Novel Methods to Reduce Children's Secondhand Smoke Exposure II (EZII)
|ClinicalTrials.gov Identifier: NCT01896518|
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Secondhand Smoke||Drug: Nicotine polacrilex Drug: Tobacco lozenge||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Novel Methods to Reduce Children's Secondhand Smoke Exposure II|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|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
- Change in Child Salivary Cotinine [ Time Frame: 3, 6, and 12 weeks ]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 ]We will collect both parent and child spirometry data and compare changes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896518
|United States, Oklahoma|
|The Children's Hospital at OU Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Theodore Wagener, Ph.D.||OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center|