Comparison of Smoking and Vaping in Families

Study Overview
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Brief Summary
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Electronic cigarette use may be less harmful than cigarettes in adults, however, limited data exists examining passive electronic cigarette exposure and child health outcomes. The current study seeks to compare health-related outcomes among youth who reside with non-smokers, cigarette smokers, and electronic cigarette users. The investigators propose to conduct a small pilot study with 30 youth, ages 6-17 and a caregiver. Three groups of 10 parent-child dyads will be recruited: 1) control group: parents who are non-smokers/non-vapers, 2) smoking group: parents who are exclusive cigarette smokers, and 3) vaping group: parents who are exclusively ECIG users. Groups will be compared across the following variables: child lung function and biomarkers of nicotine.

Detailed Description
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The current study seeks to compare health-related outcomes among youth who reside with non-smokers, cigarette smokers, and electronic cigarette users. Control Group: will consist of participants ages 6 - 17 who live in a home with adults who do not smoke. A brief breathing test will verify a non-smoker and/or are not around a certain amount of smoke in the environment (live with a smoker). The participant will be asked to complete a series of brief questionnaires that asks about basic demographic information, medical history, and that asks about their smoking history. The participant's will also be asked to complete two 5 minute breathing tests, provide a sample of saliva, a urine sample, and have their toe nails clipped. Vaping Group: will consist of participants ages 6 -17 who live in a home with adults who currently use electronic cigarettes. A brief breathing test will verify a non-tobacco smoker and/or are not around a certain amount of smoke in the environment (live with a tobacco smoker). The participant will be asked to complete a series of brief questionnaires that asks about basic demographic information, smoking or vaping history and patterns of use, and medical history. The participant will be asked to complete two 5 minute breathing tests, provide a sample of saliva, a urine sample, and have their toe nails clipped. Smoking Group: will consist of participants ages 6 - 17 who live in a home with adults who currently smoke cigarettes. Participants will then be asked to complete a series of brief questionnaires that asks about basic demographic information, smoking or vaping history and patterns of use, and medical history. The participant will also be asked to complete two 5 minute breathing tests, provide a sample of saliva, a urine sample, and have their toe nails clipped.

Official Title
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Comparison of Smoking and Vaping in Families

Conditions
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Smoking

Intervention / Treatment
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* Other: Saliva sample
* Other: Urine Sample
* Other: Toe nail clippings
* Other: Breath carbon monoxide test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the control group the caregiver must self-report: never smoking or not smoking for at least the past 12 months; that no one living in the home is a current smoker or has smoked in the home for the past 6 months; and have a breath carbon monoxide reading of ≤ 6ppm. For the smoking group caregivers must: smoke at least 10 cigarettes per day for the past year; indicate that they smoke in the car or home ≥ 3 times per week; and do not use non-cigarette tobacco (e.g., cigars, chewing tobacco). For the vaping group caregivers must: exclusively use EC for the past 3 months (no cigarette or other tobacco use); and no one living in the home is a current tobacco smoker or has smoked in the home for the past 6 months; and have a breath carbon monoxide reading of ≤ 6ppm.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>This group will provide 2 breath carbon monoxide (reading of ≤ 6 parts per million) and a saliva sample, urine sample, and toe nail clippings will be taken from this group. | Other: Saliva sample<br>* All participants will provide a saliva sample.<br>Other: Urine Sample<br>* All participants will provide a urine sample.<br>Other: Toe nail clippings<br>* All participants will provide toe nail clippings.<br>Other: Breath carbon monoxide test<br>* All participants will provide breath carbon monoxide tests<br>|
| Smoking<br>This group will provide 1 breath carbon monoxide test (reading of ≤ 6 parts per million) and a saliva sample, urine sample, and toe nail clippings. | Other: Saliva sample<br>* All participants will provide a saliva sample.<br>Other: Urine Sample<br>* All participants will provide a urine sample.<br>Other: Toe nail clippings<br>* All participants will provide toe nail clippings.<br>Other: Breath carbon monoxide test<br>* All participants will provide breath carbon monoxide tests<br>|
| Vaping<br>This group will provide 2 breath carbon monoxide test (reading of ≤ 6 parts per million) and a saliva sample, urine sample, and toe nail clippings. | Other: Saliva sample<br>* All participants will provide a saliva sample.<br>Other: Urine Sample<br>* All participants will provide a urine sample.<br>Other: Toe nail clippings<br>* All participants will provide toe nail clippings.<br>Other: Breath carbon monoxide test<br>* All participants will provide breath carbon monoxide tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of lung function | Child lung function will be measured at the study visit. Forced expiratory volume in the first second will be assessed. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of cotinine in saliva | Child saliva samples will be collected at the study visit. Samples will be assessed for cotinine levels. | Day 1 | 
| Assessment of cotinine in urine | Child urine samples will be collected at the study visit. Samples will be assessed for cotinine levels. | Day 1 | 
| Assessment of nicotine in toenail clippings | Child toenail samples will collected at the study visit. Samples will be assessed for nicotine levels. | Day 1 | 
| Assessment of cotinine in toenail clippings | Child toenail samples will be collected at the study visit. Samples will be assessed for cotinine levels. | Day 1 | 
| Assessment of tobacco specific nitrosamine in toenail clippings | Child toenail samples will be collected at the study visit. Samples will be assessed for NNAL levels. | Day 1 | 
| Assessment of tobacco specific nitrosamine in urine | Child urine samples will be collected at the study visit. Samples will be assessed for NNAL levels. | Day 1 |