Acute and intermediate effects of smoking cessation on erectile functioning

说明(申请人提供)：烟草使用是当今世界上最可预防的疾病和死亡原因，可导致多种疾病，包括多种癌症、心血管疾病和呼吸系统疾病。仅在美国，每五例死亡中就有一例与吸烟有关，这意味着每年与健康相关的经济损失估计为1570亿美元。据报道，性功能障碍也是长期吸烟的后遗症。大量文献表明，吸烟是导致男性勃起功能障碍的独立危险因素，长期吸烟者报告勃起功能障碍的可能性大约是不吸烟者的1.5至2倍。这项研究的主要目的是首次对戒烟对勃起障碍男性的生理和性功能主观测量的急性和中期影响进行实证研究。吸烟者(N=100)将接受4次测试；在随机吸烟时的基线、尼古丁透皮贴片治疗的第一周(21 Mg)、贴片停止后24小时和贴片停止后8周。参与者将以递减的方式使用尼古丁贴片8周(4周每天21毫克；2周每天14毫克；2周每天7毫克)。在每次就诊期间，将通过严格的心理生理技术(阴茎体积描记术测量勃起能力)和自我报告测量(性唤醒、性欲和性满足)评估性功能。性激素(睾酮)和体内尼古丁浓度水平将在每次就诊期间进行额外评估。吸烟者的性功能将与匹配的不吸烟对照组(N=30)进行比较，以确定吸烟的男性在生理、生理和性功能的主观方面是否重新获得了与不吸烟者相似的特征。本研究采用转化式研究方法，希望这些发现有可能促进针对男性吸烟预防和戒烟的计划和干预。因此，我们相信，这项研究的目的将有助于推动国家药物滥用研究所(NIDA)行为和综合治疗分会(BITB)在临床神经科学和行为研究(DCNBR)分部内的使命。

DESCRIPTION (provided by applicant): Tobacco use constitutes the single most preventable cause of disease and death in the world today and is responsible for introducing a number of diseases including many types of cancer, cardiovascular diseases, and respiratory diseases. In the United States alone one in every five deaths is smoking related, which translates to an estimated $157 billion in health-related economic losses each year. Impairment in sexual functioning has also been reported as sequelae of long-term tobacco intake. Extensive literature indicates that cigarette smoking is an independent risk factor for introducing erectile impairment in men, and that chronic smokers are approximately 1.5 to 2 times as likely as nonsmokers to report erectile dysfunction. The primary aim of the study is to provide the first empirical investigation of both the acute and intermediate effects of smoking cessation on physiological and subjective measures of sexual function in men who are experiencing erectile impairments. Smoking participants (N=100) will be tested 4 times; at baseline while smoking ad lib, during the first week of nicotine transdermal patch treatment (21 mg), 24 hours after patch cessation, and 8 weeks after patch cessation. Participants will use the nicotine patch for 8 weeks in a step-down fashion (21 mg daily for 4 weeks; 14 mg daily for 2 weeks; 7 mg daily for 2 weeks). During each visit, sexual functioning will be assessed via rigorous psycho-physiological techniques (penile plethysmography to measure erectile capacity) and by self-report measures (sexual arousal, sexual desire, and sexual satisfaction). Sex hormones (testosterone) and in vivo nicotine concentration levels will additionally be assessed during each visit. The sexual functioning of smokers will be compared to matched, nonsmoking controls (N=30) in order to ascertain whether men who smoke regain a similar profile to nonsmokers with respect to biological, physiological, and subjective aspects of sexual function. The present study adopts a translational research approach in the hope that these findings may have the potential for facilitating programs and interventions targeting the prevention and cessation of cigarette smoking in men. We therefore believe that the aims of the present study will help further the mission of the National Institute for Drug Abuse's (NIDA) Behavioral and Integrative Treatment Branch (BITB), within the Division of Clinical Neuroscience and Behavioral Research (DCNBR).