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Contingency Management for Smoking Abstinence With Adolescent Smokers (CM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by Nationwide Children's Hospital
Sponsor:
Collaborator:
University of Florida
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01056588
First received: January 25, 2010
Last updated: June 21, 2011
Last verified: January 2010
  Purpose

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 Intervention
Cigarette Smoking
Behavioral: CO-Contingent
Behavioral: Control condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Predictors of Smoking Outcomes During Treatment Programs

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: February 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).

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.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056588

Contacts
Contact: Millie Harris, PhD 614-722-3021 millie.harris@nationwidechildrens.org
Contact: Ariane Hawkins 614-355-3555 ariane.hawkins@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Michele Patak, MSW    614-355-3602    michele.patak@nationwidechildrens.org   
Sponsors and Collaborators
Nationwide Children's Hospital
University of Florida
Investigators
Principal Investigator: Brady Reynolds, PhD Nationwide Children's Hopsital
  More Information

No publications provided

Responsible Party: Brady Reynolds, PhD Prinicipal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01056588     History of Changes
Other Study ID Numbers: IRB09-00399
Study First Received: January 25, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
adolescent smoking
Contingency management
Quit smoking

ClinicalTrials.gov processed this record on November 23, 2014