Future large randomized trials to confirm these results are needed. A review by Perkins , describes studies that demonstrate females have reduced sensitivity to nicotine reinforcement and reward. Females were more likely to quit smoking than males when assigned to either of the conditions that incorporated the VLNC cigarettes; however, males were more likely to quit smoking in the nicotine patch alone condition than females. Biomarkers of tobacco exposure measures included a alveolar carbon monoxide CO ; b urinary total nicotine equivalents TNE; Hecht, et al. Smokers in the cigarette conditions were informed that they should smoke the study cigarettes exclusively and ad libitum.
A review by Perkins , describes studies that demonstrate females have reduced sensitivity to nicotine reinforcement and reward. Participants were seen weekly for two baseline visits and eight treatment visits with additional treatment visits at weeks 10 and 12 and follow-up visits at weeks 16, 24 and Conclusion Sex of the smoker may be an important determinant for effects of VLNC cigarettes and nicotine patch. Switching to smoking very low nicotine content VLNC cigarettes from usual brand cigarettes has been shown to reduce the number of cigarettes smoked, toxicant exposure, withdrawal symptoms and dependence Benowitz, et al. The advertisements included a description of the study as a novel approach to quitting smoking by using a new tobacco product to aid in the transition of becoming smoke free. Abstract Background When switching from usual brand cigarettes, very low nicotine content VLNC cigarettes lead to a reduction in the number of cigarettes smoked, toxicant exposure, withdrawal symptoms and dependence. Statistical Analysis Demographic data and smoking history were summarized using descriptive statistics. The p-value for each post-hoc test was adjusted for multiple comparisons within each outcome using a Bonferroni correction. Subjects and Study Design Methods for this study have been previously published D. This is important as VLNC cigarettes may improve smoking cessation outcomes among females in a way that current NRTs have not been as successful. Females had higher values for all three biomarkers. In addition to examining the outcomes across the 6 study visits, analyses were conducted to focus on expected peak changes in craving and withdrawal symptoms, specifically when switching from usual brand cigarettes to the assigned products baseline to week 1 and when coming off the study products week 6 to week 7. Differences in abstinence rates were analyzed using logistic regression models, including treatment, sex, and sex by treatment interaction effects. Hatsukami, Hertsgaard, et al. At the end of the 6-week product use period, participants were asked to discontinue all product use and provided behavioral treatment for an additional 6 weeks. Furthermore, when given the opportunity to work for additional puffs on a cigarette, no differences were observed between the two yield cigarettes for females while males earned more puffs on the higher doses cigarette. Therefore, analyses were also conducted stratified by sex to explore patterns for those without statistically significant sex by treatment or sex by treatment by visit interaction effects. Smokers in the cigarette conditions were informed that they should smoke the study cigarettes exclusively and ad libitum. Note that while the sample sizes in each treatment group for the primary comparisons were 76—90, once this was additionally split by gender these numbers were reduced 32—47 participants in each treatment group. Future large randomized trials to confirm these results are needed. Hatsukami, Perkins, et al. Smokers assigned to the nicotine patch were provided instructions described in the medication insert and asked to only use the nicotine patch as the medicinal nicotine product. Participants were screened over the telephone to determine if they met the following eligibility criteria: Females, compared to males, show less differential self-administration of nicotine versus placebo when administered via nasal spray, less choice of nicotine spray over placebo, and less response to pre-treatment with nicotine especially at lower doses of nicotine. These results should be interpreted cautiously as this is a secondary analysis with a relatively small sample size for this purpose. Hatsukami, Kotlyar, et al. As in the main study, we conducted an intention-to-treat analysis.
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