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Progesterone for Postpartum Smokers: Feasibility, Breastfeeding and Infant Safety

孕酮用于产后吸烟者：可行性、母乳喂养和婴儿安全

基本信息

批准号：
8661738
负责人：
ARIADNA FORRAY
金额：
$ 21.35万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-05-15 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8661738
关键词：
Abstinence Addictive Behavior Adverse event Affect Antismoking Attenuated Behavioral Breast Feeding Cessation of life Child Childbirth Cigarette Clinical Research Clinical Trials Conceptions Counseling Country Data Drops Epidemiologic Studies Exploratory/Developmental Grant Feasibility Studies Female Growth Habits Health Hormonal Human Milk Infant Intervention Lactation Lead Medical Mental Health Mothers Perinatal Pharmaceutical Preparations Pharmacotherapy Pilot Projects Placebo Control Placebos Population Postpartum Period Postpartum Women Pregnancy Pregnancy Outcome Premature Birth Prevention Prevention strategy Production Progesterone Protocols documentation Provider Randomized Randomized Clinical Trials Recording of previous events Relapse Relative (related person)Rewards Risk Role Safety Smoke Smoker Smoking Smoking Cessation Intervention Testing Therapeutic Therapeutic Agents Therapeutic Intervention Tobacco Dependence Woman Work addiction cigarette smoking combat craving disorder later incidence prevention effective therapy experience follow-up infant morbidity/mortality maternal cigarette smoking mortality neonatal exposure novel offspring preclinical study pregnant prevent public health relevance smoking cessation smoking prevalence smoking relapse success successful intervention uptake young woman

项目摘要

DESCRIPTION (provided by applicant): Smoking is the main preventable cause of mortality in Western countries, contributing to over 430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women often decrease smoking in pregnancy, when endogenous progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. Postpartum women who smoke increase their health risks and that of their offspring. No behavioral or medication treatments are clearly established as safe and effective for smoking cessation in postpartum women. Further, there is reluctance on the part of both postpartum women and obstetrical providers to use traditional anti-smoking medications since this may lead to neonatal exposure if the mother is breastfeeding. Given these concerns, there is a great need to develop relapse prevention treatments that are tailored for postpartum women with pre-conception smoking. Data from preclinical and clinical studies suggest that progesterone may be effective in preventing relapse to smoking in non-postpartum women, and may be acceptable to postpartum women and their providers. Prior work has shown that exogenous administration attenuates both craving for cigarettes and the subjective rewarding effects of smoking among recently abstinent female smokers. These findings led us to hypothesize that progesterone may have efficacy as a relapse prevention treatment for postpartum women. We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of progesterone. This will be a feasibility study that will compare progesterone (200 mg/day) to placebo for relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety, including the potential effects on breastfeeding and infants exposed via breast milk, in addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at follow-up, 3-months after the end of the protocol. If data suggest efficacy for progesterone, we will test the intervention i a larger clinical trial. Progesterone treatment, if ultimately found to be therapeutic, could be deployed in an obstetrical setting by providers that are accustomed to the use of progesterone as a therapeutic agent. Accordingly, the proposed project has the potential to make a major impact on the health of new mothers and their children.

描述（由申请人提供）：在西方国家，吸烟是主要的可预防的死亡原因，仅在美国每年就造成43万多人死亡。临床和流行病学研究表明，妇女往往减少吸烟怀孕时，内源性孕酮水平高。然而，至少有一半的人在分娩后的几周内恢复了孕前吸烟水平，当孕酮水平下降时。产后妇女吸烟会增加她们及其后代的健康风险。没有明确的行为或药物治疗是安全有效的产后妇女戒烟。此外，产后妇女和产科提供者都不愿意使用传统的戒烟药物，因为如果母亲正在哺乳，这可能导致新生儿接触。鉴于这些问题，非常需要开发针对怀孕前吸烟的产后妇女的复发预防治疗。来自临床前和临床研究的数据表明，孕激素可能有效地防止非产后妇女吸烟复发，产后妇女及其提供者可能接受。先前的工作表明，外源性管理衰减香烟的渴望和吸烟的主观奖励的影响，最近戒烟的女性吸烟者。这些发现使我们假设孕激素可能对产后妇女的复发预防治疗有效。我们建议进行一项为期8周的随机试验性研究，以评估黄体酮的安全性和初步疗效。这将是一项可行性研究，将在40名产后吸烟者中比较孕酮（200 mg/天）与安慰剂预防复发的效果。我们将评估可行性和安全性，包括对母乳喂养和通过母乳暴露的婴儿的潜在影响，以及治疗8周后和方案结束后3个月随访时的7天戒烟率。如果数据表明黄体酮的疗效，我们将在更大的临床试验中测试干预措施。如果最终发现孕酮治疗是治疗性的，则可以由习惯于使用孕酮作为治疗剂的提供者在产科环境中部署。因此，拟议的项目有可能对新母亲及其子女的健康产生重大影响。