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Background: Many smokers give up smoking on their own, but materials that provide a structured programme for smokers to follow may increase the number who quit successfully., Objectives: The aims of this review were to determine the effectiveness of different forms of print-based self-help materials that provide a structured programme for smokers to follow, compared with no treatment and with other minimal contact strategies, and to determine the comparative effectiveness of different components and characteristics of print-based self-help, such as computer-generated feedback, additional materials, tailoring of materials to individuals, and targeting of materials at specific groups., Search Methods: We searched the Cochrane Tobacco Addiction Group Trials Register, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP). The date of the most recent search was March 2018., Selection Criteria: We included randomised trials of smoking cessation with follow-up of at least six months, where at least one arm tested print-based materials providing self-help compared with minimal print-based self-help (such as a short leaflet) or a lower-intensity control. We defined 'self-help' as structured programming for smokers trying to quit without intensive contact with a therapist., Data Collection and Analysis: We extracted data in accordance with standard methodological procedures set out by Cochrane. The main outcome measure was abstinence from smoking after at least six months' follow-up in people smoking at baseline. We used the most rigorous definition of abstinence in each study and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a random-effects model., Main Results: We identified 75 studies that met our inclusion criteria. Many study reports did not include sufficient detail to allow judgement of risk of bias for some domains. We judged 30 studies (40%) to be at high risk of bias for one or more domains.Thirty-five studies evaluated the effects of standard, non-tailored self-help materials. Eleven studies compared self-help materials alone with no intervention and found a small effect in favour of the intervention (n = 13,241; risk ratio (RR) 1.19, 95% confidence interval (CI) 1.03 to 1.37; I² = 0%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for indirect relevance to populations in low- and middle-income countries because evidence for this comparison came from studies conducted solely in high-income countries and there is reason to believe the intervention might work differently in low- and middle-income countries. This analysis excluded two studies by the same author team with strongly positive outcomes that were clear outliers and introduced significant heterogeneity. Six further studies of structured self-help compared with brief leaflets did not show evidence of an effect of self-help materials on smoking cessation (n = 7023; RR 0.87, 95% CI 0.71 to 1.07; I² = 21%). We found evidence of benefit from standard self-help materials when there was brief contact that did not include smoking cessation advice (4 studies; n = 2822; RR 1.39, 95% CI 1.03 to 1.88; I² = 0%), but not when self-help was provided as an adjunct to face-to-face smoking cessation advice for all participants (11 studies; n = 5365; RR 0.99, 95% CI 0.76 to 1.28; I² = 32%).Thirty-two studies tested materials tailored for the characteristics of individual smokers, with controls receiving no materials, or stage-matched or non-tailored materials. Most of these studies used more than one mailing. Pooling studies that compared tailored self-help with no self-help, either on its own or compared with advice, or as an adjunct to advice, showed a benefit of providing tailored self-help interventions (12 studies; n = 19,190; RR 1.34, 95% CI 1.20 to 1.49; I² = 0%) with little evidence of difference between subgroups (10 studies compared tailored with no materials, n = 14,359; RR 1.34, 95% CI 1.19 to 1.51; I² = 0%; two studies compared tailored materials with brief advice, n = 2992; RR 1.13, 95% CI 0.86 to 1.49; I² = 0%; and two studies evaluated tailored materials as an adjunct to brief advice, n = 1839; RR 1.72, 95% CI 1.17 to 2.53; I² = 10%). When studies compared tailored self-help with non-tailored self-help, results favoured tailored interventions when the tailored interventions involved more mailings than the non-tailored interventions (9 studies; n = 14,166; RR 1.42, 95% CI 1.20 to 1.68; I² = 0%), but not when the two conditions were contact-matched (10 studies; n = 11,024; RR 1.07, 95% CI 0.89 to 1.30; I² = 50%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for risk of bias.Five studies evaluated self-help materials as an adjunct to nicotine replacement therapy; pooling three of these provided no evidence of additional benefit (n = 1769; RR 1.05, 95% CI 0.86 to 1.30; I² = 0%). Four studies evaluating additional written materials favoured the intervention, but the lower confidence interval crossed the line of no effect (RR 1.20, 95% CI 0.91 to 1.58; I² = 73%). A small number of other studies did not detect benefit from using targeted materials, or find differences between different self-help programmes., Authors' Conclusions: Moderate-certainty evidence shows that when no other support is available, written self-help materials help more people to stop smoking than no intervention. When people receive advice from a health professional or are using nicotine replacement therapy, there is no evidence that self-help materials add to their effect. However, small benefits cannot be excluded. Moderate-certainty evidence shows that self-help materials that use data from participants to tailor the nature of the advice or support given are more effective than no intervention. However, when tailored self-help materials, which typically involve repeated assessment and mailing, were compared with untailored materials delivered similarly, there was no evidence of benefit.Available evidence tested self-help interventions in high-income countries, where more intensive support is often available. Further research is needed to investigate effects of these interventions in low- and middle-income countries, where more intensive support may not be available.

