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1.  Dependence on Tobacco and Nicotine Products: A Case for Product-Specific Assessment 
Nicotine & Tobacco Research  2012;14(11):1382-1390.
The International Classification of Diseases and the Diagnostic and Statistical Manual for diagnosing tobacco/nicotine dependence emphasize the dependence-producing drug nicotine. These diagnostic tools have been challenged on grounds of poor predictive validity, and they do not differentiate across various forms of nicotine-containing products. In fact, nicotine-containing products (e.g., tobacco cigarettes, smokeless tobacco [ST], waterpipe, electronic cigarettes [ECIGs], and nicotine replacement [NR] products) have very different characteristics both in terms of sensory and behavioral involvement and also in pharmacokinetic and pharmacodynamic effects. For example, a cigarette and a nicotine patch are very different on almost every one of these dimensions. When ability to stop using a nicotine/tobacco product is used as a criterion for dependence, success rates vary considerably across products: Tobacco cigarette cessation is more difficult than ST cessation that in turn is more difficult than NR product cessation. Based on these results, we hypothesize that there is a continuum of dependence as much as there is a continuum of harm, with tobacco cigarettes and NR products on opposite ends of both continua and other products (waterpipe and ECIGs) somewhere in between. In order to capture more precisely the dependence produced by both nicotine and its administration forms, product-specific instruments may be required. The pros and cons of this approach are discussed.
doi:10.1093/ntr/nts007
PMCID: PMC3611984  PMID: 22459798
2.  Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial  
Objective To assess the efficacy and safety of varenicline (a licensed cigarette smoking cessation aid) in helping users of smokeless tobacco to quit.
Design Double blind, placebo controlled, parallel group, multicentre, randomised controlled trial.
Setting Medical clinics (mostly primary care) in Norway and Sweden.
Participants Men and women aged ≥18 who used smokeless tobacco at least eight times a day, with no abstinence period over three months within one year before screening, who wanted to quit all tobacco use. Participants were excluded if they used any other form of tobacco (except smokeless tobacco) or medication to stop smoking within three months of screening or had any pre-existing medical or psychiatric condition.
Interventions Varenicline 1 mg twice daily (titrated during the first week) or placebo for 12 weeks, with 14 weeks’ follow-up after treatment.
Main outcome measures The primary end point was the four week continuous abstinence rate at the end of treatment (weeks 9-12) confirmed with cotinine concentration. A secondary end point was continuous abstinence rate for weeks 9-26. Safety and tolerability were also evaluated.
Results 431 participants (213 varenicline; 218 placebo) were randomised and received at least one dose of study drug. Participants’ demographics and baseline use of smokeless tobacco were similar (89% (189) and 90% (196), respectively, were men; mean age in both groups was 43.9; participants used smokeless tobacco products about 15 times a day, and about 80% first used smokeless tobacco within 30 minutes after awakening). Continuous abstinence rate at week 9-12 was higher in the varenicline group than the placebo group (59% (125) v 39% (85); relative risk 1.60, 95% confidence interval 1.32 to 1.87, P<0.001; risk difference 20%; number needed to treat 5). The advantage of varenicline over placebo persisted through 14 weeks of follow-up (continuous abstinence rate at week 9-26 was 45% (95) v 34% (73); relative risk 1.42, 1.08 to 1.79, P=0.012; risk difference 11%; number needed to treat 9). The most common adverse events in the varenicline group compared with the placebo group were nausea (35% (74) v 6% (14)), fatigue (10% (22) v 7% (15)), headache (10% (22) v 9% (20)), and sleep disorder (10% (22) v 7% (15)). Few adverse events led to discontinuation of treatment (9% (19) and 4% (9), respectively), and serious adverse events occurred in two (1%) and three (1%) participants, respectively.
Conclusion Varenicline can help people to give up smokeless tobacco and has an acceptable safety profile. The response rate in the placebo group in this study was high, suggesting a population less resistant to treatment than smokers.
Trial Registration NCT00717093.
doi:10.1136/bmj.c6549
PMCID: PMC2997603  PMID: 21134997
3.  Smoking Cessation: It Is Never Too Late 
Diabetes Care  2009;32(Suppl 2):S423-S425.
doi:10.2337/dc09-S352
PMCID: PMC2811467  PMID: 19875593
4.  A comparison of the Fagerström Test for Nicotine Dependence and smoking prevalence across countries 
Addiction (Abingdon, England)  2008;103(5):841-845.
