|Grant Number:||1R21CA164521-01A1 Interpret this number|
|Primary Investigator:||Wagener, Theodore|
|Organization:||University Of Oklahoma Hlth Sciences Ctr|
|Project Title:||Novel Methods to Reduce Children's Secondhand Smoke Exposure|
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.