Bupropion for the prevention of postpartum smoking relapse

项目摘要-安非他酮预防产后吸烟复发 产后吸烟复发率十多年来一直停滞不前，其中约50% 哪些人能够在怀孕期间实现戒烟，并在怀孕后头几个月内复发 分娩。母亲吸烟会导致多种不良健康状况的显著增加 对母亲和孩子都有影响。在怀孕前三个月吸烟的女性中，55%的人戒烟 在她们怀孕期间。接下来的产后期对女性来说是一个独特而具有挑战性的时期 坚持戒烟。几个可改变的危险因素可预测产后吸烟复发 包括抑郁、体重问题和吸烟相关症状。安非他酮是唯一适合于 在产后妇女中解决这些与复发相关的风险因素。治疗这些多方面的- 与产后吸烟复发有关的多方面障碍可能会导致持续戒烟。安非他酮有 在普通人群中证明了戒烟的有效性，戒烟率在6个月内翻了一番。虽然少了一些 文献研究表明，安非他酮对预防吸烟复发有延迟作用。 接受安非他酮治疗的患者复发。然而，安非他酮用于预防产后吸烟复发 没有被探索过。因此，我们的中心假设是安非他酮可以防止产后吸烟复发。 在怀孕期间戒烟的女性中。为了探索这一假设，我们将进行一项双臂实验， 使用严格、有效和可重复性方法的双盲、安慰剂对照随机临床试验 这将由一组熟悉这一人群的经验丰富的调查人员实施。我们会 招募孕妇(n=230)，她们在得知怀孕后戒烟并有动力留下来 产后禁欲。参与者将被随机接受安非他酮缓释剂(活性300 mg或 安慰剂每天一次，从产后4至10天开始，到随机分组后12周)。所有参与者将 完成相同的数据收集程序(例如，激素和可替宁的生物样本收集 分析和完成有效问卷)在基线(妊娠36周)，每周4至10 产后12天至随机化后12周，以及随机化后12、24、36和52周。 干预依从性将通过使用高效液相色谱进行定量确认 生物样本。这项由高技能和多产的团队进行的新颖研究的意义将 通过扩展已知药物疗法的作用直接推进科学的当前状态 这些高度脆弱的人群。此外，如果我们的中心假设得到支持，这一点的传播 干预在临床上是适用的，相关的，并可能立即进行。

Project Abstract – Bupropion for the Prevention of Postpartum Smoking Relapse Postpartum smoking relapse rates have remained stagnant for over a decade with approximately 50% of those who are able to achieve smoking abstinence during pregnancy relapsing within the first few months after childbirth. Maternal cigarette smoking results in a significant increase in a variety of negative health consequences for both mother and child. Of women who smoke three months prior to pregnancy, 55% quit during their pregnancy. The following postpartum period presents a unique and challenging time for women to maintain smoking abstinence. Several modifiable risk factors are predictive of postpartum smoking relapse including depression, weight concerns, and smoking related symptomatology. Bupropion is uniquely suited to address each of these relapse related risk factors in postpartum women. Treatments that address these multi- faceted barriers related to postpartum smoking relapse may lead to sustained abstinence. Bupropion has proven efficacy for smoking cessation in the general population, doubling quit rates at six months. Though less explored in the literature, bupropion treatment for smoking relapse prevention has demonstrated a delay to relapse in those receiving bupropion. Yet the use of bupropion for postpartum smoking relapse prevention has not been explored. Therefore, our central hypothesis is that bupropion will prevent postpartum smoking relapse among women who quit smoking during pregnancy. To explore this hypothesis, we will conduct a two-arm, double-blind, placebo-controlled randomized clinical trial using rigorous, validated and reproducible methods that will be implemented by a team of experienced investigators who are familiar with this population. We will enroll pregnant women (n=230) who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. Participants will be randomized to receive extended release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post randomization). All participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post randomization and at weeks 12, 24, 36 and 52 post randomization. Intervention adherence will be confirmed quantitatively via high performance liquid chromatography using biological samples. The implications of this novel study, pursued by a highly skilled and productive team, will directly advance the current state of the science by expanding on the role of a known pharmacotherapy within this highly vulnerable population. Further, should our central hypothesis be supported, the dissemination of this intervention is clinically applicable, relevant and may be immediately pursued.