Bupropion to Prevent Postpartum Smoking Relapse

描述：(申请人提供) 在这份R21拨款申请中，我们建议开展试点工作， 安非他酮SR预防的随机临床试验的基础 产后妇女吸烟复发。尽管许多女性在 怀孕，高达70%的人在分娩后一年内再次吸烟。 旨在防止分娩后复发的行为干预措施 只取得了有限的成功。与此同时，几项试验已经 表明安非他酮缓释片在促进戒断方面是安全有效的。 然而，目前还没有发表的研究评估这种药物的有效性。 安非他酮SR在特别脆弱的时期防止复发，如 作为产后期。我们的最终目标是评估 安非他酮SR预防妇女产后复发的临床研究 在怀孕期间戒烟，并在分娩时通过 一项双盲、安慰剂对照、随机临床试验。这项初步研究 将使我们能够开发和微调试验的方法和 展示我们注册和关注参与者的能力。 在这项研究中，我们将在分娩时随机招募50名妇女 分配他们接受安慰剂或安非他酮SR，为期12周。我们的目标是 对：a)招聘、样本采集和后续行动的测试方案；b) 开发调查工具；c)评估患者的依从性；d)估计 更大规模试验的资格、参与率和保留率。病人 调查人员将对治疗任务视而不见。中的主题 治疗组口服安非他酮300 mg，每日1次，共7天 然后是150 mg，共11周)。控制组的受试者将收到 安慰剂遵循相同的时间表。两组都将获得5 电话咨询会议，以鼓励维持戒烟 符合临床实践指南。患者的依从性将是 使用MEMS Track CapTM(Aprex Corporation，Union City，CA)进行测量，其 记录每次打开药瓶的时间和日期。自我报告 吸烟状态将用尿可替宁试纸(&lt；=100 ng/ml)在 产后12周和26周的基线和唾液可替宁(=30 ng/ml)。数据在 已知与戒烟相关的协变量和中介因素 并在基线、第12周和第26周至第26周收集复发情况 电话采访。如果在后续的随机试验中被证明有效， 我们正在测试的注册和实施策略可用于 实施县或州的计划。

DESCRIPTION: (provided by applicant) In this R21 grant application we propose to conduct pilot work that will lay the foundation for a randomized clinical trial of bupropion SR to prevent smoking relapse in postpartum women. Although many women quit smoking during pregnancy, up to 70 percent are smoking again within one year of delivery. Behavioral interventions designed to prevent relapse following delivery have met with only limited success. At the same time, several trials have demonstrated that bupropion SR is safe and effective in promoting cessation. However, there are no published studies evaluating the effectiveness of bupropion SR in preventing relapse during particularly vulnerable periods, such as the postpartum period. Our ultimate goal is to evaluate the effectiveness of bupropion SR in preventing relapse during the postpartum period among women who quit smoking during pregnancy and are abstinent at the time of delivery through a double-blind, placebo-controlled, randomized clinical trial. This pilot study will allow us to develop and fine tune the methodology for the trial and demonstrate our ability to enroll and follow participants. In this study, we will enroll 50 women at the time of delivery and randomly assign them to receive placebo or bupropion SR for 12 weeks. Our objectives are to: a) test protocols for recruitment, sample collection, and follow-up; b) develop survey instruments; c) evaluate patient compliance; and d) estimate eligibility, participation, and retention rates for the larger trial. Patients and investigators will be blind to treatment assignment. Subjects in the treatment group will receive 300mg bupropion SR (150mg QD am for 7 days followed by 150mg BID for 11 weeks). Subjects in the control group will receive placebo following the same schedule. Both groups will receive 5 telephone-counseling sessions to encourage the maintenance of cessation in accordance with clinical practice guidelines. Patient compliance will be measured using the MEMS Track CapTM (Aprex Corporation, Union City, CA), which records each time and date the medication bottle is opened. Self-reported smoking status will be validated with a urine cotinine dipstick (<=100ng/ml) at baseline and saliva cotinine (<=30ng/ml) at 12 and 26 weeks postpartum. Data on covariates and mediating factors known to be associated with smoking cessation and relapse will be collected at baseline, week 12 and week 26 through telephone interviews. If proven effective in a follow-up randomized trial, the enrollment and implementation strategies we are testing could be utilized to implement a county or state program.