Grant Number:	5R01CA106667-04 Interpret this number
Primary Investigator:	Klesges, Robert
Organization:	University Of Tennessee Health Sci Ctr
Project Title:	Prolonged Smoking Cessation Using Prescription Step Care
Fiscal Year:	2006

DESCRIPTION (provided by applicant): This application is in response to RFA #OB-03-003 titled "Maintenance of long term behavioral change. Smoking is the number one preventable cause of morbidity and mortality in this nation (CDC, 2002; McGinnis & Foege, 1993). Unfortunately, while interest in quitting smoking is very high, the relapse rates of smoking rival that of other addictive behaviors, with 58% of those quitting relapsing within 2 weeks (Garvey et al., 1992; Gulliver et al., 1995; Ward et al., 1997) and up to 80% within six months (Gulliver et al., 1995, Hunt et al., 1971, Hunt and Bespalec, 1974; Zhu et al., 1996). As a result, the most effective smoking cessation programs typically achieve long-term (e.g., one year) cessation rates of only 25-30% (Fiore et al., 2000) and rarely exceed 35-40% (Fiore et al., 1992, 1994; Hughes, 1991, 1996). This recalcitrance has led to the conceptualization of tobacco use as a chronic condition requiring repeated intervention (Fiore et al., 2000). 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, and, to our knowledge, no study has evaluated the impact of a step care approach for both the behavioral and pharmacological components of a comprehensive smoking cessation program. The purpose of the present proposal 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: (1) To enroll approximately 800 adult cigarette smokers recruited from primary care settings; (2) To randomize these participants to: 1) normal standard of care, 2) a step care behavioral intervention, 3) a step care pharmacologic intervention, or 4) a combined behavioral/pharmacologic step care intervention; and (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 conditions, with the highest cessation rate in the combined behavioral/pharmacologic step care group.