Evaluation of pharmacologic treatments for smoking cessation
In the last decade there has been an upsurge in the development of new smoking cessation treatments. Although in 1990 the only pharmacologic aid approved by the U.S. Food and Drug administration was nicotine chewing gum, as of the year 2001, four modes of nicotine replacement therapy (NRT) are available (nicotine gum, skin patch, nasal spray, and inhaler) as well as a nonnicotine pharmaceutical, bupropion (Fiore et al. 2000; Hajek et al. 1995). Moreover, there are several other promising treatments at various stages of development, including nicotine antagonist treatment (Covey et al. 2000; Rose et al. 1998; Rose et al. 1994b; Rose et al. 1996b). With a multiplicity of therapeutic techniques and potential combination therapies, it is inevitable that comparisons between the efficacy are sought, and this raises the question of how to compare treatments on a level playing field, using similar methodology and criteria for success. The presentation here reviews some of the most important decisions to be made regarding evaluation of pharmacotherapies for smoking cessation, including sample selection, timing of treatment, outcome measures, and rationale for evaluation of combination treatments. Awareness of the difference in outcome that may result from different decisions made by research teams studying these varied methods, may make it possible to achieve a more accurate evaluation of new treatments and treatment combinations.