Smoking is the largest preventable cause of U.S. morbidity and mortality. Although many smokers quit, many relapse and no treatment program reports more than modest success. Nicotine is similar to other addictive drugs in its addictive properties and withdrawal symptoms. We propose a controlled clinical pilot study to determine the feasibility of using the comprehensive Preventive Lifestyles smoking cessation program (comprised of behavior and diet modification, a personalized exercise regimen, nutrition education and nutritional supplementation), as a smoking cessation aid. Study situs is Fred Hutchinson Cancer Research Center. Subjects recruited from the general public will receive a standardized counseling/behavioral modification program with either the Preventive Lifestyles product or an identical-appearing placebo. Primary endpoints are product acceptability and incidence of withdrawal symptoms and side effects at six weeks, determined by questionnaire, and the research team's ability (capability and compatibility) to conduct a randomized trial. The need for program changes also will be determined. The pilot study will include at least forty subjects. Results of this trial will determine the feasibility of performing a long-term (l year) efficacy trial requiring approximately 1200 subjects to satisfy appropriate Type I and Type II error problems.
