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Smoking reduction treatment with 4-mg nicotine gum: a double-blind, randomized, placebo-controlled study.

BACKGROUND: Smoking reduction may provide a harm-reduction alternative treatment for smokers who are not ready to quit smoking. This study evaluated the efficacy of nicotine gum in helping smokers reduce or quit smoking. METHODS: This randomized, double-blind, placebo-controlled trial involved 364 smokers who were not ready to quit but were willing to reduce their smoking intensity. Participants received either 4-mg nicotine gum (n = 184) or placebo gum (n = 180) as desired for up to 12 months. The primary outcome was sustained smoking reduction, which was defined as a decrease in daily cigarette consumption of at least 50% compared with baseline. Secondary measures included point-prevalence abstinence, intention to quit, and cardiovascular risk markers. RESULTS: At 4 months, the sustained smoking reduction rate in the nicotine gum group was twice that of the placebo group (15.8% versus 6.7%, P = .008). Point-prevalence abstinence was 6.6% for the nicotine gum group and 2.2% for the placebo group (P = .07). At 13 months, there was a significant difference in the smoking reduction rate for the nicotine (8.2%) and placebo (2.8%) groups (P = .036). At month 13, the abstinence rates were 12% and 4.5% for the nicotine and placebo groups, respectively (P = .012). Concomitant use of nicotine gum and cigarette smoking was well tolerated. Carbon monoxide levels decreased significantly (P = .01). CONCLUSION: Nicotine gum may be an efficacious harm-reduction alternative for smokers who are not ready to quit and may promote smoking cessation, the ultimate goal in the treatment of tobacco dependence.

Administration, Oral↗

Smoking reduction and biomarkers in two longitudinal studies.

AIMS: To measure reduction in exposure to smoke in two population-based studies of self-reported smoking reduction not using nicotine replacement. DESIGN: Cross-sectional analyses of biomarkers and smoking. SETTING: Data from two time-points in the Copenhagen City Heart Study (CCHS), 1981/83 and 1991/94, and the Copenhagen Male Study (CMS) in 1976 and 1985/86, respectively. PARTICIPANTS: There were 3026 adults who were smokers at both time-points in the CCHS and 1319 men smoking at both time-points in the CMS. MEASUREMENTS: Smoking status and tobacco consumption were assessed by self-completion questionnaire. Measurements of biomarkers of smoke intake were taken at the second time-point in the two studies: expired-air carbon monoxide (CO) in the CCHS and serum cotinine in the CMS. Biomarker levels in medium (15-29 g tobacco/day) and heavy (> 30 g/day) smokers at the first time-point who later reported a reduction in cigarettes per day of 50% or more without quitting were compared with continuing medium, heavy and light smokers (1-14 g/day) using linear regression. Sex (CCHS only), age, self-reported inhalation of smoke, duration of smoking, type of tobacco and amount smoked were included as covariates in multivariate models. FINDINGS: Heavy smokers who reduced did not show lower levels of biomarkers at follow-up. Medium smokers who reduced showed a reduction in cotinine but not CO. The reduction in cotinine was not commensurate with the reported reduction in consumption. CONCLUSIONS: Long-term reductions in self-reported tobacco smoking are probably associated with, at best, modest reductions in smoke exposure.

Adult↗

Smoking cessation--but not smoking reduction--improves the annual decline in FEV1 in occupationally exposed workers.

INTRODUCTION: Individuals exposed both to cigarette smoke and respiratory pollutants at work incur a greater risk of development of airway hyperresponsiveness (AHR) and accelerated decline in forced expiratory volume in 1 s (FEV1) than that incurred by subjects undergoing each exposure separately. We examined whether smoking cessation or smoking reduction improves AHR and thereby slows down the decline in FEV1 in occupationally exposed workers. METHODS: We examined 165 workers (137 males and 28 females) participating in a smoking cessation programme. Nicotine tablets were used for smoking cessation or smoking reduction. Respiratory symptoms were assessed by questionnaire, FEV1 by spirometry and AHR by methacholine challenge test. At 1 year, subjects were classified into quitters, reducers, or continuing smokers. RESULTS: Sixty-seven subjects completed the study (32 quitters; 17 reducers; 18 continuing smokers). Respiratory symptoms improved markedly in quitters (P<0.001 for all comparisons) and less so in reducers (P values between 0.163 and 0.027). At 1 year, FEV1 had slightly but significantly improved in quitters (P=0.006 vs. smokers; P=0.038 vs. reducers) and markedly deteriorated in reducers and continuing smokers. Concurrent, 1-year change in AHR did not differ significantly among the groups. CONCLUSION: In occupationally exposed workers, stopping smoking markedly improved respiratory symptoms and, in males, slowed the annual decline in FEV1. Smoking reduction resulted in smaller improvements in symptoms but deterioration in FEV1. These findings were independent of AHR. While smoking cessation should remain the ultimate goal in workplace cessation programmes more studies are necessary to better ascertain the benefits of smoking reduction.

