Novel Methods to Reduce Children's Secondhand Smoke Exposure II (EZII)
The overall aim of the current study is to determine if the use of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing children's secondhand smoke exposure.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Novel Methods to Reduce Children's Secondhand Smoke Exposure II|
- Change in Child Salivary Cotinine [ Time Frame: 3, 6, and 12 weeks ] [ Designated as safety issue: No ]Child salivary cotinine will be measured to assess the level of secondhand smoke exposure. We will measure the change throughout the study.
- Change in Parent and Child Lung Function [ Time Frame: 3, 6, 12 weeks ] [ Designated as safety issue: No ]We will collect both parent and child spirometry data and compare changes.
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|No Intervention: Counseling|
Experimental: Nicotine lozenge
Participants will receive nicotine lozenge to use as needed for 12 weeks.
|Drug: Nicotine polacrilex|
Experimental: Tobacco lozenge
Participants will receive tobacco lozenge to use as needed for 12 weeks.
|Drug: Tobacco lozenge|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01896518
|Contact: Leslie Driskill, MS||(405)firstname.lastname@example.org|
|Contact: Noor Tahirkheli, BS||(405)271-8001 ext email@example.com|
|United States, Oklahoma|
|The Children's Hospital at OU Medical Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Leslie Driskill|
|Principal Investigator:||Theodore Wagener, Ph.D.||OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center|