Contingency Management for Smoking Abstinence With Adolescent Smokers (CM)
|ClinicalTrials.gov Identifier: NCT01056588|
Recruitment Status : Unknown
Verified January 2010 by Nationwide Children's Hospital.
Recruitment status was: Recruiting
First Posted : January 26, 2010
Last Update Posted : June 23, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cigarette Smoking||Behavioral: CO-Contingent Behavioral: Control condition||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Predictors of Smoking Outcomes During Treatment Programs|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
Placebo Comparator: Control Condition
In this condition, participants will receive reinforcement for timely breath samples with no contingency for a specific breath CO level.
Behavioral: Control condition
In this condition, participants will receive monetary reinforcement for timely breath samples with no contingency for a specific breath CO level
Active Comparator: CO-Contingent
In this condition, participants will receive reinforcements contingent on submitting breath samples at CO levels indicating reductions or abstinence from smoking.
In this 42 day condition, participants will receive monetary reinforcements contingent on submitting breath samples at CO levels indicating reductions or abstinence from smoking (4ppm).
- 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 ]
- 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. [ Time Frame: approximately 9.5 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056588
|Contact: Millie Harris, PhDfirstname.lastname@example.org|
|Contact: Ariane Hawkinsemail@example.com|
|United States, Ohio|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Michele Patak, MSW 614-355-3602 firstname.lastname@example.org|
|Principal Investigator:||Brady Reynolds, PhD||Nationwide Children's Hopsital|