Nicotine and Carcinogen Exposure with Smoking of Progressively Reduced Nicotine Content Cigarette (original) (raw)
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Addiction (Abingdon, England), 2015
A broadly mandated reduction of the nicotine content (RNC) of cigarettes has been proposed in the United States to reduce the addictiveness of cigarettes, to prevent new smokers from becoming addicted and to facilitate quitting in established smokers. The primary aim of this study was to determine whether following 7 months of smoking very low nicotine content cigarettes (VLNC), and then returning to their own cigarettes, smokers would demonstrate persistently reduced nicotine intake compared with baseline or quit smoking. In a community-based clinic 135 smokers not interested in quitting were randomized to one of two groups. A research group smoked their usual brand of cigarettes, followed by five types of research cigarettes with progressively lower nicotine content, each for 1 month, followed by 6 months at the lowest nicotine level (0.5 mg/cigarette) (53 subjects) and then 12 months with no intervention (30 subjects completed). A control group smoked their usual brand for the sa...
Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation
Addiction, 2010
To examine the effects of reduced nicotine cigarettes on smoking behavior, toxicant exposure, dependence and abstinence. Design Randomized, parallel arm, semi-blinded study. Setting University of Minnesota Tobacco Use Research Center. Interventions Six weeks of: (i) 0.05 mg nicotine yield cigarettes; (ii) 0.3 mg nicotine yield cigarettes; or (iii) 4 mg nicotine lozenge; 6 weeks of follow-up. Measurements Compensatory smoking behavior, biomarkers of exposure, tobacco dependence, tobacco withdrawal and abstinence rate. Findings Unlike the 0.3 mg cigarettes, 0.05 mg cigarettes were not associated with compensatory smoking behaviors. Furthermore, the 0.05 mg cigarettes and nicotine lozenge were associated with reduced carcinogen exposure, nicotine dependence and product withdrawal scores. The 0.05 mg cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the nicotine lozenge. The 0.05 mg cigarette led to a significantly higher rate of cessation than the 0.3 mg cigarette and a similar rate as nicotine lozenge. Conclusion The 0.05 mg nicotine yield cigarettes may be a tobacco product that can facilitate cessation; however, future research is clearly needed to support these preliminary findings.
Nicotine reduction revisited: science and future directions
Tobacco Control, 2010
Regulation of nicotine levels in cigarettes and other tobacco products is now possible with the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009 giving the U.S. Food and Drug Administration authority to regulate tobacco products, and with Articles 9-11 of the World Health Organization Framework Convention on Tobacco Control.[1-2] Both regulatory approaches allow establishing product standards for tobacco constituents, including nicotine. The FSPTCA does not allow nicotine levels to be decreased to zero, although FDA has the authority to reduce nicotine yields to very low, presumably non-addicting levels. The proposal to reduce levels of nicotine to a level that is non-addicting was originally suggested in 1994.[3] Reduction of nicotine in tobacco products could potentially have a profound impact on reducing tobacco-related morbidity and mortality. To examine this issue, two meetings were convened in the United States with non-tobacco-industry scientists of varied disciplines, tobacco control policy-makers and representatives of government agencies. This article provides an overview of the current science in the area of reduced nicotine content cigarettes and key conclusions and
Compensatory smoking from gradual and immediate reduction in cigarette nicotine content
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2015
Reducing the addictiveness of cigarettes by reducing their nicotine content can potentially have a profound impact on public health. Two different approaches to nicotine reduction have been proposed: gradual and immediate. To determine if either of these approaches results in significant compensatory smoking behavior, which might lead to safety concerns, we performed a secondary analysis of data from studies that have utilized these two approaches. The number of cigarettes smoked per day, carbon monoxide exposure, and cotinine levels in plasma or urine were assessed while participants smoked reduced nicotine content cigarettes and compared with when they smoked their usual brand cigarettes. The results showed that in general, these two approaches led to minimal compensatory smoking and reduced levels of cotinine over the course of the experimental period, suggesting that neither of these approaches poses a major safety concern.
