Progesterone and Postpartum Relapse to Smoking

说明(申请人提供)：绝大多数在怀孕期间戒烟的妇女在产后复发。缺乏复发预防干预措施。孕酮是一种女性性激素，在动物和临床文献中都被认为是对成瘾行为的保护作用。这种荷尔蒙在怀孕期间急剧增加(可能起到保护作用)，然后在分娩后迅速下降。因此，这项R21应用的主要目标是调查外源性孕酮(辅以复发预防咨询)对新妈妈产后复发的潜在疗效。我们还将确定加强遵守情况监测和确定影响结果的附带因素的可行性--这两项工作都将完成。 为了准备更大的R01支撑架，严格控制。为了实现这些目标，我们将招募怀孕33-36周的孕妇，她们在怀孕期间戒烟，并有动力在分娩后保持戒烟。在分娩时，妇女将被随机分配接受四周的活动(n=20)或安慰剂(n=20)外源性黄体酮，从产后第四天开始。参与者将完成每周一次的临床访问，直到产后12周，以收集有关吸烟状况和依从性的数据，测量血清孕酮水平，并接受行为咨询。本研究有几个创新之处。具体地说，我们将首先进行一项随机临床试验，以确定产后服用黄体酮是否可以消除或降低产后吸烟复发的风险，同时利用每日电子数据捕获方案。因此，这项研究将推进性激素在成瘾行为中的作用的文献，并直接为未来针对新妈妈的复发预防研究提供参考。

DESCRIPTION (provided by applicant): The vast majority of women who quit smoking during pregnancy relapse during the postpartum period. Relapse prevention interventions are lacking. Progesterone, a female sex hormone, has been implicated in both the animal and clinical literature as being protective against addictive behaviors. This hormone increases dramatically during pregnancy (possibly offering a protective effect), then plummets soon after delivery. Therefore, the primary goal of this R21 application is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. We will also determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes - both of which will be done in preparation for a larger R01 supported rigorously controlled. To address these goals we will recruit pregnant women at gestational weeks 33-36 who have quit smoking during pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery, women will be randomly assigned to receive four weeks of active (n=20) or placebo (n=20) exogenous progesterone starting on the fourth day postpartum. Participants will complete weekly clinic visits until 12 weeks postpartum to collect data on smoking status and protocol compliance, measure serum progesterone levels, and receive behavioral counseling. This study has several innovative aspects. Specifically, we will be the first to conduct a randomized clinical trial to determine whether progesterone administration postpartum can eliminate or reduce risk for postpartum smoking relapse while utilizing a daily electronic data capture protocol. This study will, therefore, advance the literature on the role of sex hormones in addictive behaviors and directly inform future relapse prevention studies for new mothers.