Prolonged Smoking Cessation Using Prescription Step Care
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Tobacco Dependence |
Behavioral: Smoking Cessation Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prolonged Smoking Cessation Using Prescription Step Care |
- Long term smoking cessation using both prolonged and point prevalence abstinence criteria [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | June 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
-
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| Principal Investigator: | Robert C. Klesges, Ph.D. | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Robert C. Klesges, Ph.D.., University of Tennessee |
| ClinicalTrials.gov Identifier: | NCT00170079 History of Changes |
| Other Study ID Numbers: | 1730-04, R01CA106667-01 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013