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Comparison of Smoking and Vaping in Families

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University of Florida

Status

Completed

Conditions

Smoking

Treatments

Other: Saliva sample
Other: Urine Sample
Other: Breath carbon monoxide test
Other: Toe nail clippings

Study type

Observational

Funder types

Other

Identifiers

NCT02500238
OCR14742 (Other Identifier)
IRB201500475

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

6 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

44 participants in 3 patient groups

Control
Description:
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.
Treatment:
Other: Breath carbon monoxide test
Other: Urine Sample
Other: Toe nail clippings
Other: Saliva sample
Smoking
Description:
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.
Treatment:
Other: Breath carbon monoxide test
Other: Urine Sample
Other: Toe nail clippings
Other: Saliva sample
Vaping
Description:
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.
Treatment:
Other: Breath carbon monoxide test
Other: Urine Sample
Other: Toe nail clippings
Other: Saliva sample

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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