Skip to main content
OpenTrials
Completed

NCT Number: NCT02500238

Comparison of Smoking and Vaping in Families

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uf Ctsi Crc, Gainesville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saliva Sample

Other

All participants will provide a saliva sample.

Urine sample

Other

All participants will provide a urine sample.

Toe nail clippings

Other

All participants will provide toe nail clippings.

Breath carbon monoxide test

Other

All participants will provide breath carbon monoxide tests

Primary outcomes

  1. Assessment of lung function

    Time frame: Day 1

    Child lung function will be measured at the study visit. Forced expiratory volume in the first second will be assessed.

Secondary outcomes

  1. Assessment of cotinine in saliva

    Time frame: Day 1

    Child saliva samples will be collected at the study visit. Samples will be assessed for cotinine levels.

  2. Assessment of cotinine in urine

    Time frame: Day 1

    Child urine samples will be collected at the study visit. Samples will be assessed for cotinine levels.

  3. Assessment of nicotine in toenail clippings

    Time frame: Day 1

    Child toenail samples will collected at the study visit. Samples will be assessed for nicotine levels.

  4. Assessment of cotinine in toenail clippings

    Time frame: Day 1

    Child toenail samples will be collected at the study visit. Samples will be assessed for cotinine levels.

  5. Assessment of tobacco specific nitrosamine in toenail clippings

    Time frame: Day 1

    Child toenail samples will be collected at the study visit. Samples will be assessed for NNAL levels.

  6. Assessment of tobacco specific nitrosamine in urine

    Time frame: Day 1

    Child urine samples will be collected at the study visit. Samples will be assessed for NNAL levels.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • University of Oklahoma

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 16, 2015
Registry last updated
Dec 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.