SmokingNCT02500238
Comparison of Smoking and Vaping in Families
An observational study of Smoking, run by University of Florida at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Saliva sample, Urine Sample and Toe nail clippings
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2015to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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;
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Uf Ctsi Crc
Gainesville, Florida, 32610
OUHSC
Oklahoma City, Oklahoma, 73104
About this study
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.
Read the 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
- Being tested
- Saliva sample, Urine Sample, Toe nail clippings, Breath carbon monoxide test
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva sampleOther
All participants will provide a saliva sample.
Urine SampleOther
All participants will provide a urine sample.
Toe nail clippingsOther
All participants will provide toe nail clippings.
Breath carbon monoxide testOther
All participants will provide breath carbon monoxide tests
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Saliva sample; Other: Urine Sample; Other: Toe nail clippings; Other: Breath carbon monoxide test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of lung function
Child lung function will be measured at the study visit. Forced expiratory volume in the first second will be assessed.
Measured: Day 1
Secondary outcomes (6)
Assessment of cotinine in saliva
Child saliva samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Measured: Day 1
Assessment of cotinine in urine
Child urine samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Measured: Day 1
Assessment of nicotine in toenail clippings
Child toenail samples will collected at the study visit. Samples will be assessed for nicotine levels.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- David A Fedele, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500238
- Sponsor's protocol ID
- IRB201500475
- Other IDs
- OCR14742
- Status last verified
- Dec 2018
- First submitted
- 8 Jul 2015
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Smoking and Vaping in Families
- ClinicalTrials.gov ID
- NCT02500238
- Acronym / sponsor ID
- IRB201500475
- Conditions
- Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Saliva sample, Other: Urine Sample, Other: Toe nail clippings, Other: Breath carbon monoxide testThis 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. |
| Smoking | – | Other: Saliva sample, Other: Urine Sample, Other: Toe nail clippings, Other: Breath carbon monoxide testThis group will provide 1 breath carbon monoxide test (reading of ≤ 6 parts per million) and a saliva sample, urine sample, and toe nail clippings. |
| Vaping | – | Other: Saliva sample, Other: Urine Sample, Other: Toe nail clippings, Other: Breath carbon monoxide testThis group will provide 2 breath carbon monoxide test (reading of ≤ 6 parts per million) and a saliva sample, urine sample, and toe nail clippings. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (12 listed)
- 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.
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva sampleAll participants will provide a saliva sample. | Other | Control, Smoking, Vaping |
| Urine SampleAll participants will provide a urine sample. | Other | Control, Smoking, Vaping |
| Toe nail clippingsAll participants will provide toe nail clippings. | Other | Control, Smoking, Vaping |
| Breath carbon monoxide testAll participants will provide breath carbon monoxide tests | Other | Control, Smoking, Vaping |
Primary outcome
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.
6 secondary outcomes
Assessment of cotinine in saliva
Time frame: Day 1
Assessment of cotinine in urine
Time frame: Day 1
Assessment of nicotine in toenail clippings
Time frame: Day 1
Assessment of cotinine in toenail clippings
Time frame: Day 1
Assessment of tobacco specific nitrosamine in toenail clippings
Time frame: Day 1
Assessment of tobacco specific nitrosamine in urine
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Fedele, Ph.D. principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of lung function (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.