Background: Many smokers give up smoking on their own, but materials giving advice and information may help them and increase the number who quit successfully., Objectives: The aims of this review were to determine: the effectiveness of different forms of print-based self-help materials, compared with no treatment and with other minimal contact strategies; the effectiveness of adjuncts to print-based self help, such as computer-generated feedback, telephone hotlines and pharmacotherapy; and the effectiveness of approaches tailored to the individual compared with non-tailored materials., Search Methods: We searched the Cochrane Tobacco Addiction Group trials register. Date of the most recent search April 2014., Selection Criteria: We included randomized trials of smoking cessation with follow-up of at least six months, where at least one arm tested a print-based self-help intervention. We defined self help as structured programming for smokers trying to quit without intensive contact with a therapist., Data Collection and Analysis: We extracted data in duplicate on the participants, the nature of the self-help materials, the amount of face-to-face contact given to intervention and to control conditions, outcome measures, method of randomization, and completeness of follow-up.The main outcome measure was abstinence from smoking after at least six months follow-up in people smoking at baseline. We used the most rigorous definition of abstinence in each trial, and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a fixed-effect model., Main Results: We identified 74 trials which met the inclusion criteria. Many study reports did not include sufficient detail to judge risk of bias for some domains. Twenty-eight studies (38%) were judged at high risk of bias for one or more domains but the overall risk of bias across all included studies was judged to be moderate, and unlikely to alter the conclusions.Thirty-four trials evaluated the effect of standard, non-tailored self-help materials. Pooling 11 of these trials in which there was no face-to-face contact and provision of structured self-help materials was compared to no intervention gave an estimate of benefit that just reached statistical significance (n = 13,241, risk ratio [RR] 1.19, 95% confidence interval [CI] 1.04 to 1.37). This analysis excluded two trials with strongly positive outcomes that introduced significant heterogeneity. Six further trials without face-to-face contact in which the control group received alternative written materials did not show evidence for an effect of the smoking self-help materials (n = 7023, RR 0.88, 95% CI 0.74 to 1.04). When these two subgroups were pooled, there was no longer evidence for a benefit of standard structured materials (n = 20,264, RR 1.06, 95% CI 0.95 to 1.18). We failed to find evidence of benefit from providing standard self-help materials when there was brief contact with all participants (5 trials, n = 3866, RR 1.17, 95% CI 0.96 to 1.42), or face-to-face advice for all participants (11 trials, n = 5365, RR 0.97, 95% CI 0.80 to 1.18).Thirty-one trials offered materials tailored for the characteristics of individual smokers, with controls receiving either no materials, or stage matched or non-tailored materials. Most of the trials used more than one mailing. Pooling these showed a benefit of tailored materials (n = 40,890, RR 1.28, 95% CI 1.18 to 1.37) with moderate heterogeneity (I² = 32%). The evidence is strongest for the subgroup of nine trials in which tailored materials were compared to no intervention (n = 13,437, RR 1.35, 95% CI 1.19 to 1.53), but also supports tailored materials as more helpful than standard materials. Part of this effect could be due to the additional contact or assessment required to obtain individual data, since the subgroup of 10 trials where the number of contacts was matched did not detect an effect (n = 11,024, RR 1.06, 95% CI 0.94 to 1.20). In two trials including a direct comparison between tailored materials and brief advice from a health care provider, there was no evidence of a difference, but confidence intervals were wide (n = 2992, RR 1.13, 95% CI 0.86 to 1.49).Only four studies evaluated self-help materials as an adjunct to nicotine replacement therapy, with no evidence of additional benefit (n = 2291, RR 1.05, 95% CI 0.88 to 1.25). A small number of other trials failed to detect benefits from using additional materials or targeted materials, or to find differences between different self-help programmes., Authors' Conclusions: Standard, print-based self-help materials increase quit rates compared to no intervention, but the effect is likely to be small. We did not find evidence that they have an additional benefit when used alongside other interventions such as advice from a healthcare professional, or nicotine replacement therapy. There is evidence that materials that are tailored for individual smokers are more effective than non-tailored materials, although the absolute size of effect is still small. Available evidence tested self-help interventions in high income countries; further research is needed to investigate their effect in contexts where more intensive support is not available.

Background: In patients with schizophrenia, the smoking cessation rate is low and the burden of smoking-related morbidity and mortality is high. Identification of factors associated with abstinence may allow clinicians to optimize treatment prior to a smoking cessation attempt., Method: To identify factors associated with successful smoking cessation in patients with a DSM-IV diagnosis of schizophrenia, we analyzed baseline data from 114 stable outpatient smokers with schizophrenia who participated in 1 of 2 smoking cessation trials. The outcome of interest was 4 weeks' continuous abstinence at the end of a 12-week nicotine dependence treatment intervention. Baseline factors associated with abstinence were identified with univariate methods and entered into a manual, forward-selection multivariable regression model to identify independent predictors of abstinence. The study was conducted from March 1999 to February 2004., Results: Fourteen of 114 participants (12%) had biochemically verified 4 weeks' continuous abstinence at week 12. We included 10 noncorrelated variables with a univariate association with abstinence in a multivariable model, controlling for pharmacotherapy, age, and gender. Age at initiation of smoking and baseline variability in attentiveness, as measured by Continuous Performance Test-AX (CPT-AX) hit reaction time standard error, were independently associated with abstinence. For every year increase in age at initiation of smoking, the OR for abstinence was 1.36 (95% CI = 1.01 to 1.83), p = .048. For every millisecond decrease in the variability of the reaction time of CPT-AX, the OR for achieving abstinence was 1.55 (95% CI = 1.07 to 2.24), p = .021., Conclusion: Later initiation of smoking was associated with increased and baseline attentional impairment with reduced odds of abstinence. Additional research to further our understanding of the relationship between attentional impairment and cigarette smoking in schizophrenia may lead to improved nicotine dependence treatments for this group., (Copyright 2008 Physicians Postgraduate Press, Inc.)

