Novel Methods to Reduce Children's Secondhand Smoke Exposure

减少儿童接触二手烟的新方法

• 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
• 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

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）：在所有年龄段中，儿童接触二手烟 (SHSe) 的数量最多，美国近 60% 的儿童接触二手烟。 SHSe 会降低肺部生长，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。目前旨在通过针对看护者吸烟行为来降低儿童 SHSe 的临床干预措施在长期随访中往往无法降低儿童的 SHSe。此外，只有 29% 的护理人员有兴趣在未来三个月内戒烟，而 39% 的护理人员根本没有兴趣戒烟。因此，目前的方法不能作为儿童减少 SHSe 的唯一手段。应考虑其他方法。吸烟的护理人员使用不吐痰、不可燃的含尼古丁产品可能就是其中一种方法。对于那些还没有准备好戒烟的人来说，选择使用不吐痰、不可燃的含尼古丁产品作为在家中、车内或有儿童在场时吸烟的替代品，有可能创造 100% 的戒烟效果。无烟环境。拟议的研究测试了两种替代形式的尼古丁输送产品：一种是药物戒烟辅助剂（Nicorette Lozenge），此前尚未作为减少 SHSe 的手段进行过测试；另一种是口服烟草产品（Ariva/Stonewall），目前已上市对于吸烟者来说，在无烟环境中作为香烟的“替代品”。这两种产品都可以通过减少 SHSe 来提供显着的公共健康益处。此外，在口腔烟草产品广泛使用之前对其进行测试也很重要。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群影响至关重要。此应用程序是为了响应 PA-09-047，“测试烟草产品促进减少危害”，其中确定了检查产品（如 Ariva/Stonewall）对个人和公共健康的影响。本研究的总体目标是确定吸烟且无意戒烟的护理人员在特定情况下（即在家中、车内或有孩子在场时）使用含尼古丁产品是否有效减少儿童SHSe。我们将对吸烟且尚未准备好戒烟的护理人员样本进行三组（每组 n=30）试点随机临床试验。具体来说，护理人员将被随机接受 SHSe 减少教育咨询和 1) Ariva/Stonewall，2) Nicolette 含片，或 3) 无产品、纯教育对照。研究产品将提供为期 6 周。后续评估将在第 3、6 和 12 周进行。主要结果指标是儿童唾液可替宁（SHSe 的客观指标）。其他结果指标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不吐痰、不可燃的含尼古丁产品作为减少儿童 SHSe 的方法的效果和可行性。