Nicotine Faders, Preparation for Nicotine Patches

Cigarette smoking is a leading cause of death in the United States. Transdermal nicotinesystems (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 theeffectiveness of a combination of nicotine reduction faders and TNS in reducing the abruptness of thetransition in continue 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 nicotinereduction faders followed by 11 mg Prostep/R, placebo nicotine reduction filters followed by 11 mgProstep/R, or placebo nicotine reduction filters followed by 22 mg Prostep/R. Three weeks of filters willbe followed by an abbreviated four-week schedule of TNS. It is hypothesized that 11 mg TNS followingactive faders will be at least as effective as 22 mg TNS following placebo and more effective than 11mg TNS following placebo in reducing the cotinine transition from filters to TNS and in minimizingwithdrawal symptoms. The Phase II research will focus upon long-term abstinence outcomes. If theresults are as hypothesized, an effective low cost and widely disseminable self-help smoking cessationmethod will have been established.