Bupropion for Smoking Cessation in Postpartum Women

安非他酮用于产后妇女戒烟

• 批准号: 7244066
• 负责人: NANCY A RIGOTTI
• 金额: $ 21.24万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-05 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7244066
• 关键词: Adherence; Adult; Adverse effects; Antidepressive Agents; Applications Grants; Arts; Asthma; Behavioral; Birth; Birthing Centers; Blood; Body Weight decreased; Breast Feeding; Bupropion; Cause of Death; Cigarette; Clinical; Clinical Pharmacology; Clinical Research; Collaborations; Consumption; Controlled Clinical Trials; Cotinine; Counseling; Data; Doctor of Philosophy; Double-Blind Method; Enrollment; Exposure to; Feasibility Studies; Fetus; Funding; Future; Goals; Health; Hospitalization; Hospitals; Human; Human Milk; Infant; Intervention; Massachusetts; Measures; Medical; Modality; Moods; Morbidity - disease rate; Mothers; Nicotine; Otitis Media; Outcome; Outcome Measure; Participant; Patient currently pregnant; Perinatal; Persons; Pharmaceutical Preparations; Pharmacotherapy; Pilot Projects; Placebo Control; Placebos; Population; Postpartum Depression; Postpartum Period; Postpartum Women; Pregnancy; Prevalence; Protocols documentation; Randomized; Randomized Controlled Trials; Rate; Recruitment Activity; Reporting; Research; Research Personnel; Respiratory Tract Infections; Risk; Safety; Saliva; Sample Size; Site; Sleep; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Standards of Weights and Measures; Sudden infant death syndrome; Target Populations; Telephone; Testing; Time; Tobacco; Uncertainty; Urine; Week; Weight; Weight Gain; Withholding Treatment; Woman; Women' s Group; Women' s Health; Work; base; dalton; day; depressive symptoms; double-blind placebo controlled trial; experience; feeding; fetal tobacco exposure; follow-up; improved; innovation; maternal cigarette smoking; medication compliance; mortality; neglect; novel strategies; programs; size; smoking cessation; success; tobacco abstinence; treatment center

DESCRIPTION (provided by applicant): In this R21 grant application, we propose to conduct a pilot feasibility study to prepare for a future randomized controlled trial testing the efficacy of the antidepressant bupropion for smoking cessation in postpartum women. Maternal smoking increases the risk of infant morbidity and mortality from many causes, including sudden infant death syndrome, respiratory infections, otitis media, and asthma. Reducing smoking in pregnant and postpartum women is a national health objective for 2010. The state-of-the-art smoking cessation treatment for this population, behavioral counseling, has modest success especially in heavy smokers. Adding pharmacotherapy, a standard component of smoking cessation programs in nonpregnant adults, might improve smoking cessation rates in the peripartum setting, but its use has been limited by concern about harming a fetus or breastfed infant. Sustained-release (SR) bupropion is effective for smoking cessation in nonpregnant adults and offers other potential benefits to postpartum women (e.g., mood stabilization and weight management). New data show that a minimal amount of the drug is secreted in human breast milk, providing a compelling rationale for testing bupropion in breastfeeding postpartum smokers. This pilot project will assess the feasibility of a future full-scale trial by: (1) refining recruitment, retention, intervention, and assessment protocols; (2) estimating achievable enrollment and retention rates; and (3) estimating the effect size (difference in smoking cessation rates between drug and placebo groups) in order to plan the sample size for a fully-powered trial. To achieve these aims, we will conduct a pilot randomized double-blind placebo-controlled clinical trial to compare the short-term efficacy of 8 weeks of bupropion SR 150-300 mg/day vs. placebo in 40 postpartum lactating women who smoked equal to or >5 cigarettes per day in the last week of pregnancy. Subjects will be recruited during their post-delivery hospitalization in order to take advantage of the teachable moment of an infant's birth. All subjects will receive "best practice' behavioral smoking cessation counseling. Outcomes, assessed at 2, 4, 8 and 12 weeks postpartum, will include smoking cessation (7-day point-prevalence tobacco abstinence validated by saliva cotinine), depression symptoms, and the tolerability of bupropion in the mother (e.g., medication adherence, adverse effects) and infant (weight gain and maternal report of infant sleep, irritability, and feeding). A substudy will assess breastfed infants' exposure to bupropion. If this pilot is successful, we plan to test the safety and efficacy of bupropion SR in a future full-scale randomized double-blind placebo-controlled trial for smoking cessation in postpartum women.

描述（由申请人提供）： 在此 R21 拨款申请中，我们建议进行一项试点可行性研究，为未来测试抗抑郁药安非他酮对产后妇女戒烟的功效的随机对照试验做准备。母亲吸烟会增加婴儿发病和死亡的风险，原因有很多，包括婴儿猝死综合症、呼吸道感染、中耳炎和哮喘。减少孕妇和产后妇女吸烟是 2010 年的国家健康目标。针对这一人群的最先进的戒烟治疗——行为咨询——取得了一定的成功，尤其是对重度吸烟者。添加药物治疗是非妊娠成人戒烟计划的标准组成部分，可能会提高围产期的戒烟率，但由于担心伤害胎儿或母乳喂养的婴儿，其使用受到限制。缓释（SR）安非他酮对于非怀孕成人戒烟有效，并为产后妇女提供其他潜在益处（例如稳定情绪和体重管理）。新数据显示，人类母乳中会分泌极少量的该药物，这为在母乳喂养的产后吸烟者中测试安非他酮提供了令人信服的理由。该试点项目将通过以下方式评估未来全面试验的可行性：（1）完善招募、保留、干预和评估方案； (2) 估计可实现的入学率和保留率； (3) 估计效应大小（药物组和安慰剂组之间戒烟率的差异），以便规划全功效试验的样本量。为了实现这些目标，我们将进行一项随机双盲安慰剂对照临床试验，以比较 40 名产后哺乳期妇女吸烟量相当于 8 周的安非他酮 SR 150-300 毫克/天与安慰剂的短期疗效。或在怀孕最后一周每天吸烟超过 5 支。受试者将在产后住院期间被招募，以便利用婴儿出生的教学时刻。所有受试者都将接受“最佳实践”行为戒烟咨询。在产后 2、4、8 和 12 周评估的结果将包括戒烟（通过唾液可替宁验证的 7 天点流行率戒烟）、抑郁症状和母亲（例如药物依从性、不良反应）和婴儿（体重增加和母亲对婴儿睡眠、烦躁和喂养的报告）对安非他酮的耐受性。一项子研究将评估母乳喂养的婴儿接触安非他酮的情况，如果该试点成功，我们计划在未来针对产后妇女戒烟的全面随机双盲安慰剂对照试验中测试安非他酮 SR 的安全性和有效性。