Adult↗

The impact on infant birth weight and gestational age of cotinine-validated smoking reduction during pregnancy.

OBJECTIVE: To evaluate the impact of cotinine-confirmed smoking reduction during pregnancy on infant birth weight and gestational age at birth. DESIGN: Group analyses from a prospective, randomized smoking-cessation intervention trial using cotinine levels to assess smoking cessation and reduction. SETTING: Four maternity clinics of Jefferson County Health Department in Birmingham, Ala. PATIENTS: A total of 803 pregnant smokers and 474 never smokers with a fetal gestational age of 32 weeks or less at the first prenatal visit to a clinic. MAIN OUTCOME MEASURES: Infant birth weight and gestational age at birth. RESULTS: Infants who were born to women who quit smoking (quitters) had the highest mean birth weight (3371 +/- 581 g), followed by infants who were born to women who did not change smoking behavior (no changers) (3043 +/- 587 g). The mean infant birth weight of infants born to the quitters, adjusted by mother's age, race, height, weight at baseline, and gestational age at delivery was 241 g heavier than that among the no changers (P = .0008) and 167 g heavier than the reducers (P = .04). The adjusted mean infant birth weight of infants born to the reducers was 92 g heavier than that among the no changers (P = .08). White reducers with baseline cotinine levels greater than 100 ng/mL had infants who were 241 g heavier than did white no changers. A 220-g difference was also seen in black reducers with a baseline cotinine level of 100 ng/mL or less. Although smoking cessation increased infant gestational age at delivery by 1 week, smoking reduction had little effect. CONCLUSION: Cotinine-validated smoking reduction rates were positively associated with an increase in infant birth weight. While smoking cessation must continue to be the primary objective for pregnant smokers, specific intervention methods should also be directed toward smoking reduction for women who cannot quit.

Biomarkers↗

Techniques used by smokers during contingency motivated smoking reduction.

This study investigated the smoking reduction strategies used by smokers who were not enrolled in formal treatment. Twenty-four smokers were interviewed following a study in which they were contingently reinforced for reductions in alveolar carbon monoxide levels but not provided with specific reduction strategies. Results indicated that smokers who consumed more food or liquids to avoid smoking and/or who avoided other related substances such as alcohol and coffee were more successful in reducing carbon monoxide levels than subjects who did not use these techniques (p less than 0.05). Conversely, subjects who stated that they attempted to reduce without a specific plan were less successful in reducing carbon monoxide levels (p less than 0.05).

Adult↗

Smoking reduction in a population-based cohort.

OBJECTIVE: To describe the factors associated with smoking reduction in a population-based cohort study in Cornella de Llobregat (Barcelona, Spain). MATERIAL AND METHODS: We used data from the Cornella Health Interview Survey Follow-up Study (n = 2,500). We included for the analysis those subjects who declared to be daily smokers at baseline (1994) and continued smoking after eight years of follow-up (n = 234). We considered as operational definition of reduction to reduce > or = 10 cigarettes/day. We calculated the relative risk (RR) of smoking reduction vs. maintain or increase tobacco consumption and 95% confidence intervals (CI) by means of a Breslow-Cox regression model. RESULTS: The average reduction on number of cigarettes among subjects who reduced their tobacco consumption was similar in men and women (13 cigarettes/day). The consumption intensity and self-perceived health are the characteristics associated with reduction: smoking reduction was associated with being a smoker > 20 cigarettes/day (RR = 3.25; 95% CI: 1.69-6.25) and individuals who declared having a suboptimal health showed a 3-fold risk of reducing smoking (RR = 3.13; 95% CI: 1.52-6.43). CONCLUSION: Heavy smokers and smokers with poor health are those smokers more likely to reduce their tobacco consumption. Specific actions targeting them could lead to increase reduction and even smoking cessation.

Adult↗

Practical experiences in smoking reduction and cessation.

