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Prolonged Smoking Cessation Using Prescription Step Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00170079
First Posted: September 15, 2005
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert C. Klesges, University of Tennessee
September 12, 2005
September 15, 2005
December 2, 2014
April 2005
January 2011   (Final data collection date for primary outcome measure)
Long term smoking cessation using both prolonged and point prevalence abstinence criteria [ Time Frame: 24 months ]
Long term smoking cessation using both prolonged and point prevalance abstinence criteria
Complete list of historical versions of study NCT00170079 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Prolonged Smoking Cessation Using Prescription Step Care
Prolonged Smoking Cessation Using Prescription Step Care

Smoking is the number one preventable cause of morbidity and mortality in this nation. Unfortunately, more than 50% of those who quit following a smoking cessation intervention typically relapse within two weeks, with approximately 80% relapsing within six months. Therefore, tobacco use can be conceptualized as a chronic condition. As with many chronic medical problems, tobacco use interventions may benefit from a step care approach to treatment.

A total of 400 adult smokers will be enrolled in the study. Participants will be randomly assigned to one of two treatment conditions consisting of: 1) A State of the Art Smoking Cessation Intervention + Recycling or: 2) A State of the Art Smoking Cessation Intervention + Step Care. Long term smoking cessation will be assessed by self-report, exhaled carbon monoxide levels, and salivary cotinine. The primary endpoint of the study will be smoking abstinence rates at two-year follow-up. It is predicted that long-term cessation rates will be significantly higher in the step care condition than for those assigned to the recycling group.

A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of step care. Despite a high degree of interest in applying the step care model to smoking cessation (Abrams et al., 1996; Hughes, 1994), little empirical work has been conducted utilizing this treatment approach. The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims:

Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings;

Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and

Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tobacco Dependence
Behavioral: Smoking Cessation Intervention

A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of "step care." The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims:

Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings;

Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and

Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition.

Experimental: Step care vs. regular care
Participants were randomized either to (1) Step care intervention, where smokers who failed to quit or who relapsed received increasingly intensive smoking cessation interventions; vs. (2) Regular care, where smokers who failed to quit or who relapsed received repeated intervention.
Intervention: Behavioral: Smoking Cessation Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
June 2011
January 2011   (Final data collection date for primary outcome measure)
Cigarette smokers who are 18 years of age or older, who self-report smoking at least 10 cigarettes each day, and who are willing to accept random assignment are eligible to participate. Potential participants must agree to commit to the study for at least 24 months, be screened and agree to potentially participate in more intensive interventions to help them stop smoking, and agree to not seek other treatment for smoking cessation during the treatment phase of the study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00170079
1730-04
R01CA106667-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Robert C. Klesges, University of Tennessee
University of Tennessee
National Cancer Institute (NCI)
Principal Investigator: Robert C. Klesges, Ph.D. Mayo Clinic
University of Tennessee
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP