Novel Methods to Reduce Children's Secondhand Smoke Exposure II (EZII)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|