Predictors of success for smoking cessation at the workplace: a longitudinal study.

BACKGROUND: The effectiveness of worksite interventions to reduce smoking is debatable. OBJECTIVES: A comprehensive smoking cessation intervention was implemented in a community of more than 17,000 employees at three different health care companies. The primary endpoint was abstinence at 24 months (self-reported and confirmed by exhaled carbon monoxide ≤ 6 parts per million). Predictors of long-term abstinence were analysed by multivariable regression analysis. METHODS: The study was designed as an investigator-initiated and investigator-driven, open, multicentre, cohort study; 887 smokers were enrolled in the programme. The intervention included intensive individual counselling as well as nicotine replacement and/or bupropion according to individual preferences. Re-interventions for relapse were offered during the 24-month follow-up. RESULTS: The abstinence rate was 37% at 24 months and did not differ among the various medication groups (p > 0.05 for all). Predictors of successful cessation were higher age (odds ratio, OR 1.47, 95% confidence interval, CI 1.08-2.00, p < 0.01), breathlessness on exertion (OR 2.26, 95% CI 1.1-4.9, p = 0.03), and a higher educational level (OR 1.81, 95% CI 1.06-3.09, p = 0.03). Higher Fagerström (OR 0.76, 95% CI 0.59-0.97, p < 0.01) and craving scores (OR 0.75, 95% CI 0.63-0.89, p < 0.01), chronic sputum production (OR 0.52, 95% CI 0.31-0.87, p = 0.01) and use of antidepressants (OR 0.54, 95% CI 0.32-0.91, p = 0.02) were associated with ongoing smoking. CONCLUSION: A comprehensive smoking cessation intervention at the workplace achieves high, stable, long-term abstinence rates. Elderly, well-educated employees with breathlessness on exertion have higher odds of quitting smoking. In contrast, those with high physical dependency and more intense craving, and those reporting use of antidepressant medication or sputum production have poorer chances to quit.

Niccine®, a nicotine vaccine, for relapse prevention: a phase II, randomized, placebo-controlled, multicenter clinical trial.

INTRODUCTION: A nicotine vaccine could prevent relapse to smoking by hindering blood nicotine from reaching the brain. Niccine® is a nicotine hapten tetanus-toxoid conjugate vaccine. The present study evaluated the clinical efficacy of Niccine for tobacco smoking relapse prevention. METHODS: Cigarette smokers (n = 355) aged 25-50 years were enrolled in a randomized, double-blind, parallel group 1-year trial encompassing 16 visits and 16 telephone calls. Niccine 40 µg or placebo was administered on Days 0, 28, 56, 90, 150, and 210. Between Days 56-98, subjects were treated with varenicline to aid cessation, targeted for Day 70. Only individuals abstinent between Days 90-98 (n = 265) were allowed to continue to 1 year (n = 219). Relapse to smoking was defined as >5 cigarettes within 7 days or since the last contact, or smoking on >5 occasions within 7 days or since the last contact. RESULTS: At 1 year, nonrelapse was 43.3% in the Niccine versus 51.1% in the placebo groups (difference = -7.9%; 95% CI = -20.6% to 4.9%). There was no benefit of Niccine on smoking status at 6 or 9 months, exhaled carbon monoxide levels, time to relapse, abstinence, withdrawal symptoms, or smoking reinforcement. Nicotine antibody levels increased (mean = 1.34 µg/ml; SD = 2.84 µg/ml) in the Niccine group, but were not related to relapse. Adverse events except hypersensitivity and compensatory smoking did not differ between groups. CONCLUSIONS: This nicotine vaccine appeared well tolerated but did not influence trajectories of relapse possibly because of insufficient antibody levels or lack of efficacy of the vaccine concept for relapse prevention.

Should the European Union lift the ban on snus? Evidence from the Swedish experience.

The very low smoking prevalence in Sweden has received considerable attention. Sweden was the only country in Europe to reach the World Health Organizations' goal of less than 20% daily smoking prevalence among adults by year 2000. Only 17% of Swedish men smoke. Some have argued that this has been achieved because Swedes use another form of tobacco instead. Sweden has a high level of use of a moist snuff product called 'snus'. Nineteen per cent of adult men and 1% of women are daily users and the trend is increasing. Epidemiological studies have failed to find evidence that snus causes cancers, including oral cancer. Its adverse effects on the cardiovascular system are debated, but are certainly less than those of smoking. Recent studies among former smokers indicate that many men have quit smoking using snus. Forty-seven per cent of current snus users are former smokers and 28% of ex-smoking used snus at their last attempt to stop smoking. The association between high snus consumption and low smoking prevalence has been debated and challenged. It has been argued that snus may be a gateway to cigarette smoking. Recent data has found that among those starting tobacco use in the form of snus, 20% later go on to smoking while the same risk for those not starting with snus is 43%. On balance, there is reason to believe that having snus available to the Swedish population has been of benefit to public health. Repealing the ban on snus in the rest of the European Union might also have some positive effect, depending on the marketing.

Tobacco harm reduction: the need for new products that can compete with cigarettes.