Tobacco use is a major cause of cardiovascular, respiratory and oncological disease. Quitting smoking significantly benefits health, but for highly dependent smokers, unable to overcome their nicotine dependence, the concept of smoking reduction as a method of harm reduction is gaining ground. The University Hospital of Basle, Switzerland, has run double-blind, placebo-controlled smoking cessation and smoking reduction studies: the CEASE trial evaluated the efficacy of the nicotine patch in achieving abstinence, and the Rosette study is evaluating the efficacy and tolerability of the nicotine oral inhaler in smokers who do not wish to quit. Smokers were instructed either to quit smoking (CEASE) or to reduce cigarette consumption by > 50% (Rosette). In both studies, success rates for active treatment versus placebo at 4 months demonstrated that nicotine replacement therapy (NRT) is effective in achieving both smoking cessation and reduction. Current approaches to smoking cessation and reduction at our clinic are discussed. Combination NRT rather than monotherapy is commonly used to achieve both smoking reduction and cessation. Treatment appears to be most effective if subjects are allowed to select their preferred NRT product. There are clear differences in patient populations aiming to quit or reduce, the cessation population being more motivated. Smoking cessation remains the ultimate aim but, if unfeasible, a significant reduction in cigarette consumption is a valid goal.

Double-Blind Method↗

Influence of long-term smoking reduction on health risk markers and quality of life.

We have recently published efficacy and safety data of a study using an oral nicotine inhaler in smoking reduction. The current analysis was undertaken to assess the secondary objectives of the trial: the influence of long-term smoking reduction on health risk markers. Four hundred healthy volunteers, unable or unwilling to stop smoking immediately, were enrolled in a double-blind, randomized, placebo-controlled trial in smoking reduction; 310 were evaluable up to 2 years. Participants were randomized to active or placebo inhalers as needed for up to 18 months, with subjects encouraged to reduce their smoking as much as possible; counseling took place over a 2-year period. For the current prospective cohort study, the number of daily cigarettes, carbon monoxide (CO), cotinine, cardiovascular risk factors, pulmonary function tests, and quality of life were compared between successful reducers (n = 25) and unsuccessful reducers (control group, n = 285). Success was defined as a reduction of daily cigarettes of at least 50% from week 6 to 2 years, verified by a decrease in exhaled CO at all visits compared with baseline. At 2 years, successful reducers showed a significantly greater decrease in cotinine levels (60% vs. 1%, p < 0.001), cholesterol/high-density lipoprotein (HDL) ratios (-2.42 vs. -1.67, p = 0.025), hemoglobin concentrations (-5.67 vs. -1.34 g/l, p = 0.023), pulse rate (-3.7 vs. +1.0 bpm, p = 0.043), and significantly improved general health score (9.40 vs. 2.34, p = 0.049); whereas no difference was found in forced expiratory volume during 1 s (FEV1) and forced vital capacity (FVC) compared with controls. The benefits of long-term smoking reduction of at least 50% of daily cigarettes were not offset by compensatory smoking, and the marked decrease in markers of smoke exposure had a positive influence on several cardiovascular risk markers and quality of life assessments.

Adult↗

Predictors of smoking reduction and cessation in a cohort of danish moderate and heavy smokers.

BACKGROUND: The aim of this study was to examine the extent and gender distribution of unassisted tobacco reduction and cessation in a cohort of moderate and heavy smokers and to identify possible predictor variables associated with these changes in smoking behavior. METHODS: This was a prospective population study of 3,791 moderate and heavy smokers, 15 g tobacco/day or more, who were enrolled in the Copenhagen City Heart Study in 1976-1978 and attended a reexamination 5 years later. Data on smoking behavior were collected at baseline and follow-up. Smoking reduction was defined as a decrease in mean daily tobacco consumption of 10 g or more. Using multivariate logistic regression, subjects who reported reduced smoking or who reported smoking cessation were compared with subjects who continued the habit unchanged. RESULTS: After 5 years 13% of the men and 9% of the women had reduced their tobacco consumption, and 9 and 7%, respectively, had quit altogether. Smoking reduction was strongly associated with high tobacco consumption (25+ g/day) at baseline and also with severely impaired lung function (FEV(1) <50% predicted) and overweight (BMI >25). Predictors of smoking cessation included impaired lung function and a tobacco consumption of 15-24 g/day. Additional determinants of smoking reduction and cessation such as inhalation habits and sociodemographic variables differed by gender. CONCLUSIONS: Several predictors of smoking reduction and cessation were identified, indicating that these subgroups of smokers differ substantially from continuing smokers. This should be taken into account when assessing potential health benefits from these changes in smoking behavior.