Aims: Most relapse episodes occur when smokers are confronted with craving provoked by situational cues. Current nicotine gum can help relieve cue-provoked cravings, but faster effects may result in more rapid relief. We tested a prototype formulation of a new rapid-release nicotine gum (RRNG) that provides more rapid release and absorption of nicotine, for its ability to provide faster and better craving relief compared to current nicotine polacrilex gum (NPG)., Design: Random assignment to RRNG or NPG, used during a smoking cue provocation procedure. Participants and setting A total of 319 smokers were exposed to a smoking cue in the laboratory by being asked to light but not smoke a cigarette of their preferred brand. Subjects then chewed a piece of 2 mg RRNG (n = 159) or 2 mg NPG (n = 160) according to randomized assignment., Measurements: Craving assessments were completed at regular intervals before and after cue exposure (baseline, pre-cue, and 3, 6, 9, 12, 15, 18, 21, 25, 30 and 35 minutes after the cue)., Findings: Smokers chewing RRNG showed significantly lower craving than NPG subjects starting with the first assessment at 3 minutes (P < 0.025). Repeated-measures ANOVA revealed a significant treatment x time interaction (P < 0.05)-craving scores dropped more rapidly in RRNG subjects compared to NPG subjects. Survival analyses also indicated superiority of RRNG in achieving more rapid self-reported meaningful relief (P < 0.05) and complete relief (P < 0.05) of craving., Conclusions: Rapid-release nicotine gum reduced cue-provoked craving more rapidly compared to NPG, and thus merits further study in cessation efficacy trials.

Background: Nicotine polacrilex lozenges deliver 25% to 27% more nicotine compared with equivalent doses of nicotine polacrilex gum. The increased nicotine exposure from the lozenge has raised questions about the relative safety of the lozenge and gum., Objective: The objective of this study was to compare the safety profiles of the 4-mg nicotine lozenge and 4-mg nicotine gum in smokers with selected label-restricted diseases., Methods: This was a multicenter, randomized, open-label study in adult smokers with heart disease, hypertension not controlled by medication, and/or diabetes mellitus. Patients were randomized in a 1:1 ratio to receive the 4-mg nicotine lozenge or 4-mg nicotine gum. Safety assessments were made at baseline and at 2, 4, 6, and 12 weeks after the start of product use., Results: Nine hundred one patients were randomized to treatment, 447 who received the lozenge and 454 who received the gum (safety population). The majority were women (52.7%). Patients' mean age was 53.9 years, their mean weight was 193.9 pounds, and they smoked a mean of 25.2 cigarettes per day at baseline. Five hundred fifty-three patients, 264 taking the lozenge and 289 taking the gum, used the study product for > or =4 days per week during the first 2 weeks (evaluable population). The nicotine lozenge and nicotine gum were equally well tolerated, despite increased nicotine exposure from the lozenge. The incidence of adverse events in the 2 groups was similar during the first 2 weeks of product use (evaluation population: 55.3% lozenge, 54.7% gum), as well as during the entire study (safety population: 63.8% and 58.6%, respectively). Stratification of patients by sex, age, extent of concurrent smoking, extent of product use, and severity of adverse events revealed no clinically significant differences between the lozenge and gum. The most common adverse events were nausea (17.2% and 16.1%; 95% CI, -3.7 to 6.0), hiccups (10.7% and 6.6%; 95% CI, 0.5 to 7.8), and headache (8.7% and 9.9%; 95% Cl, -5.0 to 2.6). Serious adverse events were reported in 11 and 13 patients in the respective groups. Fewer than 6% of patients in either group were considered by the investigator to have a worsening of their overall disease condition during the study. The majority of patients (>60%) experienced no change in their disease status from baseline., Conclusion: The 4-mg nicotine lozenge and 4-mg nicotine gum had comparable safety profiles in these patients with label-restricted medical conditions.

