RESUMO
INTRODUCTION: The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC). METHODS: A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation. RESULTS: The RNC (n = 122) versus UNC (n = 123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99 to 5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference -137 ng/mL; 95% CI -172, -102). The RNC group smoked fewer CPD (-4.1; 95% CI -6.44, -1.75) and had lower carbon monoxide levels (-4.0 ppm; 95% CI -7.7, -0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine = 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N = 6/22, 27%). CONCLUSIONS: This study supports a VLNC standard in cigarettes. IMPLICATIONS: Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers successfully transitioned to very low nicotine content cigarettes exclusively and substantially reduced their exposure to nicotine.
Assuntos
Abandono do Hábito de Fumar , Produtos do Tabaco , Tabagismo , Adulto , Feminino , Humanos , Masculino , Nicotina , Fumantes , Classe SocialRESUMO
INTRODUCTION: Spectrum research cigarettes have been developed with varying nicotine content for use in studies evaluating the effects of a regulatory policy reducing the permissible nicotine content in cigarettes. This study aimed to characterize the nicotine pharmacokinetic profile of Spectrum cigarettes. METHODS: Twelve daily smokers attended four sessions and had blood nicotine, exhaled carbon monoxide, and subjective effects measured before and after smoking either a single cigarette of their preferred brand or high (10.9 mg/cigarette), medium (3.2 mg/cigarette), or low (0.2 mg/cigarette) nicotine content Spectrum research cigarettes, in a double-blind design with order counterbalanced. RESULTS: The boost in blood nicotine concentration was dose-dependent, with a boost of 0.3, 3.9, and 17.3 ng/mL for low-, medium-, and high-nicotine content Spectrum cigarettes. The high dose Spectrum had a similar nicotine boost to the "preferred brand" cigarettes (19 ng/mL). Subjects took longer puffs on the low nicotine cigarettes, but smoked these cigarettes faster than other cigarette types. High nicotine Spectrum cigarettes reduced the urge to smoke more than other cigarette types. CONCLUSIONS: This study shows that Spectrum research cigarettes produce blood nicotine absorption in a dose-dependent manner, and therefore, are appropriate for use in studies of nicotine reduction in cigarettes. IMPLICATIONS: This is the first study to determine the pharmacokinetic profile of Spectrum reduced nicotine content research cigarettes following an overnight abstinence. These data could provide evidence to regulatory agencies about the effects of reduced nicotine cigarettes when considering regulations on tobacco reduction.
Assuntos
Fumar Cigarros/sangue , Nicotina/administração & dosagem , Nicotina/sangue , Abandono do Hábito de Fumar/métodos , Produtos do Tabaco , Adolescente , Adulto , Monóxido de Carbono/análise , Fumar Cigarros/psicologia , Fumar Cigarros/tendências , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Abandono do Hábito de Fumar/psicologia , Adulto JovemRESUMO
INTRODUCTION: About half of smokers relight their cigarette, a habit that is a risk factor for chronic bronchitis and possibly lung cancer. Little is known about the characteristics of smokers who relight and their dependence on nicotine. It is unknown whether relighting affects exposure to tobacco smoke constituents. This study examined the characteristics of relighters of usual brand cigarettes and whether relighting affects exposure to selected tobacco smoke constituents. METHODS: We explored relighting status and frequency, using baseline data from 248 adult smokers participating in studies of reduced nicotine cigarettes in relation to demographic and cigarette characteristics, smoking behaviors, nicotine dependence, biomarkers of exposure (exhaled carbon monoxide, blood cotinine), and biomarkers of oxidative stress (ratio of oxidized/reduced glutathione). RESULTS: 69.4% (n = 172) of subjects reported relighting, and they relit an average of five cigarettes out of 20. Both relighters and non-relighters smoked a mean of 20 cigarettes per day (p = .6). Relighting was significantly associated with higher nicotine dependence, use of longer rod cigarettes, older age, lower income, and unemployment. There were no significant associations between relighting and blood cotinine, exhaled carbon monoxide or measures of oxidized/reduced blood glutathione. CONCLUSIONS: The majority of subjects were relighters, who had higher levels of nicotine dependence than non-relighters. Relighters had similar levels of plasma cotinine and exhaled carbon monoxide to non-relighters. IMPLICATIONS: No study has compared the cigarette characteristics and biomarkers of exposure of adult cigarette smokers who relight with those who do not. Relighting behavior was common in our sample and was associated with low income, not currently working, higher nicotine dependence, cigarette rod length, daily cigarette use years, and a lifetime history of depressed mood.
