Planning a Change Easily (PACE): A randomized controlled trial for smokers who are not ready to quit

Smoking cessation programs are efficacious and have been validated to assist the 10% to 30% of smokers who are ready to quit in the next 30 days. While the majority of smokers want to quit smoking in the future, only 69% are planning to quit within the next year. Planning a Change Easily (PACE) is a nation-wide, telephone-based comparative effectiveness, randomized controlled trial for smokers not ready to quit (SNRTQ). This project, as well as its intervention components, outcomes, and hypotheses are discussed. This study will compare the effectiveness of four intervention conditions that could potentially help SNRTQ to quit smoking: Brief Advice, Motivational Interviewing, Rate Reduction, and Motivational Interviewing plus Rate Reduction combined. Rate Reduction conditions will include the provision of nicotine replacement therapy in the form of gum. Approximately 840 participants will be recruited and randomized to the four intervention conditions. The main outcomes for this study include self-report prolonged and point prevalence abstinence with biochemical verification of cessation. Secondary outcomes include quit attempts, cost-per-quit, and cost-effectiveness analyses. Informed by evidenced-based interventions, strong clinical guidelines, and economic analysis, PACE has the potential for significant public health impact. Results could readily be disseminated and translated to tobacco quitlines, which are present in all 50 states and are offered free to the public.