Cost-effectiveness of self-help smokeless tobacco cessation programs.

This study assessed the cost-effectiveness of two low-intensity programs for quitting smokeless tobacco, based on results of a randomized trial with 1,069 volunteer participants. Cost data were collected for two levels of intervention: manual only (a self-help manual) and assisted self-help (the manual plus a videotape and two supportive phone calls from tobacco cessation counselors). Incremental cost-effectiveness ratios were calculated for assisted self-help vs. quitting on one's own, using the manual-only quit rate and data from another study as alternative proxies for no intervention. A threshold analysis was conducted to determine the spontaneous quit rate at which the manual-only intervention becomes more cost-effective than assisted self-help. The cost to provide and receive the assisted self-help intervention averaged US $56 per participant vs. $20 for the manual-only intervention (societal perspective, Year 2000 dollars). Estimates for incremental cost per quit for the assisted self-help intervention ranged from $922 to $1,758, depending on the proxy used for no intervention. The manual-only intervention was more cost-effective than assisted self-help if quitting among motivated chewers who do not receive treatment does not exceed 3.4%. Support from a wife or partner added little cost to a quit attempt for male chewers ($3-$4). Providing a manual, video, and brief phone counseling to smokeless tobacco users who want to quit is a reasonable use of health care resources. The self-help quitting guide also may be a cost-effective treatment, but it remains to be demonstrated whether it is more effective than quitting on one's own.     

Changes in psychiatric patients' thoughts about quitting smoking during a smoke-free hospitalization.

Though exempted from national bans of tobacco smoking in hospitals, some psychiatric facilities have voluntarily gone 100% smoke free with little reported difficulty in clinical management. The impact of smoking restrictions on psychiatric patients' thoughts about quitting smoking, however, is not known. This study investigates changes in thoughts about quitting smoking for patients hospitalized in a smoke-free psychiatric inpatient facility. Participants were 100 smokers recruited from a university-based adult inpatient psychiatry unit. The present study focused on participants' reported desire to quit smoking, their expectancy of success and anticipated difficulty with quitting, and their smoking abstinence goal. Assessments were conducted at hospital intake and shortly before hospital discharge. Follow-up assessments were conducted by phone at 1 week, 1 month, and 3 months post-hospitalization to measure smoking behavior. Although no cessation treatment was provided in this observational study, from admission to discharge, participants reported an increased expectancy of success with quitting and a decreased expectancy of difficulty with staying quit. They also were more likely to endorse a smoking-related goal. Psychiatric diagnosis was not related to thoughts about abstinence. Furthermore, participants' thoughts about abstinence at discharge were significantly related to their subsequent smoking behavior. Hospitalization in a smoke-free environment is associated with increases in patients' expectancies about quitting and staying smoke free.     

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.     

Evaluating the effectiveness of a single telephone contact as an adjunct to a self-help intervention for smoking cessation in a randomized controlled trial.

This study evaluated the effects of including a single brief prequit telephone counseling session in a self-help program for smoking cessation conducted through the mail, by comparison with the effects of the self-help program alone. Volunteer participants from northwestern Spain (N = 228) were randomly assigned to one of two groups: (a) the self-help-only group (n = 110, mean age = 37.4 years, pretreatment cigarette consumption = 26.5 cigarettes/day) or (b) the telephone-support group (n = 118, mean age = 36.8 years, pretreatment cigarette consumption = 27.7 cigarettes/day). Using a conservative data analysis method (missing data considered as treatment failures), we found that the point-prevalence abstinence rate was significantly higher in the telephone-support group than in the self-help-only group at the end of treatment (44.9% vs. 21.8%) and at the 3-month follow-up (39.0% vs. 26.4%). Likewise, sustained abstinence was significantly higher in the telephone-support group at the 3-month follow-up (33.9% vs. 13.6%), the 6-month follow-up (25.4% vs. 12.7%), and the 12-month follow-up (21.2% vs. 9.1%). The results of this randomized controlled trial indicate that both treatments are an effective aid for smoking cessation, and that a single brief telephone call before the quit date is a low-cost and effective procedure for improving abstinence rates in a mailed self-help program.     

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.     

Clinical trials and tribulations: lessons learned from recruiting pregnant ex-smokers for relapse prevention.

