Novel Methods to Reduce Children's Secondhand Smoke Exposure II

Study Overview
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Brief Summary
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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.

Official Title
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Novel Methods to Reduce Children's Secondhand Smoke Exposure II

Conditions
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Secondhand Smoke

Intervention / Treatment
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* Drug: Nicotine polacrilex
* Drug: Tobacco lozenge


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Does not meet all of the requirements of inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Counseling<br> | |
| Experimental: Nicotine lozenge<br>Participants will receive nicotine lozenge to use as needed for 12 weeks. | Drug: Nicotine polacrilex<br> <br> |
| Experimental: Tobacco lozenge<br>Participants will receive tobacco lozenge to use as needed for 12 weeks. | Drug: Tobacco lozenge<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child Salivary Cotinine | Child salivary cotinine will be measured to assess the level of secondhand smoke exposure. We will measure the change throughout the study. | 3, 6, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parent and Child Lung Function | We will collect both parent and child spirometry data and compare changes. | 3, 6, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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second hand smoke exposure; children