Prolonged Smoking Cessation Using Prescriptive Step Care

Principal Investigator: Robert C. Klesges, Ph.D.

Mayo Clinic

Abstract:

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 who quit 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:

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.

A summary of the design and time line of the study is presented below.

	Baseline	6-month Follow-up	12-month Follow-up	24-month Follow-up
Condition 1: Standard of care	Brief physician Rx	Assess smoking status	Assess smoking status	Assess smoking status
Condition 2: Behavioral step care	Brief physician Rx; one session behavioral Rx	Brief physician Rx and four-session behavioral Rx	Brief physician Rx and 6-session behavioral Rx, including Motivational interviewing	Assess smoking status
Condition 3: Pharmacological step care	Brief physician Rx; 6 weeks of patch	Brief physician Rx; Zyban pharmacologic Rx	Brief physician Rx; Nicotine patch and nicotine gum pharmacologic Rx	Assess smoking status
Condition 4: Combined pharmacologic/ behavioral step care	Brief physician Rx; one session behavioral Rx; 6 weeks of patch	Brief physician Rx; four-session behavioral Rx; Zyban pharmacologic Rx	Brief physician Rx; 6-session behavioral/ Motivational interviewing Rx; Nicotine patch and nicotine gum pharmacologic Rx	Assess smoking status