Progesterone Augmentation for Smoking Cessation in Women

增加黄体酮有助于女性戒烟

• 批准号: 8957427
• 负责人: Mehmet Sofuoglu
• 金额: $ 21.73万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-17 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8957427
• 关键词: Abstinence; Amenorrhea; Attenuated; Behavior Therapy; Bupropion; Cause of Death; Central Nervous System Diseases; Cessation of life; Cigarette; Clinical Practice Guideline; Clinical Research; Clinical Trials; Cocaine Dependence; Colon Carcinoma; Controlled Clinical Trials; Counseling; Data; Developed Countries; Dose; Double-Blind Method; Effectiveness; Endometrial Hyperplasia; Epilepsy; Estradiol; Estrogens; Female; Gonadal Hormones; Hormonal; Hormones; Hour; Human; Lead; Luteal Phase; Malignant neoplasm of lung; Menstrual cycle; Minnesota; Nicotine; Nicotine Dependence; Nicotine Withdrawal; Outcome Measure; Participant; Pharmaceutical Preparations; Pharmacotherapy; Placebo Control; Placebos; Plasma; Progesterone; Public Health; Questionnaires; Randomized; Randomized Clinical Trials; Relapse; Rewards; Risk; Role; Safety; Salivary; Signal Transduction; Smoke; Smoker; Smoking; Synthetic Progestogens; Testing; Therapeutic; Time; Tobacco Dependence; Translating; Traumatic Brain Injury; Treatment Effectiveness; Uterine hemorrhage; Withdrawal Symptom; Withholding Treatment; Woman; Work; assisted reproduction; cigarette smoking; craving; effective therapy; follow-up; improved; killings; malignant breast neoplasm; men; nicotine patch; nicotine replacement; novel; premature; proliferative phase Menstrual cycle; public health relevance; response; safety testing; smoking cessation; smoking prevalence; success; varenicline

 DESCRIPTION (provided by applicant): Nicotine addiction continues to be the main preventable cause of death in developed countries, with an estimated 435,000 premature deaths in the U.S. Despite the availability of effective pharmacotherapies, 70 to 90% of smokers who attempt to quit resume smoking within a year of treatment. Women may have greater difficulty achieving and sustaining abstinence from smoking, as the ratio of former smokers to ever smokers (quit ratio) is lower in women (55.2%) than in men (59.2%). Women, compared to men, are more vulnerable to the complications of smoking, most notably lung cancer. In the US, lung cancer kills more women than breast and colon cancer combined. These findings support the need for effective treatments tailored for female smokers. One such approach may include use of progesterone to augment currently available smoking cessation treatments. Data from clinical studies suggest that in women with regular menstrual cycles, those who try to quit smoking when endogenous plasma progesterone levels are high, have a lower risk of relapse to smoking than those who try to quit when progesterone levels are low. Work from our group points to a potential therapeutic role for progesterone, in that progesterone attenuates both craving for cigarettes and the pleasurable effects of smoking among recently abstinent female smokers. Taken together, these findings led us to hypothesize that progesterone may augment the efficacy of smoking cessation treatments in regularly cycling women. This proof-of-concept study will test the safety, tolerability, and effectiveness of progesterone treatment, compared to placebo, in combination with transdermal nicotine patch (TNP) for smoking cessation in regularly cycling women. We propose an 8-week, pilot, clinical trial in which 50 smokers will be randomized to progesterone (200 mg twice daily) or placebo. All participants will also receive TNP and behavioral treatment for smoking cessation during study participation. Smokers will attempt to quit smoking one week after initiation of progesterone and TNP treatment. The main outcome measures will be the prolonged and 7-day point prevalence of smoking abstinence at the end of treatment and at 1- and 3-month follow-up time points. Progesterone, in contrast to the more commonly used synthetic progestins, is a natural hormone with excellent safety profile and its use as a novel smoking cessation medication in women is highly feasible.

 描述（由适用提供）：尼古丁成瘾仍然是发达国家的主要可预防原因，尽管有效的药物治疗措施有效，但估计在美国有435,000例早期死亡，但仍有70％至90％的吸烟者试图在一年的治疗中戒烟。妇女可能难以实现吸烟和戒酒，因为以前吸烟者与烟民的比率（戒烟比率）低于男性（55.2％）（59.2％）。与男性相比，女性更容易受吸烟的并发症，最著名的是肺癌。在美国，肺癌杀死的女性比乳腺癌和结肠癌的总和更多。这些发现支持了为女性吸烟者量身定制的有效治疗的需求。一种这样的方法可能包括使用孕酮来增加目前可用的戒烟治疗。来自临床研究的数据表明，在常规月经周期的女性中，在内源性血浆孕激素水平很高时试图戒烟的患者比在孕酮水平低时试图戒烟的患者降低了吸烟的风险。我们小组的工作指出了孕酮的潜在治疗作用，因为孕酮既减弱渴望香烟的渴望，又减弱了最近戒烟的女性吸烟者的愉悦作用。顺便说一句，这些发现使我们假设孕激素可能会增强定期骑自行车妇女中戒烟治疗的有效性。与安慰剂相比，这项概念验证研究将测试孕激素治疗的安全性，耐受性和有效性，并结合经皮尼古丁贴片（TNP）在定期骑自行车的妇女中戒烟。我们提出了为期8周的试验，临床试验，其中50名吸烟者将被随机分为孕酮（每天两次）或安慰剂。所有参与者还将在研究期间接受TNP和行为治疗，以戒烟。吸烟者将在开始孕酮和TNP治疗后一周戒烟。主要的结果指标将是在治疗结束时以及1个月和3个月的随访时间点戒烟的延长和7天点的流行率。与更常用的合成孕激素相比，孕酮是一种天然的赛酮，具有出色的安全性，它用作女性的新型戒烟药物是非常可行的。