Adult↗

Addressing regulatory barriers to licensing nicotine products for smoking reduction.

This paper examines the current regulatory obstacles to extending the permitted use of NRT, and to include smoking reduction ways of addressing these. There are major differences between different countries in regulations concerning NRT. These differences appear to be due to different attitudes to cigarette smoking as an issue and different preconceptions about nicotine as an addictive and potentially toxic drug. The paper considers how existing WHO and American Psychiatric Association definitions of mental disorders may be used in submitting proposals for use of NRT as an aid to smoking reduction and how concerns over safety and abuse and dependence liability can be addressed. It also examines what new evidence may be needed. Coordinating the efforts of the pharmaceutical industry, clinicians and researchers will probably be important in moving regulatory authorities further in the direction of accepting NRT for widespread use in smoking reduction.

Attitude to Health↗

Does smoking reduction result in reduction of biomarkers associated with harm? A pilot study using a nicotine inhaler.

The aim of the study was to determine if smoking reduction using a nicotine inhaler in heavy cigarette smokers who wanted to reduce but not stop smoking results in decreased levels of known biomarkers of harm. The study design was a one-sample within-subject comparative open-label study of 23 (10 male and 13 female) subjects using a nicotine inhaler to reduce smoking, with follow-up at 24 weeks. A structured protocol was used with a smoking-reduction schedule from 40 or more cigarettes per day to 10 cigarettes per day by week 9. Behavioral counseling was provided by a research assistant and ad lib use of the nicotine inhaler for 12 weeks was permitted. Blood thiocyanate, cotinine, 4-aminobiphenyl hemoglobin adducts; urine NNAL and NNAL-glucuronide; and expired air carbon monoxide were measured. On average, the subjects were able to reduce their smoking by over 50% at week 12, but only two were able to reduce to 10 cigarettes per day. The reported reduction in smoking was not associated with a consistent reduction in the biomarkers. There was no reduction in the NNAL, 4-aminobiphenyl hemoglobin adducts nor carbon monoxide levels of expired air. There was a significant reduction of NNAL-glucuronide and the sum of NNAL and NNAL-glucuronide but only at week 24. Thiocyanate levels increased. Before widely promoting harm reduction as a treatment strategy for heavy smokers, more research needs to be performed to prove conclusively that such smokers who want to reduce but not stop can actually reduce and maintain their smoking rate at a level which is likely to reduce harm. It also needs to be determined whether a reduction in the smoking rate translates into reduction of harm. At the present, for heavy smokers, an abstinence approach seems to be more scientifically sound.

Administration, Inhalation↗

[Smoking reduction is associated with a reduced the risk of lung cancer--a secondary publication].

The purpose of this cohort study with up to 31 years of follow-up of 19,714 persons from three Danish population-based studies was to analyse the association between smoking reduction and lung cancer risk. Information on smoking habits and changes in these were linked to the Danish Cancer Registry for incident lung cancers and analysed with Cox regression. Results showed that compared to sustained heavy smokers, smoking reduction by at least 50% reduced lung cancer incidence by 27%. We conclude that smoking reduction is associated with a significantly reduced risk of lung cancer.

Adult↗

Motivating smoking reductions by framing health information as safer smoking tips.

Explored the hypothesis that framing health information as safer smoking tips might motivate change in cigarette smokers. Daily smokers were randomly assigned to a control condition or to an intervention condition in which respondents were asked if they knew about a range of different safer smoking tips. Respondents (43 daily smokers, 18 years or older, 58% male) who received safer smoking tips reported a small reduction in the number of cigarettes smoked (p=.05) by the 3-month follow-up as compared to respondents in the control condition. This pilot result is encouraging but requires replication before considering the value of including safer smoking tips in health messages for smokers in the general population.

Adolescent↗

The feasibility of smoking reduction: an update.

