Contingency Management for Smoking Abstinence With Adolescent Smokers

Cigarette Smoking Clinical Trial

— CM  

Official title:

Predictors of Smoking Outcomes During Treatment Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056588
• Other study ID #: IRB09-00399
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: January 2015

Study information

• Verified date: July 2019
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• CO-Contingent
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).
• Control condition
In this condition, participants will receive monetary reinforcement for timely breath samples with no contingency for a specific breath CO level

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome for this research will be smoking treatment outcomes (reductions or abstinence) compared across the treatment- and control-condition arms.		approximately 9.5 months
Secondary	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