Bupropion for the prevention of postpartum smoking relapse

项目摘要-安非他酮预防产后吸烟复发 产后吸烟复吸率十多年来一直停滞不前，其中约50%的人 在怀孕期间能够戒烟的妇女在怀孕后的头几个月内复发 分娩母亲吸烟导致各种负面健康的显着增加 对母亲和孩子都有影响。在怀孕前三个月吸烟的女性中，55%戒烟 在怀孕期间。接下来的产后时期对女性来说是一个独特而具有挑战性的时期， 保持戒烟。几个可改变的危险因素可预测产后吸烟复发 包括抑郁症、体重问题和吸烟相关疾病。安非他酮是唯一适合 解决这些复发相关的风险因素在产后妇女。针对这些多方面的治疗方法- 与产后吸烟复吸有关的多方面障碍可能导致持续戒烟。安非他酮具有 在一般人群中证明戒烟的有效性，六个月后戒烟率翻了一番。虽然不那么 在文献中探索，安非他酮治疗预防吸烟复吸已被证明延迟， 接受安非他酮治疗的患者复发。然而，使用安非他酮预防产后吸烟复吸， 没有被探索过。因此，我们的中心假设是，安非他酮将防止产后吸烟复发 在怀孕期间戒烟的女性中。为了探索这一假设，我们将进行一个双臂， 采用严格、经验证和可重现方法的双盲、安慰剂对照随机临床试验 这将由一个熟悉这一人群的有经验的调查人员小组执行。我们将 招募在得知自己怀孕后戒烟并有动机留下来的孕妇（n=230） 产后禁欲受试者将随机接受缓释安非他酮（活性300 mg或 从产后4至10天开始至随机化后12周，每天一次安慰剂）。所有参与者将 完成相同的数据收集程序（例如，激素和可替宁生物样品采集 分析和完成验证的问卷），从4 - 10周每周一次 随机化后12周以及随机化后第12、24、36和52周。 干预依从性将通过高效液相色谱法进行定量确认， 生物样本这项由高技能和富有成效的团队进行的新研究的影响将 通过扩大已知药物疗法在其中的作用，直接推进当前的科学状态。 这是一个非常脆弱的群体。此外，如果我们的中心假设得到支持， 干预措施在临床上适用，相关，可以立即进行。

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.