Menstrual Phase Effects on Smoking Relapse

描述：（由申请人提供）：尽管公众对吸烟与不良健康结果（如肺癌和冠心病）之间的联系的认识和意识不断提高，但近24%的美国成年人吸烟，自1990年以来，女性（22%）和男性（26%）的吸烟率保持相对稳定。妇女的健康尤其令人关切，因为研究表明，女性吸烟者可能比男性面临更大的健康风险，她们每年与烟草有关的死亡人数正在迅速接近男性。在戒烟策略方面已经取得了进展，但在试图戒烟的人群中，复吸仍然很常见，尤其是那些比男性更快、更彻底复吸的女性，对她们来说，尼古丁贴片和口香糖在减少对香烟的渴望和其他戒断症状方面可能效果较差。

DESCRIPTION: (provided by applicant): Despite increasing knowledge and public awareness about the link between cigarette smoking and adverse health outcomes such as lung cancer and coronary heart disease, nearly 24% of U.S. adults smoke cigarettes, and the smoking prevalence rates in women (22%) and men (26%) have remained relatively constant since 1990. Women's health is of particular concern, since studies show that female smokers may suffer greater health risks than men, and their annual tobacco-related deaths are rapidly approaching those of men. Advances have been made in smoking cessation strategies, but relapse to smoking is still common in people attempting to quit, especially in women who appear to relapse faster and more completely than men, and for whom nicotine patches and gum may be less effective in reducing craving for cigarettes and other withdrawal symptoms. The long-term goal of this research is to decrease smoking prevalence among women through the development of evidence-based smoking cessation strategies - strategies specifically tailored to women's unique physiological responses to nicotine and which address specific barriers to cessation (e.g., withdrawal, negative affect focusing on depressive symptoms, and weight gain), many of which in clinical studies have been shown to have gender-specific influences. The specific aims of this competing renewal are (1) to determine how smoking relapse rates are influenced by the menstrual cycle phase in which smoking cessation is initiated, and (2) to determine the impact of phase during smoking abstinence on potential relapse-related factors: withdrawal and premenstrual symptoms, weight gain, and negative affect, focusing specifically on depressive symptoms. A final, secondary aim will be to identify the cycle phase during which study participants are most likely to relapse following a repeat quit attempt. The proposed 3-year study is a randomized clinical treatment trial [it isn't controlled] of smoking cessation in women (N = 200). Participants enrolled as outpatients will be randomized into two groups for smoking quit dates timed to occur during a particular menstrual cycle phase (follicular or late luteal). Through biochemical testing, participant self-report, and written survey instruments, data will be collected and analyzed over the 26-week treatment period on the following outcomes: smoking status (relapsed/non-relapsed), withdrawal and premenstrual symptomatology, negative affect focusing on depressive symptoms, and the physiological measures of weight, heart rate, and blood pressure. The rationale underlying this research is that once the effects of menstrual cycle phase on these outcomes are understood, the results can be used to inform the development of optimal treatment interventions for women smokers which account for physiologic influences and thereby minimize barriers to starting and maintaining smoking abstinence. Furthermore, this study is expected to provide a framework for future research investigating gender differences in nicotine response, withdrawal, and other cessation-related variables.