Background: Many smokers give up smoking on their own, but materials giving advice and information may help them and increase the number who quit successfully., Objectives: The aims of this review were to determine the effectiveness of different forms of self-help materials, compared with no treatment and with other minimal contact strategies; the effectiveness of adjuncts to self help, such as computer-generated feedback, telephone hotlines and pharmacotherapy; and the effectiveness of approaches tailored to the individual compared with non-tailored materials., Search Strategy: We searched the Cochrane Tobacco Addiction Group trials register using the terms 'self-help', 'manual*' or 'booklet*'. Date of the most recent search April 2005., Selection Criteria: We included randomized trials of smoking cessation with follow up of at least six months, where at least one arm tested a self-help intervention. We defined self help as structured programming for smokers trying to quit without intensive contact with a therapist., Data Collection and Analysis: We extracted data in duplicate on the participants, the nature of the self-help materials, the amount of face-to-face contact given to intervention and to control conditions, outcome measures, method of randomization, and completeness of follow up. The main outcome measure was abstinence from smoking after at least six months follow up in people smoking at baseline. We used the most rigorous definition of abstinence in each trial, and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a fixed-effect model., Main Results: We identified sixty trials. Thirty-three compared self-help materials to no intervention or tested materials used in addition to advice. In 11 trials in which self help was compared to no intervention there was a pooled effect that just reached statistical significance (N = 13,733; odds ratio [OR] 1.24, 95% confidence interval [CI] 1.07 to 1.45). This analysis excluded two trials with strongly positive outcomes that introduced significant heterogeneity. Four further trials in which the control group received alternative written materials did not show evidence for an effect of the smoking self-help materials. We failed to find evidence of benefit from adding self-help materials to face-to-face advice, or to nicotine replacement therapy. There were seventeen trials using materials tailored for the characteristics of individual smokers, where meta-analysis supported a small benefit of tailored materials (N = 20,414; OR 1.42, 95% CI 1.26 to 1.61). The evidence is strongest for tailored materials compared to no intervention, but also supports tailored materials as more helpful than standard materials. Part of this effect could be due to the additional contact or assessment required to obtain individual data. A small number of other trials failed to detect benefits from using additional materials or targeted materials, or to find differences between different self-help programmes., Authors' Conclusions: Standard self-help materials may increase quit rates compared to no intervention, but the effect is likely to be small. We failed to find evidence that they have an additional benefit when used alongside other interventions such as advice from a healthcare professional, or nicotine replacement therapy. There is evidence that materials that are tailored for individual smokers are effective, and are more effective than untailored materials, although the absolute size of effect is still small.

Reviews of nicotine gum trials generally confirm the efficacy of this substitute in smoking cessation. However, little research has considered the efficacy of nicotine gum as a method for alleviating acute cravings in situations where smokers are not permitted to smoke. The aim of the present study was to evaluate the efficacy of nicotine gum in alleviating acute cravings for cigarettes using the subjective multi-dimensional Questionnaire of Smoking Urges (QSU) and the objective progressive ratio (PR) measures of craving. Forty-five regular smokers participated in a double-blind placebo-controlled trial. All participants were required to abstain from cigarettes for a period of 4 h. Fifteen of the participants were required to chew nicotine gum, 15 were required to chew placebo gum and 15 received no intervention during this abstinence period. All participants then completed the QSU, PR and mood and anxiety questionnaires. The results revealed that participants who had been in either of the gum conditions reported significantly lower QSU factor 1 and factor 2 craving scores after 4 h abstinence than those who had received no intervention. Although a significant partial correlation between QSU factor 1 and 2 scores and the number of reinforcers earned under the PR procedure was observed, the results revealed no significant difference between groups on measures of PR performance or mood and anxiety. Both nicotine and placebo gum are equally effective at reducing acute cravings for cigarettes.

Background: Since nicotine gum was introduced in the 1980s, nicotine replacement therapy has become the most widely used pharmacological smoking cessation treatment. Some smokers prefer acute oral forms, but many smokers reject chewing gum. We tested the safety and efficacy of a new nicotine polacrilex lozenge for smoking cessation., Methods: Double-blind, placebo-controlled, randomized clinical trial with parallel arms testing 2- and 4-mg nicotine lozenges. Smokers (n = 1818) were assigned to a lozenge dose on the basis of nicotine dependence, assessed by time to the first cigarette of the day. Low-dependence smokers were randomized to receive the 2-mg nicotine (n = 459) or placebo (n = 458) lozenge; high-dependence smokers, the 4-mg nicotine (n = 450) or placebo (n = 451) lozenge. We assessed abstinence at 6, 12, 24, and 52 weeks and analyzed craving and withdrawal symptoms., Results: Treatment with the nicotine lozenge resulted in significantly greater 28-day abstinence at 6 weeks, for the 2-mg (46.0% vs. 29.7%; odds ratio [OR], 2.10; 95% confidence interval [CI], 1.59-2.79; P<.001) and the 4-mg (48.7% vs. 20.8%; OR, 3.69; 95% CI, 2.74-4.96; P<.001) lozenges, compared with placebo. Significant treatment effects were maintained for a full year. Smokers who used more lozenges achieved significantly better treatment effects. Use of the active lozenge also resulted in reduced craving and withdrawal. Most adverse events were moderate and resembled those seen with nicotine gum., Conclusion: The nicotine lozenge is a safe and effective new treatment for smoking cessation in low- and high-dependence smokers.

