Menstrual Phase Effects on Smoking Relapse

产品说明：（申请人提供）：尽管越来越多的知识和公众意识到吸烟与肺癌和冠心病等不良健康后果之间的联系，但近24%的美国成年人吸烟，女性（22%）和男性（26%）的吸烟率自1990年以来一直保持相对稳定。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遭受更大的健康风险，她们每年因吸烟而死亡的人数正迅速接近男性。戒烟策略已经取得了进展，但在试图戒烟的人中，复发吸烟仍然很常见，特别是在女性中，他们似乎比男性复发更快，更彻底，对他们来说，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不太有效。 这项研究的长期目标是通过制定循证戒烟策略来降低女性吸烟率-这些策略专门针对女性对尼古丁的独特生理反应，并解决戒烟的具体障碍（例如，戒断、以抑郁症状为重点的负面影响和体重增加），其中许多在临床研究中已被证明具有性别特异性影响。这种竞争性更新的具体目的是（1）确定吸烟复吸率如何受到开始戒烟的月经周期阶段的影响，以及（2）确定戒烟期间阶段对潜在复吸相关因素的影响：戒断和经前症状，体重增加和负面影响，特别关注抑郁症状。最终的次要目的是确定研究参与者在重复戒烟尝试后最有可能复发的周期阶段。拟议的3年研究是一项女性戒烟的随机临床治疗试验[不受对照]（N = 200）。作为门诊患者招募的参与者将被随机分为两组，戒烟日期定时在特定月经周期阶段（卵泡期或黄体晚期）发生。通过生化测试、参与者自我报告和书面调查工具，将在26周的治疗期间收集并分析以下结果的数据：吸烟状态（复发/非复发）、戒断和经前抑郁症、关注抑郁症状的负面影响以及体重、心率和血压的生理指标。这项研究的基本原理是，一旦了解了月经周期阶段对这些结果的影响，其结果可用于为女性吸烟者提供最佳治疗干预措施的发展，这些干预措施可解释生理影响，从而最大限度地减少开始和维持戒烟的障碍。此外，这项研究有望为未来研究尼古丁反应、戒断和其他戒烟相关变量的性别差异提供一个框架。

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.