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Clinical Trials/NCT01056588
NCT01056588
Completed
N/A

Predictors of Smoking Outcomes During Treatment Programs

Nationwide Children's Hospital1 site in 1 country126 target enrollmentFebruary 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cigarette Smoking
Sponsor
Nationwide Children's Hospital
Enrollment
126
Locations
1
Primary Endpoint
The primary outcome for this research will be smoking treatment outcomes (reductions or abstinence) compared across the treatment- and control-condition arms.
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The primary objective of this research is to evaluate the effectiveness of this type of smoking cessation program by comparing a treatment group with a control group.

A secondary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens participating in a quit-smoking program.

Hypothesis 1. A greater proportion of the participants in the treatment condition will be verified as abstinent from smoking during the course of treatment than participants of the control condition.

Hypothesis 2. 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

In response to the need for treatments appropriate for adolescent smokers, this research (utilizing a two-group randomized-control design, n = 63 per group) will evaluate the effectiveness and efficacy of a new and innovative Internet-based contingency-management (CM) program for smoking abstinence with adolescent smokers. This program lasts for 42 days and involves a 21 day abstinence phase. For the treatment condition, participants are reinforced for breath samples that verify abstinence from smoking three times per day; however, for the control condition, participants are reinforced for timely breath samples regardless of abstinence status. Because this CM program is Internet based it can be completed from home, which stands to be more viable as a treatment option for adolescent smokers than other treatments requiring frequent trips to a clinical facility. From preliminary work with adult and adolescent smokers, it is expected this treatment program will be highly effective in creating favorable changes in adolescent smoking behavior. This research will also involve eight monthly post-treatment follow-up sessions to determine long-term consistencies or changes in smoking behavior. A secondary goal of this research is to explore pre-treatment assessments of different dimensions of impulsive behavior as predictors of treatment outcome. These behavioral assessments will provide highly detailed information about the specific behavioral styles of adolescent smokers who are unable to effectively change their smoking behavior during treatment. This information should provide new points of emphasis for treatment-program modifications to improve these programs to be more effective for adolescents most challenged in their efforts to quit or reduce smoking.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
January 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brady Reynolds

Associate Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • Ages of 13-19
  • Have a breath CO level of at least 10ppm
  • Smoke at least 2 cigarettes per day
  • Live in Columbus, OH area

Exclusion Criteria

  • Adolescents must be English-speaking

Outcomes

Primary Outcomes

The primary outcome for this research will be smoking treatment outcomes (reductions or abstinence) compared across the treatment- and control-condition arms.

Time Frame: approximately 9.5 months

Secondary Outcomes

  • The secondary outcome for this research will involve the use of pre-treatment assessments of impulsive behavior as predictors of treatment response at the end of the treatment for both conditions and also during followup.(approximately 9.5 months)

Study Sites (1)

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