Background: Many smokers give up smoking on their own, but materials giving advice and information may help them and increase the number who quit successfully., Objectives: The aims of this review were to determine the effectiveness of different forms of self-help materials, compared with no treatment and with other minimal contact strategies; the effectiveness of adjuncts to self-help, such as computer generated feedback, telephone hotlines and pharmacotherapy; and the effectiveness of approaches tailored to the individual compared with non-tailored materials., Search Strategy: We searched the Cochrane Tobacco Addiction Group trials register using the terms 'self-help', 'manual*' or 'booklet*'. Date of the most recent search March 2002., Selection Criteria: We included randomised trials of smoking cessation with follow-up of at least six months, where at least one arm tested a self-help intervention. We defined self-help as structured programming for smokers trying to quit without intensive contact with a therapist., Data Collection and Analysis: We extracted data in duplicate on the type of subjects, the nature of the self-help materials, the amount of face to face contact given to subjects and to controls, outcome measures, method of randomisation, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least six months follow-up in patients smoking at baseline. We used the most rigorous definition of abstinence in each trial, and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a fixed effects model., Main Results: We identified fifty-one trials. Thirty two compared self-help materials to no intervention or tested materials used in addition to advice. In eleven trials in which self-help was compared to no intervention there was a pooled effect that just reached statistical significance (odds ratio 1.24, 95% confidence interval 1.07 to 1.45) This analysis excluded one trial with a strongly positive outcome that introduced significant heterogeneity. Four further trials in which the control group received alternative written materials did not show evidence for an effect of the smoking self-help materials. We failed to find evidence of benefit from adding self-help materials to face to face advice, or to nicotine replacement therapy. There was evidence from fourteen trials using materials tailored for the characteristics of individual smokers that such personalised materials were more effective than standard manuals (ten trials, odds ratio 1.36, 95% confidence interval 1.13 to 1.64) or no materials (three trials, odds ratio 1.80, 95% confidence interval 1.46 to 2.23). A small numbers of trials failed to detect benefit from using additional materials or targetted materials., Reviewer's Conclusions: Standard self-help materials may increase quit rates compared to no intervention, but the effect is likely to be small. We failed to find evidence that they have an additional benefit when used alongside other interventions such as advice from a health care professional, or nicotine replacement therapy. There is evidence that materials that are tailored for individual smokers are more effective.

Tobacco smoking is associated with an increased risk for the development of coronary and pulmonary vascular diseases and smoking cessation will greatly reduce this risk. Nicotine replacement and nonnicotine modalities have been used alone and in combination to help in smoking cessation. These treatment modalities appear to be safe in patients with known stable coronary artery disease.

To smokers, nicotine addiction is a powerful vice that is difficult to overcome even with pharmaceutical aids. Relapse rates are high and maintaining a successful quitting strategy is difficult regardless of the method used. Therefore, clinicians should routinely provide positive feedback to help maintain their patients' cessation. Encouraging smoking cessation, selecting appropriate products, and monitoring and supporting patients through their withdrawal symptoms makes for a more complete therapeutic care plan for cessation of tobacco use. In the long term, helping patients to succeed in their cessation treatment has the potential to reduce healthcare costs, save clinicians time and money, and improve morbidity and mortality rates.

Background: Until recently, Dutch general practitioners contributed little to tobacco control. This is due to several factors, among which is the lack of a feasible intervention program for adult smokers. Such a minimal contact behavioral intervention, using the Stage-of-Change concept, is now available. Effectiveness was tested in a randomized trial., Method: Twenty-two general practitioners and their practice assistants were trained in applying the program. In all, 530 smoking patients were enrolled, randomly assigned to either the intervention or the usual treatment condition. Analysis of treatment effects was performed with logistic regression analysis. In a backward stepwise procedure confounding effects of baseline differences were eliminated., Results: At 12-month follow-up, self-reported abstinence rates (including nonrespondents as smokers) differed significantly between intervention subjects and controls: 13.4 vs 7.3% point prevalence (odds ratio 1.51, P < 0.05). An analysis of consecutive abstinence, defined as being abstinent at both 6- and 12-month follow-up, showed that 8.2% of the intervention group compared to 3.1% of the controls had sustained abstinence for more than 6 months (odds ratio 3.04, P < 0.001)., Conclusions: Results indicate that an effective smoking cessation program for use in Dutch general practice, already shown to be feasible, is now available. Outcomes are generally consistent with recent international literature., (Copyright 2001 American Health Foundation and Academic Press.)

Background: Standard, generic self-help materials have been largely ineffective as behavioral treatments for smoking cessation. In contrast, self-help programs tailored to the needs of specific smokers have shown promise in facilitating quitting., Objective: To evaluate the incremental efficacy of the Committed Quitters Program (CQP), a set of computer-tailored materials offered to purchasers of nicotine polacrilex gum, compared with a briefuntailored user's guide and audiotape, both as supplements to nicotine replacement therapy., Methods: We conducted a randomized, open-label trial with 3 parallel arms. Subjects were smokers who purchased 2- or 4-mg nicotine polacrilex gum and called the CQP toll-free enrollment line. Three thousand six hundred twenty-seven subjects consented to participate in 1 of 3 study arms: (1) those receiving the CQP materials (CQP group, n= 1,217), (2) those receiving CQP materials and an outbound telephone call (CQP + C group, n= 1,207); and (3) those receiving no supplemental intervention beyond the user's guide and audiotape that were prepackaged with the nicotine polacrilex gum (UG group, n= 1,203). Twenty-eight-day continuous abstinence rates were assessed by telephone interviews at 6 weeks and 10-week continuous rates at 12 weeks into treatment., Results: Abstinence rates among respondents at the 6- and 12-week assessments were significantly higher for the CQP (36.2% and 27.6%) and CQP + C (35.5% and 27.3%) groups compared with the UG group (24.7% and 17.7%) at both intervals. The quit rates for the CQP and CQP + C groups were almost identical., Conclusions: The CQP proved to be an effective behavioral treatment, enhancing quit rates over and above nicotine replacement therapy and a brief untailored written guide and audiotape.

