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Trial record 19 of 21 for:    E-cigarettes youth

Comparison of Smoking and Vaping in Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500238
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : December 28, 2018
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Smoking 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.

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Comparison of Smoking and Vaping in Families
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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




Primary Outcome Measures :
  1. Assessment of lung function [ Time Frame: Day 1 ]
    Child lung function will be measured at the study visit. Forced expiratory volume in the first second will be assessed.


Secondary Outcome Measures :
  1. Assessment of cotinine in saliva [ Time Frame: Day 1 ]
    Child saliva samples will be collected at the study visit. Samples will be assessed for cotinine levels.

  2. Assessment of cotinine in urine [ Time Frame: Day 1 ]
    Child urine samples will be collected at the study visit. Samples will be assessed for cotinine levels.

  3. Assessment of nicotine in toenail clippings [ Time Frame: Day 1 ]
    Child toenail samples will collected at the study visit. Samples will be assessed for nicotine levels.

  4. Assessment of cotinine in toenail clippings [ Time Frame: Day 1 ]
    Child toenail samples will be collected at the study visit. Samples will be assessed for cotinine levels.

  5. Assessment of tobacco specific nitrosamine in toenail clippings [ Time Frame: Day 1 ]
    Child toenail samples will be collected at the study visit. Samples will be assessed for NNAL levels.

  6. Assessment of tobacco specific nitrosamine in urine [ Time Frame: Day 1 ]
    Child urine samples will be collected at the study visit. Samples will be assessed for NNAL levels.


Biospecimen Retention:   Samples Without DNA
Saliva, urine, and toenail clippings


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500238


Locations
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United States, Florida
Uf Ctsi Crc
Gainesville, Florida, United States, 32610
United States, Oklahoma
OUHSC
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Florida
University of Oklahoma
Investigators
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Principal Investigator: David A Fedele, Ph.D. University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02500238    
Other Study ID Numbers: IRB201500475
OCR14742 ( Other Identifier: University of Florida )
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs