Comparison of Smoking and Vaping in Families

NCT02500238 | Completed

• 2 other identifiers: IRB201500475OCR14742
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessment of cotinine in saliva

  Day 1

• Assessment of cotinine in urine

  Day 1

• Assessment of nicotine in toenail clippings

  Day 1

• Assessment of cotinine in toenail clippings

  Day 1

• Assessment of tobacco specific nitrosamine in toenail clippings

  Day 1

Study Arms (3)

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; Other: Urine Sample; Other: Toe nail clippings; Other: Breath carbon monoxide test

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; Other: Urine Sample; Other: Toe nail clippings; Other: Breath carbon monoxide test

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; Other: Urine Sample; Other: Toe nail clippings; Other: Breath carbon monoxide test

Interventions

Saliva sample OTHER

All participants will provide a saliva sample.

Control; Smoking; Vaping

Urine Sample OTHER

All participants will provide a urine sample.

Control; Smoking; Vaping

Toe nail clippings OTHER

All participants will provide toe nail clippings.

Control; Smoking; Vaping

Breath carbon monoxide test OTHER

All participants will provide breath carbon monoxide tests

Control; Smoking; Vaping

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• For the control group the caregiver must self-report:
• never smoking or not smoking for at least the past 12 months;
• that no one living in the home is a current smoker or has smoked in the home for the past 6 months; and
• have a breath carbon monoxide reading of ≤ 6ppm.
• For the smoking group caregivers must:
• smoke at least 10 cigarettes per day for the past year;
• indicate that they smoke in the car or home ≥ 3 times per week; and
• do not use non-cigarette tobacco (e.g., cigars, chewing tobacco).
• For the vaping group caregivers must:
• exclusively use EC for the past 3 months (no cigarette or other tobacco use); and
• no one living in the home is a current tobacco smoker or has smoked in the home for the past 6 months; and
• have a breath carbon monoxide reading of ≤ 6ppm.

Sponsors & Collaborators

• University of Florida: lead
• University of Oklahoma: collaborator

Study Sites (2)

Uf Ctsi Crc

Gainesville, Florida, 32610, United States

Location

OUHSC

Oklahoma City, Oklahoma, 73104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva, urine, and toenail clippings

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• David A Fedele, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 16, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 28, 2018

Record last verified: 2018-12

Locations

US (2)