The best available data show smoking to be by far the most important cause of disease and death in our society, contributing to an average of 1000 deaths every day. Although a large majority of current smokers express a desire to quit, the majority of "self-help" attempts to quit are not successful. Further, most smokers indicate never having received advice on cessation from healthcare providers. The combination of pharmacotherapy and behavioral interventions, even on a minimal level, have been shown to be effective in cessation. Such strategies are certainly highly cost-effective, given the enormous costs to society of smoking-related illnesses. Therefore, it is important that all healthcare providers provide at least some form of smoking cessation programs for their patients.

Objective: Case studies suggest cigarette abstinence may precipitate a major depressive episode. This study examined the incidence and predictors of major depression in the 12 months after treatment for smoking cessation., Method: Participants (N=304, 172 women) were recruited from two trials of smoking cessation. Both trials provided psychological group intervention, but one group received treatment with nicotine gum and the other was given nortriptyline or placebo. The incidence of major depressive episodes was identified by the Inventory to Diagnose Depression, which was administered at follow-up assessments., Results: The 12-month incidence of major depression after treatment for smoking cessation was 14.1% (N=43). Multiple logistic regression analyses indicated that history of depression, baseline Beck Depression Inventory score, college education, and age at smoking initiation were significant predictors of major depression after treatment. Abstinence at the end of treatment did not significantly predict major depression., Conclusions: Patients who achieved abstinence from smoking showed a risk of developing depressive episodes similar to those who failed to achieve abstinence. As expected, patients who had a history of depression were more likely to experience depressive episodes after treatment for smoking cessation. The 12-month incidence of major depression in this study group was higher than that observed in the general population, but reasons for the elevation were not clear.

Background: Many smokers give up smoking on their own, but provision of materials giving advice and information may assist them and increase the number who quit successfully., Objectives: The aims of this review were to determine the effectiveness of different forms of self-help materials, compared with no treatment and with other minimal contact strategies; the effectiveness of adjuncts to self-help, such as computer generated feedback, telephone hotlines and pharmacotherapy; and the effectiveness of approaches tailored to the individual compared with non-tailored materials., Search Strategy: We searched the Cochrane Tobacco Addiction Group trials register. Date of the most recent search September 1999., Selection Criteria: We included randomised trials of smoking cessation with follow-up of at least six months, where at least one arm tested a self-help intervention. We defined self-help as structured programming for smokers trying to quit without intensive contact with a therapist., Data Collection and Analysis: We extracted data in duplicate on the type of subjects, the nature of the self-help materials, the amount of face to face contact given to subjects and to controls, outcome measures, method of randomisation, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least six months follow-up in patients smoking at baseline. We used the most rigorous definition of abstinence in each trial, and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a fixed effects model., Main Results: We identified forty-five trials. Twenty seven compared self-help materials to no intervention or tested materials as an adjunct to advice. In nine trials in which self-help was compared to no intervention there was a pooled effect which just reached statistical significance (odds ratio 1.23, 95% confidence interval 1.02 to 1.49). There was no evidence of benefit from adding self-help materials to face to face advice, or to nicotine replacement therapy. There was evidence from eight trials using materials which were tailored for the characteristics of individual smokers that such personalised materials were more effective than standard materials (odds ratio 1.41, 95% confidence interval 1.14 to 1.75). Adding follow-up telephone calls from counsellors also appeared to increase quitting (odds ratio 1.62, 95% confidence interval 1.33 to 1.97). One trial of offering access to a hotline also showed an effect., Reviewer's Conclusions: Self-help materials may provide a small increase in quitting compared to no intervention. There is no evidence that they have an additional benefit over other minimal interventions such as advice from a health care professional, or nicotine replacement therapy. There is evidence that materials tailored for individual smokers are more effective.

Background: Data on prevalence of cigarette smoking by hospital employees are limited in Australia, but anecdotal evidence suggests that many health sector employees continue to smoke despite abundant evidence regarding the harmful effects of this habit. Nicotine is an addictive drug and arguably this should be known better in the health industry than in any other industry. Despite having this knowledge at their disposal, health sector employers rarely provide assistance to employees, relying instead on restrictive policies to reduce smoking in the workplace., Methods: To assist employees to quit smoking, we instituted a medium intensity Stop Smoking Programme, run by a clinical pharmacist offering nicotine patches and support on a weekly basis. A principal aim of the service was to redress the imbalance between the availability of cigarettes and the most effective nicotine replacement therapy, the trandermal nicotine patch. Following 18 months operation of this service, we surveyed hospital employees to ascertain smoking rates and views on smoking cessation in this South Australian teaching hospital., Results: In the first 18 months of operation, 111 staff members availed themselves of the service. At the first follow up period (three months), 21 were not contactable, 29 were successful in not smoking and 61 were still smoking. Six of the 29 who were not smoking at three months resumed smoking by six months, and a further four resumed smoking by 12 months. At the time of this report, 12 of the remaining 19 non smokers had completed two years since quitting and a further three of these had resumed regular smoking by this time. The cost of providing the service was modest at approximately $180.00 per known successful quitter. Results from the survey showed that 12.4% of hospital employees were regular smokers. Smoking prevalence was not equally distributed with female employees being twice as likely to smoke as their male counterparts and employees in the catering department having the highest smoking prevalence (23.8%)., Conclusions: Although the prevalence of cigarette smoking by employees of this teaching hospital is lower than for the general community, health sector employers can reduce smoking prevalence further by providing assistance to their employees to quit smoking. The Stop Smoking Programme we describe is effective and could be replicated by other hospitals and similar organisations.

