Bupropion to Prevent Postpartum Smoking Relapse

描述：（申请人提供） 在这项R21赠款申请中，我们建议进行试点工作， 安非他酮缓释剂预防糖尿病的随机临床试验的基础 产后妇女吸烟复发。尽管许多女性在戒烟期间 在怀孕期间，高达70%的人在分娩后一年内再次吸烟。 旨在预防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，几次审判 证明安非他酮缓释剂在促进戒烟方面是安全有效的。 然而，没有发表的研究评估的有效性， 安非他酮缓释剂在特别脆弱的时期预防复发， 和产后时期一样我们的最终目标是评估 安非他酮缓释剂在预防产后复发的妇女中， 在怀孕期间戒烟，并在分娩时戒烟， 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方法， 展示我们招募和跟踪参与者的能力。 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缓释剂12周。我们的目标是 至：a）招募、样本采集和随访的测试方案; B） 开发调查工具; c）评估患者依从性;以及d）估计 大型试验的合格性、参与率和保留率。患者 并且研究者将对治疗分配不知情。受试者 治疗组给予安非他酮缓释片300 mg，150 mg，每日一次，连用7天 随后150 mg BID持续11周）。对照组受试者将接受 安慰剂按照相同的时间表。两组将获得5 电话咨询会议，以鼓励维持戒烟， 符合临床实践指南。患者依从性将是 使用MEMS Track CapTM（Aprex Corporation，联合城，CA）测量， 记录每次打开药瓶的时间和日期。自我报告 吸烟状态将通过尿液可替宁试纸（<= 100 ng/ml）进行验证， 基线和产后12周和26周的唾液可替宁（<= 30 ng/ml）。数据 已知与戒烟相关的协变量和中介因素 将在基线、第12周和第26周收集复发情况， 电话采访。如果在后续随机试验中证明有效， 我们正在测试的招生和实施策略可以用来 实施县或州计划。

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.