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Prolonged Smoking Cessation Using Prescription Step Care

18 Years
Open (Enrolling)
Tobacco Dependence

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Trial Information

Prolonged Smoking Cessation Using Prescription Step Care

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Long term smoking cessation using both prolonged and point prevalence abstinence criteria

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Robert C. Klesges, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

April 2005

Completion Date:

June 2011

Related Keywords:

  • Tobacco Dependence
  • Tobacco Use Disorder



Mayo Clinic Rochester, Minnesota  55905
University of Tennessee Memphis, Tennessee  38163