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（由申请人提供）：尼古丁成瘾仍然是发达国家可预防的主要死亡原因，据估计，美国有 435,000 人过早死亡。尽管有有效的药物疗法，但 70% 至 90% 试图戒烟的吸烟者在治疗一年内恢复吸烟。女性可能更难实现和维持戒烟，因为女性戒烟者与曾经吸烟者的比例（戒烟率）较低（55.2%），低于男性（59.2%）。与男性相比，女性更容易出现吸烟并发症，尤其是肺癌。在美国，死于肺癌的女性人数比乳腺癌和结肠癌的总和还多。这些发现支持需要为女性吸烟者量身定制有效的治疗方法。其中一种方法可能包括使用黄体酮来增强目前可用的戒烟治疗。临床研究数据表明，对于月经周期规律的女性来说，在内源性血浆黄体酮水平较高时尝试戒烟的女性复吸的风险比在黄体酮水平较低时尝试戒烟的女性要低。我们小组的工作表明，黄体酮具有潜在的治疗作用，因为黄体酮可以减弱最近戒烟的女性吸烟者对香烟的渴望和吸烟带来的愉悦感。综上所述，这些发现使我们推测黄体酮可能会增强定期骑自行车的女性戒烟治疗的功效。这项概念验证研究将测试黄体酮治疗与安慰剂相比，联合透皮尼古丁贴片 (TNP) 治疗定期骑自行车的女性戒烟的安全性、耐受性和有效性。我们提议进行一项为期 8 周的试点临床试验，其中 50 名吸烟者将被随机分配到黄体酮（200 毫克，每天两次）或安慰剂组。所有参与者还将在参与研究期间接受 TNP 和戒烟行为治疗。吸烟者将在开始黄体酮和 TNP 治疗一周后尝试戒烟。主要结果指标是治疗结束时以及 1 个月和 3 个月随访时间点的长期戒烟率和 7 天点戒烟率。与更常用的合成孕激素相比，黄体酮是一种具有出色安全性的天然激素，将其用作女性新型戒烟药物是非常可行的。