Preliminary Investigation of Novel Methods to Reduce Children's Secondhand Smoke Exposure (EZI)
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|ClinicalTrials.gov Identifier: NCT01935713|
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : May 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Secondhand Smoke||Drug: Nicotine polacrilex Drug: Electronic Cigarette Drug: Dissolvable Tobacco Lozenge||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Novel Methods to Reduce Children's Secondhand Smoke Exposure I|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Electronic Cigarette
Participants received the electronic cigarette for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.
Drug: Electronic Cigarette
Participants were given an e-cigarette starter kit, charging case, and cartridges in either 12mg or 16 mg nicotine, depending on their current amount of cigarettes smoked per day.
Other Name: Smoke Tip
Experimental: Dissolvable Tobacco Lozenge
Participants received the dissolvable tobacco lozenge for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.
Drug: Dissolvable Tobacco Lozenge
Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, >2 packs per day).
Other Name: Ariva, Stonewall
Experimental: Dissolvable Nicotine Lozenge (Nicorette)
Participants received the dissolvable nicotine lozenge (Nicorette) for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.
Drug: Nicotine polacrilex
Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.
Other Name: Nicorette
- Change in child salivary cotinine [ Time Frame: 2, 4, 8, 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: 2, 4, 8, and 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): NCT01935713
|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|