Comparison of Smoking and Vaping in Families

Smoking Clinical Trial

Official title:

Comparison of Smoking and Vaping in Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500238
• Other study ID #: IRB201500475
• Secondary ID: OCR14742
• Status: Completed
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• Saliva sample
All participants will provide a saliva sample.
• Urine Sample
All participants will provide a urine sample.
• Toe nail clippings
All participants will provide toe nail clippings.
• Breath carbon monoxide test
All participants will provide breath carbon monoxide tests

Locations

Country	Name	City	State
United States	Uf Ctsi Crc	Gainesville	Florida
United States	OUHSC	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of lung function	Child lung function will be measured at the study visit. Forced expiratory volume in the first second will be assessed.	Day 1
Secondary	Assessment of cotinine in saliva	Child saliva samples will be collected at the study visit. Samples will be assessed for cotinine levels.	Day 1
Secondary	Assessment of cotinine in urine	Child urine samples will be collected at the study visit. Samples will be assessed for cotinine levels.	Day 1
Secondary	Assessment of nicotine in toenail clippings	Child toenail samples will collected at the study visit. Samples will be assessed for nicotine levels.	Day 1
Secondary	Assessment of cotinine in toenail clippings	Child toenail samples will be collected at the study visit. Samples will be assessed for cotinine levels.	Day 1
Secondary	Assessment of tobacco specific nitrosamine in toenail clippings	Child toenail samples will be collected at the study visit. Samples will be assessed for NNAL levels.	Day 1
Secondary	Assessment of tobacco specific nitrosamine in urine	Child urine samples will be collected at the study visit. Samples will be assessed for NNAL levels.	Day 1