The effects of using several nicotine replacement treatments on self-reported withdrawal symptoms and side effects during 2-day periods of smoking cessation, with 5 days of ad lib smoking between cessation days, were evaluated. Participants (N = 18) experienced the following conditions: nicotine gum, 24-hr patch, 16-hr patch, 24-hr patch plus gum, double 24-hr patch, and no nicotine replacement. The present study found morning urge to smoke was greater during the 16-hr than during the 24-hr patch condition. Double-patch use resulted in significantly greater insomnia than the smoking baseline and 16-hr patch conditions. The no medication and gum alone conditions resulted in similar withdrawal symptoms, and both tended to result in greater reported withdrawal symptoms than the smoking baseline condition. There were no significant withdrawal symptom differences between the 24-hr, patch-gum, and double-patch conditions. The 24-hr and double-patch conditions were preferred by two thirds of the participants (6 each).

Cigarette smoking remains the single most preventable cause of death in the United States. Nurses can be instrumental in assisting patients in quitting. A prospective quasi-experimental design was employed to investigate the differences in quit rates, adverse drug reactions, time to relapse, and secondary factors that contribute to smoking cessation in two groups of patients who attended a group program and used either a nicotine patch or nicotine gum. Although there were no significant differences in quit rates at one year, the patch group showed a significant increase in short-term quit rates and a decrease in adverse reactions as well as a longer time to relapse. Older patients demonstrated a longer time to relapse while a high degree of nicotine dependency was correlated with a shorter time to relapse.

Drug and nondrug interventions used in treating nicotine dependence are reviewed. Tobacco use is the leading preventable cause of death in the United States. Risks of smoking-related disease and death decline sharply when smokers quit, but 26% of Americans continue to smoke. Most smokers find it extremely difficult to quit smoking because of their nicotine addiction. Nonpharmacologic interventions used to promote smoking cessation include behavioral therapy, setting a specific date for quitting, receiving advice to quit from a health care professional, follow-up visits to review progress, self-help approaches, group counseling, filtration devices, hypnosis, and acupuncture. The efficacy of these approaches ranges from substantial to almost nil. The only pharmacologic agent with FDA-approved labeling for use in smoking-cessation therapy is nicotine. When used in conjunction with appropriate nonpharmacologic interventions, nicotine-replacement therapy roughly doubles the rate of quitting obtained with placebo. Nicotine-replacement therapies consist of nicotine transdermal (patch) systems and nicotine chewing gum. The nicotine patch is the first-line replacement therapy because it is effective when accompanied by only minimal (as opposed to more intensive) nonpharmacologic interventions and because it is easier to use and comply with than gum. Clonidine, antidepressants, and buspirone require further study to determine what role, if any, they should play in the treatment of nicotine dependence. The stages of smoking cessation are precontemplation, contemplation, action, and maintenance; interventions are selected on the basis of the stage the smoker is in. Nicotine dependence is difficult to treat, but there are aids that boost a smoker's chances of quitting. Nicotine patches and chewing gum offer the most effective pharmacologic options, especially when combined with behavioral interventions and counseling.

Smoking and smokeless tobacco can cause significant damage to the oral cavity, including life-threatening cancers. Consequently, dentists and their office staffs should and can play an influential role in advising their patients to quit using tobacco. The National Cancer Institute has developed the "Four A's" approach to tobacco-cessation counseling: (1) ask about tobacco use; (2) advise to quit; (3) assist with quitting; and (4) arrange for follow-up. With minimal expenditures of treatment time, the dentist and office staff can encourage patients to quit using tobacco through nonconfrontational messages that point out the clinical damage caused by smoking and smokeless tobacco. Besides behavior modification, dentists can prescribe several Food and Drug Administration-approved pharmaceutical agents as adjuncts to a tobacco-cessation program. Nicotine polacrilex (gum) and nicotine transdermal systems have proven very useful in helping tobacco users quit their habit.

The extent and predictors of weight change were assessed among sustained nonsmoking special intervention participants in the Lung Health Study. The intervention included a 12-session group program and 2-mg nicotine gum. At 12 months, female sustained quitters (SQs; n = 248) had gained a mean of 8.4% (5.3 kg) of their baseline weight, whereas male SQs (n = 443) had gained 6.7% (5.5 kg). By 24 months, female SQs had gained 9.8% of their baseline weight compared with 6.9% for men. Nicotine gum usage delayed a portion of the weight gain. Multiple regression analysis showed that weight gain at 12 months was associated with a higher baseline salivary cotinine level, a lower baseline body mass index, drinking less alcohol per week, and a lower cotinine level at 12 months (indicating less or no nicotine gum use). We conclude that moderate weight gain is a long-term consequence of smoking cessation--a portion of which can be delayed with 2-mg nicotine gum.

