Cigarette smoking is the leading preventable cause of disease and death for all Americans. African Americans (AAs) continue to have a high prevalence of smoking, up to 50 percent among the urban poor. Enabling them to quit smoking is a national health priority. In the United States, smoking cessation efforts have focused primarily on heavy smokers and excluded light smokers (smoke s10 cigarettes per day). However, up to 50 percent of African American (AA) smokers are light smokers. Despite smoking fewer cigarettes a day, AAs extract more nicotine per cigarette smoked, and have higher tobacco- related morbidity and mortality. Using a nicotine inhaler may help smokers quit; however, it has not been studied among light smokers. Because light smokers constitute a large proportion of AA smokers, it is critical that cessation interventions, including pharmacological aids and counseling strategies, be developed to include AA light smokers. The primary aim of this study is to assess the efficacy of nicotine inhaler and motivational interviewing for smoking cessation among inner-city AA light smokers. This randomized, placebo-controlled study will be conducted at a community-based clinic, Swope Parkway Health Center, in Kansas City, Missouri. The primary outcome of the study is biochemically-verified 7-day point prevalence abstinence from cigarette at 6 months. Secondary outcomes include: 1) 7-day point prevalence abstinence at 12 weeks and 1 year; 2) continuous abstinence at 12 weeks, 6 months, and 1 year; 3) change in the number of cigarettes smoked; 4) differences among groups in the effect of MI counseling based on participants' level of motivation; and, 5) differences among groups in the effect of the inhaler based on number of cigarettes smoked. This study will use a factorial design (2X2) in which 756 (189 in each arm) light smokers will be randomly assigned to one of four study arms: Tx1, Tx2, Tx3, and Tx4. Participants in Tx1 will receive placebo inhaler plus four health education sessions; Tx2 will receive placebo inhaler plus four MI counseling sessions; Tx3 will receive active nicotine inhaler plus four health education sessions; and, Tx4 will receive active nicotine inhaler plus four MI counseling sessions. Inhaler treatment (active or placebo) will be for 12 weeks. Recruitment and retention will be enhanced by use of monetary reimbursement for transportation and for completing study assessments, provision of attractive intervention materials, and a community advisory board. Post-intervention focus groups of quitters and non-quitters will assess the project's intervention components. Ultimately, we envision that the intervention, if efficacious, would enhance our understanding of smoking cessation and nicotine dependence, and could be used as a pre-packaged intervention for AA light smokers.
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