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赠款申请中，我们建议进行一项试验性可行性研究，为未来的随机对照试验做准备，该试验测试抗抑郁药对产后妇女中戒烟的效果。孕产妇的吸烟增加了许多原因，包括婴儿猝死综合症，呼吸道感染，中耳炎和哮喘的死亡风险。减少孕妇和产后妇女的吸烟是2010年的全国性健康目标。对这种人群的最新戒烟治疗，行为咨询，尤其是在浓烟中，取得了适度的成功。添加药物治疗是非孕妇戒烟计划的标准组成部分，可能会改善围产期环境中的戒烟率，但由于担心损害胎儿或母乳喂养的婴儿，其使用受到限制。持续释放（SR）安非他酮可有效地停止非怀孕的成年人，并为产后妇女提供其他潜在的好处（例如，情绪稳定和体重管理）。新的数据表明，人类母乳中分泌的药物最少，为在母乳中测试安非他酮的母乳中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尺寸试验的可行性：（1）完善招聘，保留，干预和评估协议； （2）估计可实现的入学率和保留率； （3）估计效果大小（药物和安慰剂组之间的戒烟率差异），以计划全功率试验的样本量。为了实现这些目的，我们将进行一项试验性双盲安慰剂对照临床试验，以比较40个安慰剂150-300 mg/天的短期疗效与40个产后乳酸女性的安慰剂相比，这些妇女在怀孕最后一周的时间每天吸烟或> 5次香烟。为了利用婴儿出生的可教时刻，将在交通后住院期间招募受试者。所有受试者都将接受“最佳实践”的行为戒烟咨询。结果在2、4、8和12周进行评估，包括戒烟（7天点 - 占争分性的戒烟，由唾液Cotinine验证的戒烟验证），抑郁症和抑郁症症状，抑郁症的症状及其对母亲（E.G.，E。G.，E。G.，E。G.，E.G.，E.G.G.）的耐受性，婴儿睡眠，烦躁和喂养的报告。