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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: Saliva sample; Other: Urine Sample; Other: Toe nail clippings; Other: Breath carbon monoxide test

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.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Uf Ctsi Crc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OUHSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Saliva sample; All participants will provide a saliva sample.; Other: Urine Sample; All participants will provide a urine sample.; Other: Toe nail clippings; All participants will provide toe nail clippings.; Other: Breath carbon monoxide test; 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.	Other: Saliva sample; All participants will provide a saliva sample.; Other: Urine Sample; All participants will provide a urine sample.; Other: Toe nail clippings; All participants will provide toe nail clippings.; Other: Breath carbon monoxide test; 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.	Other: Saliva sample; All participants will provide a saliva sample.; Other: Urine Sample; All participants will provide a urine sample.; Other: Toe nail clippings; All participants will provide toe nail clippings.; Other: Breath carbon monoxide test; All participants will provide breath carbon monoxide tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of cotinine in saliva	Child saliva samples will be collected at the study visit. Samples will be assessed for cotinine levels.	Day 1
Assessment of cotinine in urine	Child urine samples will be collected at the study visit. Samples will be assessed for cotinine levels.	Day 1
Assessment of nicotine in toenail clippings	Child toenail samples will collected at the study visit. Samples will be assessed for nicotine levels.	Day 1
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
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
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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: University of Oklahoma
• Investigators: Principal Investigator: David A Fedele, Ph.D., University of Florida

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gasotransmitters; Carbon Monoxide
• Other Study ID Numbers: IRB201500475; OCR14742 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No