Novel Methods to Reduce Children's Secondhand Smoke Exposure

减少儿童接触二手烟的新方法

基本信息

批准号：
8444183
负责人：
Theodore Lee Wagener
金额：
$ 17.67万
依托单位：
UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-01-17 至 2014-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8444183
关键词：
Adherence Age Asthma Behavioral Caregivers Child Cigarette Cigarette Smoker Clinical Cotinine Counseling Data Education Environment Environmental Tobacco Smoke Exposure to Growth Health Health Benefit Home environment Household Incidence Individual Intervention Lead Life Lung Marketing Measures Mediation Mediator of activation protein Methods Motivation Nicotine Nicotine Dependence Nitrosamines Oral Tobacco Outcome Measure Pharmaceutic Aids Pharmaceutical Preparations Population Public Health Randomized Randomized Clinical Trials Reporting Research Saliva Salivary Sampling Serum Smoke Smokeless Smoker Smoking Smoking Behavior Sudden infant death syndrome Testing Tobacco Withdrawal Withdrawal Symptom age group arm base craving experience follow-up interest intervention effect middle ear disorder nicotine replacement novel potential reduced exposure products primary outcome public health relevance pulmonary function respiratory response satisfaction smoking cessation

项目摘要

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.

描述（由申请人提供）：儿童在所有年龄段的二手烟暴露（SHSE）中的次数最高，美国近60％的儿童暴露于二手烟。 SHSE降低了肺部生长，并增加了婴儿猝死，呼吸道疾病，中耳病和肺功能受损的发生率。目前旨在通过针对护理人员吸烟行为来减少儿童SHSE的临床干预措施通常无法在长期随访中减少儿童的股东。此外，只有29％的护理人员有兴趣在未来三个月内戒烟，而39％的看护人根本不感兴趣。因此，当前的方法不能作为减少儿童减少的唯一手段。应考虑其他方法。吸烟的护理人员使用无吐痰的，不耐尼古丁的产品可能就是一种方法。对于那些尚未准备好戒烟的人，在家里，汽车或儿童在场时使用无吐痰的，不可燃烧的尼古丁产品作为替代吸烟的选择，有可能创造100％的无烟环境。拟议的研究测试了尼古丁递送产品的两种替代形式：一种用于戒烟的药物辅助（Nicorette Lozenge），以前尚未测试过作为减少SHSE的一种手段，另一种是口服烟草产品（Ariva/Stonewall），目前是在吸烟环境中以吸烟的烟雾来销售的。两种产品都可以通过减少SHSE来带来重大的公共卫生益处。此外，在实现广泛使用之前，测试口服烟草产品很重要。鉴于烟草产品进入市场的不受管制的环境，评估独立研究中的行为和人口影响至关重要。该应用是对PA-09-047的回应，“促进烟草产品旨在减少危害”，该产品确定了研究产品（如Ariva/Stonewall）对个人和公共卫生的影响。当前研究的总体目的是确定上下文使用（即，在家庭，汽车或在儿童面前）含尼古丁的尼古丁含有吸烟和不感兴趣的戒烟的产品的产品是否有效减少儿童SHSE。我们将在吸烟且尚未准备好退出的护理人员样本中进行三臂（n = 30）试验随机临床试验。具体而言，护理人员将被随机接受减少SHSE减少教育咨询，而1）Ariva/Stonewall，2）Nicolette Lozenge或3）没有产品，仅限教育。研究产品将被提供6周。随访评估将在3、6和12周进行。主要结局指标将是儿童唾液可替宁（SHSE的客观指标）。其他结果措施包括护理人员唾液可替宁，渴望和戒断症状，护理人员满意度和对产品的依从性以及产品对护理人员戒烟动机的影响。这项研究的结果将有助于确定护理人员使用无吐痰的，不可固化的尼古丁产品的影响和可行性，以减少儿童的股权。