Clinical trial NCT02500238: Comparison of Smoking and Vaping in Families
Official title: Comparison of Smoking and Vaping in Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2015-07-16
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In order to be included in the study, parents must: 1) be a legal guardian of a child between the ages of 6-17 (if caregiver has more \> 1 child between 6-17 years; 2) be aged 18-65 years; and 3) be fluent in English. Additionally, the child must reside in the same home as the caregiver.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of lung function
timeFrame: Day 1
Secondary outcomes:
measure: Assessment of cotinine in saliva
timeFrame: Day 1
measure: Assessment of cotinine in urine
timeFrame: Day 1
measure: Assessment of nicotine in toenail clippings
timeFrame: Day 1
measure: Assessment of cotinine in toenail clippings
timeFrame: Day 1
measure: Assessment of tobacco specific nitrosamine in toenail clippings
timeFrame: Day 1
measure: Assessment of tobacco specific nitrosamine in urine
timeFrame: Day 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Uf Ctsi Crc
state: Florida
city: Oklahoma City
country: United States
facility: OUHSC
state: Oklahoma
Study officials:
affiliation: University of Florida
name: David A Fedele, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: