Comparison of Smoking and Vaping in Families

Completed

• Conditions: Smoking
• Interventions: Other: Saliva sample; Other: Urine Sample; Other: Toe nail clippings; Other: Breath carbon monoxide test

• Registration Number: NCT02500238
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Study Start: 2015-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-27
• Last Update Posted: 2018-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

For the control group the caregiver must self-report:

1. never smoking or not smoking for at least the past 12 months;
2. that no one living in the home is a current smoker or has smoked in the home for the past 6 months; and
3. have a breath carbon monoxide reading of ≤ 6ppm.

For the smoking group caregivers must:

1. smoke at least 10 cigarettes per day for the past year;
2. indicate that they smoke in the car or home ≥ 3 times per week; and
3. do not use non-cigarette tobacco (e.g., cigars, chewing tobacco).

For the vaping group caregivers must:

1. exclusively use EC for the past 3 months (no cigarette or other tobacco use); and
2. no one living in the home is a current tobacco smoker or has smoked in the home for the past 6 months; and
3. have a breath carbon monoxide reading of ≤ 6ppm.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Toe nail clippings	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.
Smoking	Toe nail clippings	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.
Vaping	Saliva sample	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.
Control	Urine Sample	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.
Control	Saliva sample	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.
Smoking	Breath carbon monoxide test	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.
Vaping	Toe nail clippings	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.
Vaping	Breath carbon monoxide test	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.
Control	Breath carbon monoxide test	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.
Smoking	Saliva sample	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.
Smoking	Urine Sample	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.
Vaping	Urine Sample	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.

Primary Outcome Measures

Name	Time	Method
Assessment of lung function	Day 1	Child lung function will be measured at the study visit. Forced expiratory volume in the first second will be assessed.

Secondary Outcome Measures

Name	Time	Method
Assessment of cotinine in saliva	Day 1	Child saliva samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Assessment of cotinine in urine	Day 1	Child urine samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Assessment of nicotine in toenail clippings	Day 1	Child toenail samples will collected at the study visit. Samples will be assessed for nicotine levels.
Assessment of tobacco specific nitrosamine in toenail clippings	Day 1	Child toenail samples will be collected at the study visit. Samples will be assessed for NNAL levels.
Assessment of cotinine in toenail clippings	Day 1	Child toenail samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Assessment of tobacco specific nitrosamine in urine	Day 1	Child urine samples will be collected at the study visit. Samples will be assessed for NNAL levels.

Trial Locations

Locations (2)

Uf Ctsi Crc; 🇺🇸 Gainesville, Florida, United States

OUHSC; 🇺🇸 Oklahoma City, Oklahoma, United States