Novel Methods to Reduce Children's Secondhand Smoke Exposure

描述(由申请人提供)：在所有年龄段中，儿童经历的二手烟暴露(SHSE)量最高，美国近60%的儿童暴露在二手烟中。SHSE抑制肺生长，增加婴儿猝死、呼吸系统疾病、中耳疾病和肺功能受损的发生率。目前旨在通过针对照顾者吸烟行为来减少儿童SHSE的临床干预措施，在长期随访中往往无法减少儿童的SHSE。此外，只有29%的照顾者有兴趣在未来三个月内戒烟，而39%的人根本没有兴趣戒烟。因此，目前的方法不能作为减少儿童SHSE的唯一手段。应该考虑其他方法。吸烟的照顾者使用无唾液、不可燃烧的尼古丁产品可能就是这样一种方法。对于那些不准备戒烟的人来说，选择在家里、车里或在儿童面前使用无唾液、不可燃烧的尼古丁产品作为吸烟的替代品，可能会创造一个100%无烟的环境。这项拟议的研究测试了两种替代形式的尼古丁释放产品：一种是药物戒烟助剂(Nicorette Lozenger)，以前没有被测试为减少SHSE的方法；另一种是口服烟草产品(Ariva/Stonewall)，目前在无烟环境中作为香烟的“替代品”销售给吸烟者。这两种产品都可以通过减少SHSE而对公众健康产生重大好处。此外，重要的是在口服烟草产品获得广泛使用之前对其进行测试。鉴于烟草产品进入市场的不受监管的环境，在独立研究中评估行为和人口影响是至关重要的。这项申请是对PA-09-047《测试促进降低危害的烟草产品》的响应，其中确定了检查Ariva/Stonewall等产品对个人和公共健康的影响。目前这项研究的总体目标是确定吸烟和不想戒烟的照顾者在情境下(即在家中、车里或在儿童面前)使用含有尼古丁的产品是否对减少儿童肥胖症有效。我们将在吸烟和不准备戒烟的照顾者中进行一项三臂(每臂n=30)试点随机临床试验。具体地说，照顾者将随机接受SHSE减少教育咨询，并接受1)Ariva/Stonewall，2)Nicolette含片，或3)无产品，仅接受教育的对照。学习产品将提供6周。后续评估将在3周、6周和12周进行。主要的结果衡量标准将是儿童唾液可替宁(SHSE的客观指标)。其他结果指标包括照顾者唾液可替宁、渴望和戒断症状、照顾者满意度和对产品的坚持，以及产品对照顾者戒烟动机的影响。这项研究的结果将有助于确定照顾者使用无唾液、不可燃烧的尼古丁产品作为减少儿童粪便的方法的效果和可行性。

DESCRIPTION (provided by applicant): Children experience the highest amount of secondhand smoke exposure (SHSe) of all age groups, with nearly 60% of children in the U.S. exposed to secondhand smoke. SHSe decreases lung growth and increases the incidence of sudden infant death, respiratory illness, middle-ear disease, and impaired pulmonary function. Current clinical interventions aimed at reducing children's SHSe by targeting caregiver smoking behavior often fail to reduce children's SHSe at long-term follow-ups. Moreover, only 29% of caregivers are interested in quitting smoking in the next three months, while 39% are not interested in quitting at all. Thus, current methods cannot be relied upon as the sole means of SHSe reduction for children. Other methods should be considered. The use of spit-less, non-combustible nicotine-containing products by caregivers who smoke may be one such method. For those who are not ready to quit smoking, the option of using spit-less, non-combustible nicotine- containing products as replacements for smoking when in the home, car, or in the presence of children has the potential to create a 100% smoke-free environment. The proposed study tests two alternative forms of nicotine delivery products: one a pharmaceutical aid to cessation (Nicorette Lozenge) that has not been previously tested as a means of SHSe reduction and the other an oral tobacco product (Ariva/Stonewall), currently is marketed to smokers as a "substitute" for cigarettes when in smoke-free environments. Both products could offer a significant public health benefit by reducing SHSe. Furthermore, it is important to test oral tobacco products, before they achieve widespread use. Given the unregulated environment in which tobacco products come to the market, it is critical to evaluate the behavioral and population effects in independent studies. This application is in response to PA-09-047, "Testing Tobacco Products Promoted to Reduce Harm," which identifies examining the impact of products, like Ariva/Stonewall, on individual and public health. The overall aim of the current study is to determine if the contextual use (i.e., when in the home, car, or in presence of the child) of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing child SHSe. We will conduct a three arm (n=30 in each arm) pilot randomized clinical trial in a sample of caregivers who smoke and who are not ready to quit. Specifically, caregivers will be randomized to receive SHSe reduction education counseling and either 1) Ariva/Stonewall, 2) Nicolette lozenge, or 3) no product, education-only control. Study products will be provided for 6 weeks. Follow-up assessments will occur at 3, 6, and 12 weeks. The primary outcome measure will be child salivary cotinine (an objective indicator of SHSe). Other outcome measures include caregiver saliva cotinine, craving and withdrawal symptoms, caregiver satisfaction and adherence to product, and product impact on caregiver motivation to quit. The results from this study will help determine the effects and feasibility of using spit-less, non-combustible nicotine-containing products by caregivers as a method of reducing children's SHSe.