Predictors of Teen Smoking-cessation | NCT01141517

Studies
Predictors of Teen Smoking-cessation

NCT01141517

Sponsor

Nationwide Children's Hospital

Status

Completed

Last Update Posted

Jul 22, 2019Actual

Enrollment

147Actual

Phase

Not provided

Conditions

Cigarette Smoking

Interventions

Not-On-Tobacco smoking cessation program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R01DA023087-02	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008Actual

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jun 8, 2010

First Submission Date that Met QC Criteria

Jun 9, 2010

First Posted Date

Jun 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2019

Last Update Posted Date

Jul 22, 2019Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

147Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Not-On-Tobacco smoking cessation program	Behavioral	Adolescent quit-smoking program; Not-On-Tobacco

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	8.5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages of 13 and 19
Enrolled in the NOT program offered by Nationwide Children's Hospital
Currently smoke at least one cigarette per day

Exclusion Criteria:

Adolescents must be English speaking

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brady A Reynolds, PhD	Nationwide Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Condition Browse Module

MeSH Terms

ID	Term
D000073865	Cigarette Smoking

Ancestor Terms

ID	Term
D000073869	Tobacco Smoking
D012907	Smoking
D001519	Behavior
D064424	Tobacco Use

Browse Leaves

Not provided

Browse Branches

Not provided