Assuntos
Fumar Cigarros/psicologia , Fumantes/psicologia , Fumar/psicologia , Produtos do Tabaco/análise , Poluição por Fumaça de Tabaco/análise , Tabagismo/psicologia , Adulto , Idoso , Biomarcadores/análise , Fumar Cigarros/efeitos adversos , Fumar Cigarros/epidemiologia , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nicotina/efeitos adversos , Nicotina/análise , Fatores de Risco , Fumar/efeitos adversos , Fumar/epidemiologia , Abandono do Hábito de Fumar/psicologia , Produtos do Tabaco/efeitos adversos , Poluição por Fumaça de Tabaco/efeitos adversos , Tabagismo/diagnóstico , Tabagismo/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Price affects the demand for cigarettes, indicating that smokers, perhaps especially lower income smokers, may choose low nicotine cigarettes (LNC) if they were commercially available and cost less than fully nicotinized conventional cigarettes. The present study tests the hypothesis that smokers will prefer purchasing LNCs at a lower price point than conventional cigarettes given a fixed budget. METHOD: A laboratory-based, within-subject, 3 (nicotine level) × 3 (price) factorial design provided smokers opportunities to purchase standard (0.7 per mg tobacco), moderately reduced (0.3 mg), and very low-nicotine (0.03 mg). Spectrum research cigarettes according to an escalating price structure (low-nicotine costing the least, high-nicotine costing the most) given a fixed, laboratory-provided "income." Participants were 20 overnight-abstinent smokers who previously smoked and rated each of the three cigarettes. RESULTS: Overall, smokers rated LNCs as less satisfying compared with standard nicotine cigarettes (SNC), t(18) = -5.40, p < .001. In the free-choice session, subjects were more likely to choose LNC that cost less compared with SNC that cost more, even after an 8-hour abstinence period, F(2, 19) = 4.32, p = .03. Those selecting LNC or moderate nicotine cigarettes after abstinence smoked more cigarettes per day, t(17) = 2.40, p = .03 and had higher dependence scores on the HONC, t(18) = 2.21, p = .04 that those selecting SNC. CONCLUSION: The results indicate that smokers' response to price points when purchasing cigarettes may extend to LNC if these were commercially available. Differential cigarette prices based on nicotine content may result in voluntary selection of less addicting products. IMPLICATIONS: The Food and Drug Administration has proposed a rule that would reduce nicotine content in commercially available cigarettes. However, it is not known how smokers may respond in an environment where products of differing nicotine content and of differing prices are available. This study demonstrates that price may be an important factor that could lead smokers to select reduced nicotine products voluntarily, even if those products are rated as inferior or less satisfying.
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Fumar Cigarros/economia , Fumar Cigarros/psicologia , Comércio/economia , Nicotina/administração & dosagem , Nicotina/economia , Produtos do Tabaco/economia , Adulto , Fumar Cigarros/tendências , Comércio/tendências , Feminino , Humanos , Masculino , Fumantes/psicologia , Estados Unidos , United States Food and Drug Administration , Adulto JovemRESUMO
Introduction: Little cigars and filtered cigars are currently growing in popularity due to their low cost and wide variety of flavors while retaining an appearance similar to cigarettes. Given the health consequences associated with cigarette use, it is important to understand the potential harm associated with these similar products. This includes the potential harm associated with carbonyls (eg, acetaldehyde, acrolein, formaldehyde, etc.), an important class of toxicants and carcinogens in tobacco smoke. Our objective was to determine the carbonyl levels in mainstream smoke from little and filtered cigars compared to cigarettes. Methods: We examined two brands each of little cigars and filtered cigars, as well as two research cigarettes for carbonyl delivery using the International Organization of Standards (ISO) and the Health Canada Intense (HCI) machine-smoking protocols. Results: On a per puff basis, the levels of five of the seven carbonyls were higher from little cigars than filtered cigars and cigarettes (ISO: 56-116%; HCI: 39-85%; p < .05). On a per unit basis, most carbonyl levels were higher from both cigar types than cigarettes using the ISO method (ISO: 51-313%; p < .05) whereas only filtered cigars were higher using the HCI method (HCI: 53-99%; p < .05). Conclusion: These findings suggest that cigar smokers can be exposed to higher levels of carbonyls per cigar than cigarette smokers per cigarette. Implications: These data will increase our understanding of the relative harm from carbonyl exposure from little and filtered cigars both for cigar-only smokers and the cumulative harm among the growing population of cigarette-cigar multi-product smokers.
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Aldeídos/análise , Monóxido de Carbono/análise , Fumaça/análise , Produtos do Tabaco/análise , Aldeídos/química , Cromatografia Líquida de Alta Pressão , Humanos , Espectrofotometria UltravioletaRESUMO
Introduction: Although the popularity of small cigar brands that resemble cigarettes, including both little cigars (LC) and filtered cigars (FC), has been on the rise, little is known about the delivery of nicotine from these products. Our objective was to determine the nicotine yields of small cigars in comparison to cigarettes. Methods: Nicotine yields from LC, FC, and 3R4F and 1R6F research cigarettes were determined from mainstream smoke generated on a smoking machine under the International Organization of Standardization (ISO) and Canadian Intense (CI) methods. Market characteristics (price and package label) and physical features (filter ventilation, product weight and filter weight, product length, and diameter) were also determined for eight brands of small cigars. Results: Nicotine yields in small cigars averaged 1.24 and 3.49 mg/unit on ISO and CI regimens, respectively, compared with 0.73 and 2.35 mg/unit, respectively, for the research cigarettes. Nicotine yields per puff were similar between small cigars and cigarettes. We also found that FC did not differ from LC in nicotine yields. FC and LC differ from each other in many physical design features (unit weight, filter weight, and filter length), but are similar in others (unit length, diameter, and filter ventilation). Conclusions: Nicotine delivery from small cigars is similar to or greater than that from cigarettes. Thus, for future research and regulatory purposes, standard definitions need to be developed for small cigars, and FC and LC should be evaluated as separate entities. Implications: Small cigars are similar to cigarettes in their design and use. Although nicotine yields per puff were similar between products, small cigars delivered substantially higher amounts of nicotine per unit than cigarettes. These findings support the growing body of evidence to justify regulating all small cigars, including LC and FC in a similar fashion as cigarettes.