Over the last 50 years, the concept of tobacco harm reduction has been well established. It is now understood that nicotine itself is not very harmful and nicotine replacement therapy products have been widely used as an aid to quit, reduce to quit or temporarily abstain from smoking for many years. The popularity of the unlicensed electronic cigarette has increased despite an unknown risk profile and sinus use in Sweden provides strong evidence in support of a harm reduction strategy. The regulatory environment around harm reduction has changed in the UK and is continuing to evolve across the globe. The need for more appealing, licensed nicotine products capable of competing with cigarettes sensorially, pharmacologically and behaviourally is considered by many to be the way forward. The significant positive impact on public health that could be gained from encouraging people to switch from cigarettes to licensed medicinal nicotine products cannot be ignored.

Nicotine concentrations with concurrent use of cigarettes and nicotine replacement: a review.

This paper reviews the data on blood nicotine or saliva cotinine concentrations with concomitant smoking and use of nicotine replacement (NR) products. Eleven studies that provided data on blood nicotine concentrations, carbon monoxide in exhaled air, and number of cigarettes smoked were reviewed. At least one day had to be spent on concurrent use of cigarette and NR products. With simultaneous use of smoking and acute NR products (gum and inhaler) the nicotine concentrations were unchanged, whereas they increased (+54%) with nicotine patches. With both types of NR products, the number of cigarettes smoked per day was reduced by approximately 50% and carbon monoxide (CO) by 30%. Where smokers had the intention or received instructions to reduce smoking, a greater reduction in cigarettes smoked and exhaled CO was observed. Despite substantially increased nicotine concentrations (e.g., up to 3 times the approved dose) there were no significant adverse reactions. Concurrent use of NR products and cigarette smoking appears to be safe.

Long-term effects of the Eclipse cigarette substitute and the nicotine inhaler in smokers not interested in quitting.

This study investigated the long term use of Eclipse, a cigarette-like device that heats rather than burns tobacco, and the Nicorette oral inhaler, a nicotine replacement product, in a group of smokers not interested in quitting smoking. Subjects were recruited from a previous four-week controlled trial with the Eclipse and the inhaler (Fagerström, Hughes, Rasmussen, & Callas, 2000). Thirty eight subjects from the previous study were given the opportunity to continue to reduce their smoking for eight weeks and to choose Eclipse or the inhaler to aid reduction in cigarette smoking. If they did not like either of the two products they were allowed to smoke their own brand of cigarettes. A total of 39% percent chose to use the inhaler, 26% the Eclipse, and 34% neither. Number of cigarettes smoked per day decreased 86% with the Eclipse and 68% with the inhaler. Exhaled carbon monoxide increased 45% with Eclipse and decreased 47% with the inhaler. No differences were seen with craving for cigarettes between the products. Cigarette users showed stable values for cigarettes per day, exhaled carbon monoxide (CO) and nicotine/cotinine concentrations. These results replicate and extend our prior results; i.e. both Eclipse and inhaler clearly reduced smoking of traditional cigarettes and with no loss of effect over time. For Eclipse this was accompanied by maintenance of nicotine levels but increases in CO whereas for the inhaler this was accompanied by a reduction in CO intake.

A naturalistic cohort study on effectiveness, safety and usage pattern of an over-the-counter nicotine patch. Cohort study on smoking cessation.

INTRODUCTION. Nicotine replacement therapies (NRT) are effective for smoking cessation. After having received over-the-counter (OTC) status in Germany, concerns grew about effectiveness, increased risks, especially of adverse cardiovascular reactions, and inappropriate use of NRT. Thus, a pharmacy-based cohort study was launched. OBJECTIVES. To assess effectiveness, safety and appropriateness of use of an OTC nicotine patch (Nicotinell, Novartis Ltd.). Every customer who bought an OTC Nicotinell patch was eligible. All data were collected by self-administered questionnaires at weeks 2, 4, 8, 12 and 24 after inclusion. Six hundred and thirty-three customers were admitted, median duration of smoking was 19 years. Of the participants, 6% smoked up to 10 cigarettes per day, 43.6% between 11 and 20, 34.3% between 21 and 30, and 16.1% more than 30 cigarettes. Twenty-four weeks later, 351 participants replied: 28% (177 of 633) had quit smoking completely. Considering replies only the proportion of complete responders raised to 50.4%. There were no serious adverse events reported; 62.9% complied with the directions for use and did not use the patch for more than 3 months. About 45% smoked simultaneously with NRT. Pharmacy-based cohort studies are feasible. This study indicates that the nicotine patch is effective and safe in an OTC setting. There is still room to improve compliance with the directions for use.

Development and validation of a self-rating scale for positive- and negative-reinforcement smoking: The Michigan Nicotine Reinforcement Questionnaire.

Positive- and negative-reinforcement consequences of smoking were assessed using a self-report inventory. Data from 429 current smokers (348 women, 81 men) were subjected to an exploratory factor analysis, with concurrent validation of resulting scales in 288 current smokers (235 women, 53 men), controlling for sex and age. The solution with three factors--positive reinforcement, negative reinforcement, and smoking patterns--provided the clearest and most interpretable factor solution. The Michigan Nicotine Reinforcement Questionnaire (M-NRQ), which yields positive- and negative-reinforcement scales, was developed based on these results. Positive-reinforcement smoking was associated with higher scores on novelty seeking, reward dependence, alcohol dependence, and pleasurable sensations upon early smoking experimentation, and with lower scores on displeasurable sensations and nausea upon early smoking experimentation. Negative-reinforcement smoking was associated with higher scores for nicotine dependence, depression, anxiety, and harm avoidance. The M-NRQ has potential as a diagnostic tool for individualizing behavioral intervention and pharmacotherapy and also may be useful in identifying new phenotypes for genetic research on smoking.