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Comparison of Smoking and Vaping in Families

Comparison of Smoking and Vaping in Families

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02500238
Enrollment
44
Registered
2015-07-16
Start date
2015-11-30
Completion date
2016-11-30
Last updated
2018-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

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.

Interventions

OTHERSaliva sample

All participants will provide a saliva sample.

OTHERUrine Sample

All participants will provide a urine sample.

OTHERToe nail clippings

All participants will provide toe nail clippings.

OTHERBreath carbon monoxide test

All participants will provide breath carbon monoxide tests

Sponsors

University of Oklahoma
CollaboratorOTHER
University of Florida
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of lung functionDay 1Child lung function will be measured at the study visit. Forced expiratory volume in the first second will be assessed.

Secondary

MeasureTime frameDescription
Assessment of cotinine in urineDay 1Child urine samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Assessment of nicotine in toenail clippingsDay 1Child toenail samples will collected at the study visit. Samples will be assessed for nicotine levels.
Assessment of cotinine in salivaDay 1Child saliva samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Assessment of tobacco specific nitrosamine in toenail clippingsDay 1Child toenail samples will be collected at the study visit. Samples will be assessed for NNAL levels.
Assessment of tobacco specific nitrosamine in urineDay 1Child urine samples will be collected at the study visit. Samples will be assessed for NNAL levels.
Assessment of cotinine in toenail clippingsDay 1Child toenail samples will be collected at the study visit. Samples will be assessed for cotinine levels.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026