Bupropion SR and smoking cessation in actual practice: methods for recruitment, screening, and exclusion for a field trial in a managed-care setting

Abstract

Background Little is known about the effectiveness of bupropion SR for smoking cessation outside the context of clinical efficacy trials, where in-person screening and treatment occur at a higher level than provided in a typical health care system. This article describes the methods for recruitment, screening for exclusions, and resulting sample in a field trial of bupropion SR undertaken in a managed-care setting. Methods A total of 2979 telephone interviews were conducted to screen and identify eligible volunteers using a detailed protocol that allowed for consultation with study physicians when necessary. The volunteers’ primary care physicians were given the option to override their eligibility, and pharmacy databases were used to verify medication reporting. Results A total of 1909 (64%) volunteers were considered eligible for the study. The most common reason for exclusion was use of contraindicated medications (32%), followed by recent use of one of the behavioral cessation programs (14%), brain injury that reduced seizure threshold (14%), current depression (14%), and high levels of alcohol use (13%). Conclusions The methods used in this field trial show that it is possible to enroll subjects in an effectiveness trial that is successful from the standpoint of the consumer, provider, and health care system.