The primary aim of this study is to assess the incremental benefit of adjuvant behavioral therapy with the transdermal nicotine patch (TNP) for smoking cessation in inner-city African Americans. This 4 year randomized intervention trial will be conducted at two community-based clinics. The primary outcome of the study is biochemically-verified continuous abstinence from cigarettes at 6 months from the end-of-treatment. Secondary outcomes include 1) continuous, 30-day, and 7-day abstinence at one year; 2) differences among, and within, the three groups in advancing along the stages of change continuum; and, 3) cost-effectiveness, as measured by cost-per-successful quitter. This two arm study has one comparison group (c) and one intervention group (Tx1). Group 1 (Comparison = C) will receive usual care, typical of a primary care setting, consisting of brief physician advice and a previously developed culturally-sensitive smoking cessation guide written at the sixth grade reading level (Pathways to Freedom). Group 2 (Boosted Self-Help = Tx1) will receive the same as C with the addition of a culturally-sensitive smoking cessation video (Kick-It!), a baseline individual counseling session, and four stage-based booster phone calls, the goals of which are, to encourage quitting, to increase use of the written and audiovisual materials, and to maintain compliance with TNP. There will be six data collection points: 1) at screening, in person; 2) at baseline, in person; 3) at 6 weeks, in person; 4) at 10 weeks (the end-of-treatment), by telephone; 5) at six months, in person; and, 6) at one year, by telephone. Recruitment and retention of subjects will be enhanced by phone and mailed reminders to pick up remaining TNP at six weeks and to return for the six month visit, by a monetary stipend for return at the sixth month visit, and by home visits at six months for no shows. The intervention groups have been designed so that efficacy, durability, and generalizabilty, can be accurately measured and assessed. This randomized controlled trial will use the patient as the unit of randomization and analysis. We project that 400 smokers for C, and 400 for Tx1, a total of 800 patients, will be required at baseline to detect proposed treatment effects for the primary outcome with a power of 80%. Ultimately, we envision that the interventions, if efficacious, could be used as a pre-packaged intervention and be distributed at settings such as churches and social service agencies.
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