Tobacco Dependence
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSmoking 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.
Sponsors
National Cancer Institute (NCI)
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long term smoking cessation using both prolonged and point prevalence abstinence criteria | 24 months |
Countries
United States
Outcome results
None listed