reported abstinence from smoking. On multivariate analysis, smoking abstinence was more likely if patients were hospitalised at the time of the consultation, married to a non-smoking spouse, very motivated to stop smoking, and reported their longest time of previous abstinence to be less than a day or more than a month. The response rate to the mailed follow-up survey was 69.9% (429 of 613). The mean duration of follow up was 40.0 +/- 13.2 months following the consultation. Of the 429 patients, 103 (24.0%) reported abstinence from smoking and 326 (76.0%) were smoking at six-month follow up. Patients who reported abstinence at six months had a higher cessation rate at the last follow up (76.0%) compared with patients who were smoking at six-month follow up (33.0%, P < 0.001). For patients who were not smoking at six months, no factors were found to significantly predict abstinence at last follow up. For patients who were smoking at six months, factors associated with smoking cessation at last follow up were: more than a year as the longest time off cigarettes before the consultation; counsellor rating of less severe nicotine dependence; and older age at first regular smoking. CONCLUSIONS: Several predictors of smoking cessation were identified in this study which may be useful for tailoring smoking interventions for the elderly.


     

Telephone booster sessions for optimizing smoking cessation for patients in rehabilitation centers.

Smokers with smoking-related diseases who are hospitalized in rehabilitation centers should be offered smoking cessation. This is the first study evaluating whether telephone booster sessions after intensive inpatient treatment are an effective strategy. The present study was conducted in 13 rehabilitation centers for somatic disorders as a prospective multicenter study with a randomized treatment-control group design. We compared abstinence rates after hospital discharge from treatment that included a group smoking cessation program with (treatment group) and without telephone booster sessions (control group). Data from 290 smokers were analyzed. After 6 and 12 months the treatment group achieved abstinence rates twice as high as those of the control group. Men profited more from telephone booster sessions than did women. Results indicated that telephone booster sessions were highly effective (even) after an inherently intensive group program during a hospital stay. Further research should focus on the special needs of women receiving telephone counseling.     

Tobacco craving predicts lapse to smoking among adolescent smokers in cessation treatment.

Previous research indicates that tobacco craving predicts relapse to smoking among adult smokers attempting to quit. We hypothesized a similar relationship between craving and lapse (any smoking following a period of abstinence) among adolescent smokers during the treatment phase of a clinical trial. A visit was considered a lapse visit if the participant reported smoking or had a carbon monoxide level of 7 ppm or greater subsequent to an abstinent visit. A total of 34 participants (mean age = 14.9 years [SD = 1.3]; mean cigarettes/day = 18.0 [SD = 7.6]; mean Fagerstr?m Test for Nicotine Dependence score = 6.8 [SD = 1.34]; 65% female), were included in the present analysis of 167 treatment visits. Logistic regression analyses showed a positive relationship between degree of craving, measured by the Questionnaire on Smoking Urges, and lapse during smoking cessation treatment (p = .013). Additionally, linear regression analyses demonstrated a strong positive association between cigarettes smoked per day and craving scores (p<.001). Taken together with other data, these findings suggest that degree of craving might influence tobacco abstinence for adolescent smokers. Thus monitoring and addressing craving appears useful to increase the success of adolescent smoking cessation.     

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.     

Sex-related differences in serum cotinine concentrations in daily cigarette smokers

Self-reported use of cigarettes generally underestimates the true cigarette exposure of smokers. Serum cotinine is considered the best biomarker to evaluate tobacco exposure. This study determined whether or not there were any significant differences in serum cotinine concentrations between men and women when they reported smoking the same number of cigarettes per day. We analyzed cotinine and tobacco consumption data on 680 women and 840 men, aged 20 years or older, who smoked at least 100 cigarettes during their lifetime and were still actively smoking at the time of the National Health and Nutrition Examination Surveys (1999-2002). Overall, compared with men, women reported smoking fewer cigarettes per day (16.1 vs. 18.7, p<.001) and had lower serum cotinine concentrations (1163.3 nmol/L vs. 1343.9 nmol/L, p<.001). Women were more likely than men to smoke filtered (p = .018) and mentholated (p<.001) cigarettes. After adjustment for the number of cigarettes smoked per day, age, race, body mass index, poverty status, the use of either menthol or regular cigarettes, and the nicotine content in cigarettes, female compared with male smokers had lower serum cotinine concentrations (difference of 117.6 nmol/L; 95% CI = 42.6-192.6, p = .003). The difference was particularly notable in moderate to heavy smokers (i.e., those who smoked more than 15 cigarettes/day). These findings indicate that significant sex-related differences exist in serum cotinine levels among smokers, which suggests that self-reports may overestimate cigarette exposure in women compared with men.     

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.     

Commit to Quit in the YMCAs: translating an evidence-based quit smoking program for women into a community setting.

Approximately 22% of women continue to smoke cigarettes despite the increased risk of cancer associated with smoking. Regular aerobic exercise added to our Commit to Quit smoking cessation program for women improved cessation rates compared with the same cessation program plus equal contact time. This trial tested the feasibility of conducting Commit to Quit in the YMCA setting. Among the 77 women who attended informational sessions, 68% (n = 52) were eligible and 56% (N = 43) enrolled in one of five cohorts. All cohorts received the same intervention: the Commit to Quit smoking cessation program, led by Ph.D.-level psychologists, coupled with the YMCA Personal Fitness Program, led by YMCA personal trainers. On quit day in the program 17 women (39.5%) reported a 24-hr quit, and by the end of treatment 3 women (7.0%) reported a 7-day quit. Intent-to-treat analysis (baseline values carried forward) revealed a decrease in the mean number of cigarettes smoked from 9.9 at baseline (SD = 5.0) to 4.8 at the end of treatment (SD = 5.2; t = 4.7; p<.001). Self-reported exercise increased from 530.3 kcal (SD = 587.0) at baseline to 1,256.4 kcal (SD = 1,263.1) at end of treatment (t = -2.489 p = .017). Participants reported high ratings of satisfaction with the smoking cessation program and Personal Fitness Program. Preliminary feasibility and acceptability were demonstrated as we translated an evidence-based intervention into the YMCA setting.