AIM: To update conclusions of a previous review of smoking reduction on the extent to which (1) smokers spontaneously reduce their smoking, (2) smokers who try to quit and fail return to smoking less, (3) smokers can substantially reduce and maintain reductions via pharmacological and behavioral treatments and (4) smokers compensate when they reduce. METHOD: Qualitative systematic review. DATA SOURCES: Systematic computer searches and other methods. STUDY SELECTION: Published and unpublished studies of smokers not trying to stop smoking. We located 13-26 studies for each of the four aims. DATA EXTRACTION: The first author entered data with confirmation by second author. DATA SYNTHESIS: Due to the heterogeneity of methods and necessity of extensive recalculation, a meta-analysis was not feasible. RESULTS: Few daily smokers spontaneously reduce. Among those who try to stop smoking and relapse, some return to reduced smoking but whether they maintain this reduction is unclear. Nicotine replacement (and perhaps behavior therapies) can induce smokers not interested in quitting to make significant reductions in their smoking and maintain these over time. Some compensatory smoking occurs with reduction but significant declines in smoke exposure still occur. CONCLUSIONS: These results indicate that reduction is feasible when aided by treatment. Whether reduction should be promoted will depend on the effect of reduction on health outcomes and future cessation.

Adolescent↗

Long-term follow-up (3-4 years) of treatment for smoking reduction.

The present paper reports the 3- and 4-year follow-ups of two smoking reduction clinics (n = 103) employing a comprehensive, non-aversive, behavioral treatment using stimulus control and self-control techniques. Most of the data were gathered via phone contact, while some clients were interviewed in person with corroborative carbon monoxide measurements taken at that time. While the general findings were similar to those reported for other long-term follow-ups of smoking programs, unlike earlier reports, the overwhelming majority of subjects were contacted (an average of 90% for all follow-up periods). The average percentage of baseline for smoking subjects was equal to 56% and average percentage abstinent equal to 24% at final follow-up. Data are also presented which suggest greater attention be paid to the potential efficacy of controlled smoking when assessing the effectiveness of smoking reduction programs.

Adult↗

Short-term smoking reduction is associated with reduction in measures of lower respiratory tract inflammation in heavy smokers.

The beneficial effect of short-term smoking reduction in reducing lower respiratory tract inflammation was assessed in 15 healthy heavy smokers. All underwent fibreoptic bronchoscopy and bronchoalveolar lavage and were then treated with at least 20 mg of nicotine gum daily. Self-reported cigarette consumption decreased from 50.7 +/- 2.3 to 18.8 +/- 1.5 (p less than 0.001) cigarettes daily, and expired CO decreased from 48.5 +/- 2.5 to 27.3 +/- 2.5 ppm (p less than 0.001). After two months, repeat bronchoscopy and bronchoalveolar lavage revealed that bronchial inflammation, as assessed by direct inspection, neutrophilia of bronchial lavage fluid, and the number of alveolar macrophages, the number of alveolar neutrophils and the concentration of neutrophil elastase alpha 1-antiprotease complex in alveolar lavage fluid, had improved significantly. The present study suggests that smoking reduction may be associated with an improvement in lower respiratory tract inflammation in heavy smokers and may, if persistent, be an alternative for smokers who cannot, or do not wish, to quit.

Adult↗

Contingent payment procedures for smoking reduction and cessation.

We assessed the ability of a combined contingent reinforcement and intensive monitoring procedure to promote and sustain temporary smoking cessation among 34 hired research volunteers, and the ability of a smoking reduction test to predict the subsequent initiation of abstinence. During the 5-day cutdown test, subjects were paid from $0 to $6 per day depending on the extent of reduction from baseline CO levels. During the abstinence test, breath samples were obtained three times daily and subjects were paid $4 for each CO reading less than or equal to 11 ppm. Sixty-eight percent of subjects initiated abstinence. Of the breath samples collected during the abstinence test (91% of scheduled samples), 96.5% were less than or equal to 11 ppm and 80.5% were less than or equal to 8 ppm. Subjects who earned more money during the cutdown test were more likely to abstain (r = -0.51, p less than .001). Contingent reinforcement and intensive monitoring procedures appear to have usefulness for analog studies of smoking reduction and cessation.

Adult↗

The worksite environment as a cue to smoking reduction.

With a modified version of the Health Belief Model as the conceptual framework, the hypothesis that exposure to a worksite health-promoting environment acted as a cue to smoking reduction among 310 smokers was tested with a quasi-experimental design. Using path analysis (LISREL), the total effects on posttest smoking were decomposed. Results showed exposure to the health-promoting environment had statistically significant direct and indirect effects on posttest smoking. The indirect effect was through the posttest perceived barriers variable. The LISREL model explained 74% of the variance in smoking reduction and fit the data satisfactorily. The importance of developing the worksite as a health-promoting force is discussed.

Adult↗