This article deals with the topic of nicotine replacement drugs and their use in smoking cessation. Questions frequently arise as to their prescription by dentists. Provided patients are carefully selected on the basis of medical and psychological profiles, there is no ethical or legal contraindication to dentists prescribing these aids. This article reviews the current literature and answers commonly asked questions concerning these effective drugs.

In a retrospective program evaluation analysis, we compared abstinence rates in 78 smokers participating in a 2-, 3-, or 6-week clinic-based behavioral-pharmacological smoking cessation program. The three treatment formats consisted of six sessions that varied in session frequency. Retention and end-of-treatment smoking cessation rates were best in the medium-frequency (3-week) and high-frequency (2-week) treatment session formats. One-year follow-up abstinence rates were highest in the medium-frequency format, and lowest in the high-frequency format. A significant patient-treatment interaction effect was found for pretreatment smoking rate. Individuals with lower pretreatment smoking rates benefited most with respect to end-of-treatment cessation rates from the medium- and high-frequency treatment session format. However, this effect was not significant at the 1-year follow-up. The need for prospective research and patient-to-treatment matching implications in smoking cessation programs are discussed.

Background: This paper investigates individual patient characteristics predicting differential response to each of three physician-delivered smoking interventions after 6 months., Methods: Participants were 1,286 currently smoking patients seen by 196 medical and family practice residents in five primary care clinics affiliated with the University of Massachusetts Medical School. Of the participants, 57% were female, 92% were white, their average age was 35 years, and they smoked an average of 23 cigarettes per day. Physicians were trained to provide the following interventions: advice only (AO), a brief (< 10 min) patient-centered counseling intervention (CI), and counseling plus prescription of the nicotine-containing gum Nicorette (CI+NCG). The CI+NCG condition included NCG only when appropriate and if acceptable to the patient. Patients were randomized to one of these three physician-delivered intervention conditions., Results: Overall, stratified univariate analyses revealed that AO produced consistently lower cessation rates across most subgroups (generally 9-13%) but was somewhat more effective for certain groups of lighter smokers. Relative to AO, CI was somewhat more effective (about 20-24%) for less addicted smokers, for those with more previous quit attempts, and for those with fewer close associates who smoke, but generally failed to produce higher quit rates for harder core smokers or for women. CI+NCG had an overall pattern of greater effectiveness for both more addicted and less addicted smokers, with the highest absolute levels of cessation (about 27-30%) among less dependent smokers. Women in this group had cessation rates (20.6%) comparable to those of men (23.6%). Condition-stratified logistic regression analyses, controlling for a wide range of covariates, revealed associations similar to those observed in the univariate analyses: An overall logistic model in which intervention conditions were fitted as dummy variables produced the following significant main effects: sex, years smoked, contact with other smokers, symptoms, and CI+NCG condition. Significant interactions were observed for both CI and CI+NCG and smoking when feeling too ill to continue normal activities and CI+NCG and amount smoked., Conclusions: We observed significant main effects on cessation of variables related to addiction, sex, social factors, and physician counseling interventions. Specific interactions were observed between reported smoking when feeling ill and each of the counseling interventions as well as by amount smoked in the CI+NCG condition.

Smokers (N = 99) were randomly assigned to one of three conditions: nicotine gum (NG), nicotine gum plus psychological treatment (NG-PT), and nicotine gum plus psychological treatment and partner support (NG-PT-PS). Data were collected at Weeks 0, 4, 12, 26, and 52 from study start. Contrary to expectations, NG-PT-PS and NG-PT failed to increase abstinence rates. Subjects who were closer to their support partners had significantly lower abstinence rates with NG-PT-PS than with the other conditions, although not significantly at Weeks 26 and 52. Treatments without partner participation (NG-PT and NG) were significantly more effective for subjects who had an extremely close support partner outside the treatment setting than for those who did not at all weeks. The role of social support in smoking treatment is discussed.

Our purpose in this randomized clinical trial was to compare a two-visit smoking cessation intervention by family physicians with the same intervention supplemented by additional follow-ups. Forty-one southern Ontario family physicians volunteered for the study and subsequently participated in a four-hour training program on smoking cessation techniques. Physicians advised patients who smoked and indicated an interest in attempting to quit with the help of their physician to stop smoking at the end of a regularly scheduled visit. Physicians instructed patients to make a specific appointment for an evaluation of their smoking habits. Six hundred forty-seven patients returned for that assessment and were than randomized into either the two-visit intervention group (with risk assessment, support, the setting of a cessation date, self-help literature, and a prescription for nicotine gum, where appropriate) or into the other intervention group (with the same maneuvers as well as the offer of four more supportive follow-up visits). We found no statistically significant difference in one-year, biochemically validated, sustained cessation rates between the group offered the long-term follow-up visits (12.5%) and the group given the brief intervention (10.2%). The 95% confidence interval on the difference between the groups was 2.8% in favor of the brief intervention group to 7.3% in favor of the group offered follow-up. The results do not support the value of long-term follow-up visits for smokers.

A study with a 2 x 2 factorial design was performed to evaluate the effectiveness of acupuncture, of nicotine gum and the effect of the association on smoking cessation. After a one-year follow-up period, the success rates were in the same order of magnitude for nicotine gum (active treatment: 10%, placebo: 8%) group and for acupuncture (active treatment: 8%, placebo: 10%) group.