The development of smoking cessation and relapse prevention interventions for pregnant and postpartum women is a public health priority. However, researchers have consistently reported substantial difficulty in recruiting this population into clinical trials. The problem is particularly acute for relapse prevention studies, which must recruit women who have already quit smoking because of their pregnancy. Although these individuals are an important target for tobacco control efforts, they represent an extremely small subgroup of the general population. This paper describes multiple recruitment strategies used for a clinical trial of a self-help relapse prevention program for pregnant women. The effectiveness of the strategies and the direct expense per participant recruited are provided. A proactive recruitment strategy (telephoning women whose phone numbers were purchased from a marketing firm) was ultimately much more successful than a variety of reactive strategies (advertisements, press releases, direct mail, Web placement, health care provider outreach). We found few differences between proactively and reactively recruited participants on baseline variables. The primary difference was that the former had smoked fewer cigarettes per day and reported lower nicotine dependence prior to quitting. Strengths and limitations of the recruitment strategies are discussed.     

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.     

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.     

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.     

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.     

Self-help interventions for older smokers

OBJECTIVE: To evaluate the relative effectiveness of two self-help smoking interventions as adjuncts to a self-help manual and telephone support service (hotline) for older smokers. DESIGN: Subjects were stratified on baseline variables and randomised to one of two treatment conditions in a methods development study. SUBJECTS: 177 community- dwelling smokers aged 60 years and older. INTERVENTIONS: All subjects received a self-help manual and access to a smokers' telephone hotline. Subjects also received either mailings (Letters condition) or counselling telephone calls (Proactive condition) at four and eight weeks after enrollment. MAIN OUTCOME MEASURES: Use of the hotline and prevalence of abstinence lasting at least 48 hours (verified by a "significant other") were assessed at three and six months for the full sample. Seven-day abstinence was calculated for comparison with previous research. A subsample of 91 subjects was followed up at 12 months. RESULTS: Overall abstinence rates for the two conditions were in the range of typical self-help interventions. Men were more likely to be abstinent than women at follow up at three and six months. A significant gender x treatment interaction was found, with abstinence rates higher for men in the Letters condition, and women in the Proactive condition. Hotline use was high, with nearly half of subjects calling by 12 months. CONCLUSION: Both interventions appear promising for older smokers, but may be differentially effective for men and women. Older smokers will use a hotline; whether Letters and Proactive interventions can improve on manual and hotline effectiveness rates alone is being tested in a subsequent controlled trial.


     

An experimental test of the influence of prior cigarette smoking abstinence on future abstinence.

Significant positive associations between early and later abstinence are often reported in clinical trials on smoking cessation, but those relationships do not permit causal inferences. The present study was conducted to examine experimentally whether prior smoking abstinence histories can directly facilitate later abstinence, using a contingency management procedure to manipulate prior abstinence. A total of 40 adult cigarette smokers who were not trying to quit were randomly assigned to one of two conditions: Contingent ALL (C-ALL), who earned monetary incentives contingent on smoking abstinence during three 5 day experimental periods; or Contingent LAST (C-LAST), who earned incentives independent of abstinence during the first two periods (i.e., noncontingent payments) and contingent on abstinence during the final period. The contingency management procedure was effective in establishing different abstinence histories in the two conditions during the first two periods. Comparison of abstinence levels between the C-ALL and C-LAST conditions during the third period showed significantly greater abstinence in the C-ALL condition, although nicotine withdrawal and other subject ratings generally did not differ significantly between the two conditions. These results provide experimental evidence that prior abstinence histories can directly influence subsequent efforts to abstain from smoking.     

Tobacco control policies and the concurrent use of smokeless tobacco and cigarettes among men, 1992-2002.

Accelerating the decline in smoking prevalence requires an understanding of changes in the concurrent use of and the substitution between different tobacco products, such as smokeless tobacco (SLT) and cigarettes. SLT could play an important role in reducing the toll of smoking-related illness and premature mortality. Research examining the role of tobacco control policies in explaining concurrent use of SLT and cigarettes has been minimal. Using the Current Population Survey Tobacco Use Supplements (CPS-TUS), we examined tobacco control policies in relationship with adult males' SLT use concurrent with smoking over the period 1992-2002. Consistent with the decline in smokeless-only and cigarette-only rates, concurrent use of SLT and cigarettes declined during the period. SLT users, faced with home or workplace smoking bans, are less likely to report smoking. Smokers with a home ban appear more likely to use SLT, but in more recent years, smokers with a workplace ban are less likely to use SLT. Tobacco excise taxes do not signal substitution between cigarettes and SLT products. Understanding current use patterns of the range of tobacco products, including their interaction with available policy levers, is vital in assessing whether changes that might promote substitution of arguably less toxic SLT products for highly toxic cigarettes are likely to lead to net public health gains or losses. Findings of the present study, in concert with other research about transitional probabilities between behavioral states, will inform the design of an effective policy framework that supports the objective of reducing tobacco-related death and disease.     

