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
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|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.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
Inclusion Criteria: In order to be included in the study, participants must:
- be the primary caregiver(defined as a person who spends the most time with the child and spends a minimum of 4 hours per day in the presence of the child) of a child between the ages of 3-11 (if caregiver has more > 1 child between 3-11 years, we will include the youngest)
- smoke at least 10 cigarettes per day for the past year
- indicate that they smoke around their child or in the car or home at least one time per week]
- have no intention of quitting smoking in the next 12-weeks
- aged 18-65 years
- be fluent in English
- have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension)
- not currently pregnant, planning to become pregnant, or breastfeeding
- do not use non-cigarette tobacco (cigars, chewing tobacco)
- have no prior use of any potential reduced exposure product
- have no major psychiatric impairment, including psychosis, suicidality, and/or any current alcohol/drug abuse or dependence
- Does not meet all of the requirements of inclusion criteria
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|
|Responsible Party:||University of Oklahoma|
|Other Study ID Numbers:||
|First Posted:||September 5, 2013 Key Record Dates|
|Last Update Posted:||May 4, 2017|
|Last Verified:||May 2017|
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action