Comparison of Smoking and Vaping in Families

NCT ID: NCT02500238

Last Updated: 2018-12-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-11-30

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.

Conditions

Smoking

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control

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.

Saliva sample

Intervention Type: OTHER

All participants will provide a saliva sample.

Urine Sample

Intervention Type: OTHER

All participants will provide a urine sample.

Toe nail clippings

Intervention Type: OTHER

All participants will provide toe nail clippings.

Breath carbon monoxide test

Intervention Type: OTHER

All participants will provide breath carbon monoxide tests

Smoking

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.

Saliva sample

Intervention Type: OTHER

All participants will provide a saliva sample.

Urine Sample

Intervention Type: OTHER

All participants will provide a urine sample.

Toe nail clippings

Intervention Type: OTHER

All participants will provide toe nail clippings.

Breath carbon monoxide test

Intervention Type: OTHER

All participants will provide breath carbon monoxide tests

Vaping

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.

Saliva sample

Intervention Type: OTHER

All participants will provide a saliva sample.

Urine Sample

Intervention Type: OTHER

All participants will provide a urine sample.

Toe nail clippings

Intervention Type: OTHER

All participants will provide toe nail clippings.

Breath carbon monoxide test

Intervention Type: OTHER

All participants will provide breath carbon monoxide tests

Interventions

Saliva sample

All participants will provide a saliva sample.

Intervention Type: OTHER

Urine Sample

All participants will provide a urine sample.

Intervention Type: OTHER

Toe nail clippings

All participants will provide toe nail clippings.

Intervention Type: OTHER

Breath carbon monoxide test

All participants will provide breath carbon monoxide tests

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David A Fedele, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Uf Ctsi Crc

Gainesville, Florida, United States

OUHSC

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

OCR14742

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201500475

Identifier Type: -

Identifier Source: org_study_id