JAMA, 2018
The optimal temporal approach for reducing nicotine to minimally or nonaddictive levels in all cigarettes sold in the United States has not been determined. To determine the effects of immediate vs gradual reduction in nicotine content to very low levels and as compared with usual nicotine level cigarettes on biomarkers of toxicant exposure. A double-blind, randomized, parallel-design study with 2 weeks of baseline smoking and 20 weeks of intervention was conducted at 10 US sites. A volunteer sample of daily smokers with no intention to quit within 30 days was recruited between July 2014 and September 2016, with the last follow-up completed in March 2017. (1) Immediate reduction to 0.4 mg of nicotine per gram of tobacco cigarettes; (2) gradual reduction from 15.5 mg to 0.4 mg of nicotine per gram of tobacco cigarettes with 5 monthly dose changes; or (3) maintenance on 15.5 mg of nicotine per gram of tobacco cigarettes. Between-group differences in 3 co-primary biomarkers of smoke to...
Nicotine Reduction in Cigarettes: Literature Review and Gap Analysis
Nicotine & Tobacco Research, 2019
Background The US Food and Drug Administration (FDA) is considering reducing nicotine levels in cigarettes to “minimally or non-addictive levels.” However, important research gaps remain, and the FDA must determine when the available research is sufficient to support moving forward. Methods The authors conducted a systematic review of research articles in PubMed relating to nicotine reduction. Building on a review of risk assessment best practices, the authors also developed a risk assessment framework for tobacco regulation and used it to guide a gap analysis of nicotine reduction research. Results The final sample consisted of 78 articles. The majority examined either nicotine dependence on very low nicotine cigarettes (VLNCs) or markers of potential health effects of using VLNCs. One-third of the identified articles reported results from four large randomized controlled trials (RCTs). While these studies report promising results and suggest that a nicotine reduction rule would be...
Tobacco, nicotine and harm reduction
Drug and Alcohol Review, 2011
Issues. Tobacco smoking, sustained by nicotine dependence, is a chronic relapsing disorder, which in many cases results in lifelong cigarette use and consequent death of one out of two lifelong smokers from a disease caused by their smoking. Most toxicity due to cigarette smoking is related to the burning process. Approach. Models of harm reduction applied to tobacco suggest that use of non-combustible, less toxic, nicotine-containing products as a substitute for cigarette smoking would reduce the death toll arising from tobacco use. Available options include medicinal nicotine and smokeless tobacco products. Key Findings. The potential role of nicotine replacement therapy (NRT) products in a harm reduction strategy is currently severely restricted by strict regulations on dose, safety and potential addictiveness. As a result, NRT products are designed to provide much less nicotine, and deliver it to the brain more slowly, than cigarettes, which are widely accessible and poorly regulated. Smokeless tobacco (snus) has proved to be an acceptable reduced hazard alternative to smoking in Sweden, but supply of snus is illegal elsewhere in the European Union. Implications. To increase accessibility and reach more smokers, barriers to the use of NRT use need to be removed and more effective NRTs need urgently to be developed. Smokeless tobacco could also play an important role in harm reduction, but current European Union regulations and concerns over exploitation by tobacco companies currently preclude wider use. Conclusion. To improve public health there is an urgent need for an appropriate regulatory framework and regulatory authority at the European level, controlling both tobacco and nicotine products to ensure that the least harmful products are the most accessible.
Reduced Nicotine Content Cigarettes and Nicotine Patch
Cancer Epidemiology Biomarkers & Prevention, 2013
Background: Reduced nicotine content (RNC) cigarettes have led to smoking fewer cigarettes, withdrawal relief, and facilitation of cessation. The aim of this study is to examine the effects RNC cigarettes with and without nicotine patch and patch alone on smoking behavior, toxicant exposure, withdrawal discomfort, and as an exploratory analysis, on long-term abstinence. Methods: This study involved a randomized, parallel arm design and six weeks of: (i) 0.05-0.09 mg nicotine yield cigarettes (N ¼ 79); (ii) 21 mg nicotine patch (N ¼ 80), or (iii) 0.05-0.09 nicotine yield cigarettes with 21 mg nicotine patch (N ¼ 76); all groups received six weeks of additional behavioral treatment with follow-ups up to six months. Results: Combination approach led to lower rates of smoking assigned cigarettes and hence lower carbon monoxide levels than RNC cigarettes alone. In addition, the combination approach was associated with less withdrawal severity when switching from usual brand to assigned product, and less smoking of usual brand cigarettes during treatment, but not after treatment compared with the other approaches. Conclusion: Combining very low nicotine content cigarettes with nicotine patch may improve the acute effects resulting from switching to either of these products alone. Impact: These findings may have implications for smoking cessation treatment or a policy measure to reduce nicotine content in cigarettes. Cancer Epidemiol Biomarkers Prev; 22(6); 1015-24. Ó2013 AACR.