Aims
To examine the correlation between the Fagerström Test for Nicotine Dependence (FTND) score and smoking prevalence across countries.
Design
Cross-sectional study.
Setting
Fifteen studies from 13 countries with FTND score data.
Participants
Samples of smokers were identified through systematic literature searches, web queries and colleagues. Smokers were considered representative of their country's smoking population if they were drawn from population-based sources, were not seeking smoking cessation treatment and did not have significant comorbidities. Smoking prevalence data were derived from the study itself or the country's population rate of daily smoking for the study year.
Measurements
A Pearson correlation coefficient was used to examine the direction and magnitude of the correlation between FTND score and smoking prevalence across countries.
Findings
FTND scores ranged from 2.8 to 4.6. Smokers in Germany and Norway had the lowest FTND scores, while smokers in Sweden and the United States had the highest FTND scores. The prevalence of daily smoking in these countries was very different: 37% and 30% in Germany and Norway, 19% and 16% in the United States and Sweden, respectively. An inverse correlation towards higher FTND scores in countries with lower smoking prevalence was found (r = -0.73, P = 0.001). Current smokers had higher FTND scores than former smokers.
Conclusions
The significant inverse correlation between FTND score and smoking prevalence across countries and higher FTND score among current smokers supports the idea that remaining smokers may be hardening. Less dependent smokers may quit more easily and remaining dependent smokers may need more intensive treatment.
doi:10.1111/j.1360-0443.2008.02190.x
PMCID: PMC2914535  PMID: 18412764
Correlation; country; FTND score; hardening; nicotine dependence; smoking prevalence
5.  Varenicline in the treatment of tobacco dependence 
Varenicline, a partial agonist of α4β2 nicotinic acetylcholine receptors, is the most recently approved drug for smoking cessation. This paper reviews the outcomes of Phase 2 and Phase 3 clinical trials that assess the efficacy of varenicline in comparison to placebo and other smoking cessation pharmacotherapies, ie, sustained-release bupropion (bupropion SR) and nicotine transdermal patch. Varenicline has higher abstinence rates than placebo and the alternative active treatments at the end of standard regimen treatment periods. Significantly higher abstinence rates were also found with varenicline in comparison to both placebo and bupropion SR at the end of a 40-week non-treatment follow-up period. Varenicline typically tripled the abstinence rates compared with placebo. In addition, varenicline reduced craving and withdrawal symptoms as well as some of the positive experiences associated with smoking to a greater extent than placebo, bupropion SR, and nicotine replacement therapy (NRT). These findings are consistent with the proposed agonist/antagonist effects of varenicline. Preliminary studies assessing individual variables such as smoking dependency level and smoking reinforcement types provide justification to examine further the effects of varenicline according to these individual factors. Outcomes from such research could improve our understanding of varenicline’s mechanism of action and could ultimately help clinicians to develop individualized smoking cessation programs. Also, given varenicline’s ability to reduce the reward from smoking, it might be helpful to use it before cessation to motivate or prepare smokers for a quit attempt.
PMCID: PMC2518383  PMID: 18728741
varenicline; smoking cessation; nicotinic partial agonist
6.  Introducing oral tobacco for tobacco harm reduction: what are the main obstacles? 
With the number of smokers worldwide currently on the rise, the regular failure of smokers to give up their tobacco addiction, the direct role of smoke (and, to a much lesser extent, nicotine) in most tobacco-related diseases, and the availability of less toxic (but still addictive) oral tobacco products, the use of oral tobacco in lieu of smoking for tobacco harm reduction (HR) merits assessment.
Instead of focusing on the activity itself, HR focuses on the risks related to the activity. Currently, tobacco HR is controversial, generally not discussed, and consequently, poorly evaluated.
In this paper, we try to pinpoint some of the main reasons for this lack of interest or reluctance to carry out or fund this type of research. In this paper we deal with the following issues: the status of nicotine in society, the reluctance of the mainstream anti-tobacco lobby toward the HR approach, the absence of smokers from the debate, the lack of information disseminated to the general population and politicians, the need to protect young people, the role of physicians, the future of HR research, and the role of tobacco companies.
doi:10.1186/1477-7517-4-17
PMCID: PMC2169217  PMID: 17988383

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