SCHEDULED, GRADUAL REDUCTION FOR PREGNANT SMOKERS

怀孕期间吸烟与胎儿、新生儿和母亲的风险增加有关。自助戒烟计划可能非常适合怀孕吸烟者，因为大多数吸烟者更喜欢自己戒烟，基于小组的戒烟模式对怀孕吸烟者的吸引力有限，并且药物方法（尼古丁替代，安非他酮）通常在怀孕期间禁忌。在这个I期项目中，我们建议开发和评估一个自助戒烟计划，怀孕吸烟者使用的技术和方法，基于计算机的，预定的毕业减少（SGR）最初由我们的研究小组开创。该计划将包括两个组成部分：（l）一个易于使用的，信用卡大小的LifeSign计算机，它执行SGR协议;和（2）一个计划指南，专门针对怀孕吸烟者的独特兴趣和问题。在第一阶段，将在一项为期10周的可行性研究中评估孕妇吸烟者生命体征计划的原型，其中N=100名受试者被随机分配到两种情况之一中：（1）生命体征;或（2）最小接触自助控制。关注的主要结局指标包括10周随访时经生物学验证的戒烟率以及吸烟率和一氧化碳水平较基线的降低。可行性将根据处理和过程结果以及用户满意度进行评估。在第二阶段，该计划的第二代原型将在更大规模的临床试验中开发和评估。总的来说，该项目将允许开发和评估一种新的自助戒烟干预措施，用于孕妇吸烟者，这是一个需要扩大戒烟治疗选择的目标人群。建议的商业应用：尽管吸烟的风险，最近的数据表明，高达14%的孕妇在怀孕期间吸烟。这个项目将评估一个重要的自助戒烟方法，怀孕吸烟者使用计算机为基础的计划逐步减少。拟议的产品将为怀孕吸烟者提供一种易于使用的治疗选择，并可能作为一种有效的公共卫生工具具有广泛的实用性。

Smoking during pregnancy is associated with increased risk for the fetus, newborn infant, and mother. Self-help smoking cessation programs may be ideally suited for pregnant smokers given that most smokers prefer to quit on their own, group-based models of smoking cessation have limited appeal to pregnant smokers, and pharmacological methods (nicotine replacement, buproprion) are generally contraindicated during pregnancy. In this Phase l project, we propose to develop and evaluate a self-help smoking cessation program for pregnant smokers using the technology and methods of computer-based, scheduled graduation reduction (SGR) originally pioneered by our research group. The program will consist of two components: (l) an easy to use, credit-card sized LifeSign computer which implements a SGR protocol; and (2) a Program Guide tailored to the unique interests and issues of pregnant smokers. During Phase I, a prototype of the LifeSign Program for Pregnant Smokers will be evaluated in a 10-week feasibility study with N=100 subjects randomly assigned to one of two conditions: (l) LifeSign; or (2) minimal contact self-help control. The primary outcome measures of interest include biologically- verified abstinence rates at 10-week follow-up and reductions from baseline in smoking rate and carbon monoxide levels. Feasibility will be evaluated on the basis of treatment and process outcomes and measures of user satisfaction. During Phase II, a second generation prototype of the program will be developed and evaluated in a larger scale clinical trial. Overall, this project will allow for the development and evaluation of a novel self-help smoking cessation intervention for pregnant smokers, a target population in need of expanded smoking cessation treatment options. PROPOSED COMMERCIAL APPLICATIONS: Despite the risks of smoking, recent data indicate that up to 14% of pregnant women smoke during pregnancy. This project will evaluate an important self-help smoking cessation approach for pregnant smokers using computer-based scheduled gradual reduction. The proposed product will offer an easy to use treatment option for pregnant smokers and may have broad utility as an effective public health tool.