Smoking reduction fails to improve clinical and biological markers of cardiac disease: a randomized controlled trial.

Cigarette reduction has been proposed as a treatment goal for smokers who are not interested in stopping completely. This randomized controlled trial was designed to determine the effect of a smoking reduction intervention on smoking behavior, symptoms of heart disease, and biomarkers of tobacco exposure. It included 152 patients with heart disease who did not intend to stop smoking in the next 30 days. Participants were randomly assigned to smoking reduction (SR) or usual care (UC). SR subjects received counseling and nicotine replacement therapy to encourage > or =50% reduction in cigarettes per day (CPD). They were followed at 1, 3, 6, 12 and 18 months to assess smoking, heart disease symptoms, quality of life and nicotine, cotinine, carbon monoxide (CO), white blood cell (WBC) count, fibrinogen, hs-C-reactive protein (hs-CRP), F2-isoprostane, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL), and 1-hydroxypyrene (1-HOP). At 6 months SR participants reduced by 10.9 CPD, compared with 7.4 CPD in UC (difference NS). At 18 months, 9/78 SR vs. 9/74 UC participants quit smoking. There were no significant differences between treatment groups in angina, quality of life or adverse events, nicotine, cotinine, CO, WBC count, fibrinogen, hs-CRP, F2-isoprostane, total NNAL or 1-HOP levels at any time point. To determine if smoking reduction, regardless of treatment condition, was associated with improved outcomes, we compared all subjects at 6 months to baseline (mean reduction in CPD from 27.4 to 18.1, p<.01). There were no significant changes in outcome variables except CO, which decreased by 5.5 ppm (p<.01). There were also no significant improvements considering only subjects who reduced by > or =50%, or those who had no history of reduction prior to enrollment in the study. The SR intervention did not significantly reduce CPD or toxin exposure, or improve smoking cessation or clinical outcomes compared to UC. These results emphasize the importance of abstinence for smokers with heart disease to minimize health risks from tobacco.     

Brief report: pain and readiness to quit smoking cigarettes.

This study explored the relationship between smoking and significant pain. It was hypothesized that readiness to quit smoking would be negatively affected by pain issues. A cross-sectional design was used in this phone-based survey with randomly selected adult smokers. A total of 307 adult participants in the control group from a larger Quit and Win Study participated in the interview. Participants were contacted at home and completed a 20-min phone survey including measures of pain, stress, depressive symptoms, social support, tobacco use status, and readiness to quit smoking. A total of 28% reported significant pain in the past week. Participants who experienced significant pain smoked more cigarettes per day than those who did not report significant pain. However, pain was not associated with readiness to quit. More than half (58%) of those with significant pain were in the contemplation stage of change or higher. The fact that smokers with pain were just as likely as those without significant pain to be ready to quit demands that each individual patient with pain be assessed for readiness to quit so that a tailored approach can be adopted either to motivate the patient to quit or to assist the patient with evidence-based tobacco dependence treatment strategies if he or she wants such treatment. Placing formal tobacco dependence treatment programs within pain clinics and addressing pain in smoking cessation programs 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.     

Nicotine delivery capabilities of smokeless tobacco products and implications for control of tobacco dependence in South Africa

Objectives: Smokeless tobacco (SLT) use is popular among black South African women and children. The study sought to determine the nicotine delivery capability of popular industrialised and traditional SLT brands in South Africa, and to provide information for policy action by regulatory authorities.

Design: Laboratory chemical analysis of four industrialised and one traditional SLT products commercially available, using previously published analytical methods. Potential for dependence was inferred from nicotine delivery capabilities determined by the percentage free base nicotine.

Measurements: Moisture, pH, total nicotine, and percentage free base nicotine.

Results: Total nicotine content was between 6–16 mg/g. The pH varied between 7–10 and this correlated with percentage free base nicotine, which ranged between 10–99%. The nicotine delivery capability of the traditional product was lower than that of the industrialised products except for the recently introduced portion bag snus, which had comparable total nicotine but the lowest pH and percentage free base nicotine. The most popular SLT brands showed the highest percentage free base nicotine ever reported for any industrialised SLT or cigarette brands. Small cans contained higher nicotine than the large cans of the same brand tested. Findings from the study support a potential for limited "product graduation" by users.

Conclusions: South African SLT users are mostly exposed to potentially very highly addictive levels of nicotine that may favour tobacco dependence and its consequent health risks. The increasing use of SLT by women of childbearing age support the need for intensified policy action to control its use.