Cigarette SmokingNOTNCT01141517
Predictors of Teen Smoking-cessation
An observational study of Cigarette Smoking, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The primary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens enrolled in a quit-smoking program. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Not-On-Tobacco smoking cessation program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2014
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study population will be adolescent smokers between the ages of 13-19 recruited from local high-schools (Franklin county; Pike county, and Scioto County in Ohio), shopping malls, and newspaper ads.
Who may be able to join
- Ages of 13 and 19
- Enrolled in the NOT program offered by Nationwide Children's Hospital
- Currently smoke at least one cigarette per day
Who cannot join
- Adolescents must be English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Predictors of Smoking Cessation Among Teen Smokers
The primary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens enrolled in a quit-smoking program.
It is hypothesized that teens who do not successfully stop smoking (or who drop out of the treatment program) will be more impulsive (from measures taken just prior to treatment) than those who do successfully stop or significantly reduce rate of smoking.
- Conditions
- Cigarette Smoking
- Being tested
- Not-On-Tobacco smoking cessation program
- Keywords
- adolescent quit-smoking program.
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not-On-Tobacco smoking cessation programBehavioural
Adolescent quit-smoking program; Not-On-Tobacco
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adolescents that quit/reduce smoking and those who do not quit/reduce.
Primary outcomes will be the number of adolescents who quit or reduced smoking and the number of adolescents who did not quit or reduce.
Measured: 8.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJul 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Brady Reynolds, University of Kentucky
- Investigators
- Brady A Reynolds, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141517
- Sponsor's protocol ID
- IRB09-00538
- Other IDs
- 5R01DA023087-02
- Acronym
- NOT
- Status last verified
- Jul 2019
- First submitted
- 8 Jun 2010
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Smoking Cessation Among Teen Smokers
- ClinicalTrials.gov ID
- NCT01141517
- Acronym / sponsor ID
- NOT / IRB09-00538
- Conditions
- Cigarette Smoking
- Keywords
- adolescent quit-smoking program.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2008 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Jun 2010 (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.
The primary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens enrolled in a quit-smoking program.
It is hypothesized that teens who do not successfully stop smoking (or who drop out of the treatment program) will be more impulsive (from measures taken just prior to treatment) than those who do successfully stop or significantly reduce rate of smoking.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population will be adolescent smokers between the ages of 13-19 recruited from local high-schools (Franklin county; Pike county, and Scioto County in Ohio), shopping malls, and newspaper ads.
Key inclusion criteria (3 listed)
- Ages of 13 and 19
- Enrolled in the NOT program offered by Nationwide Children's Hospital
- Currently smoke at least one cigarette per day
Key exclusion criteria (1 listed)
- Adolescents must be English speaking
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 |
|---|---|---|
| Not-On-Tobacco smoking cessation programAdolescent quit-smoking program; Not-On-Tobacco | Behavioural | – |
Primary outcome
Number of adolescents that quit/reduce smoking and those who do not quit/reduce.
Time frame: 8.5 months
Primary outcomes will be the number of adolescents who quit or reduced smoking and the number of adolescents who did not quit or reduce.
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 22 Jul 2019.
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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.
Brady A Reynolds, PhD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking, run by Nationwide Children's Hospital at 1 site 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 3 inclusion and 1 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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of adolescents that quit/reduce smoking and those who do not quit/reduce. (time frame: 8.5 months). 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 22 Jul 2019.