Cigarette smoking is a leading cause of death in the United States. Transdermal nicotine systems (TNS) show considerable promise as a means of assisting dependent smokers to quit. However, TNS also suffers important limitations. The current Phase I research will assess the effectiveness of a combination of nicotine reduction faders and TNS in reducing the abruptness of the transition in cotinine intake from smoking to abstinence and in reducing withdrawal symptoms. Subjects (N = 120 total) will be randomly assigned in double blind fashion to either active nicotine reduction faders followed by 11 mg Prostep/R, placebo nicotine reduction filters followed by 11 mg Prostep/R, or placebo nicotine reduction filters followed by 22 mg Prostep/R. Three weeks of filters will be followed by an abbreviated four-week schedule of TNS. It is hypothesized that 11 mg TNS following active faders will be at least as effective as 22 mg TNS following placebo and more effective than 11 mg TNS following placebo in reducing the cotinine transition from filters to TNS and in minimizing withdrawal symptoms. The Phase II research will focus upon long-term abstinence outcomes. If the results are as hypothesized, an effective low cost and widely disseminable self-help smoking cessation method will have been established.
