TRANSDERMAL NICOTINE IN SMOKING CESSATION AND INVOLVEMENT OF NONSPECIFIC INFLUENCES

The efficacy of a nicotine transdermal therapeutic system (TTS) (avail able size 10, 20 and 30 cm 2; nicotine delivery rate = 0.7 mg/cm 2/24 h) as an aid for smoking cessation, was evaluated in a randomized, sin gle-blind, placebo-controlled, monocenter study using 160 heavy-smoker s (>20 cigarettes/day), male and female, who were divided into two mat ched parallel groups. The nicotine replacement treatment lasted for 3 months and was carried out according to the manufacturers recommendati ons. Abstinence was defined as smoking no cigarette during the last we ek of each month and COHb-levels less-than-or-equal-to 1.2%. Efficacy was assessed using abstinence rates, withdrawal symptoms and cigarette consumption. Although at the commencement of the study all subjects e xpressed a high motivation to stop smoking, about a third were lost to follow-up at 4 weeks. This was attributed mainly to the lack of couns elling and group dynamics. The greatest effect on smoking cessation an d cigarette consumption was attributable to a non-specific aspect of t reatment, i. e. the motivation to stop smoking on application of the f irst patch. On an intention-to-treat basis (all subjects), abstinence rates were 24% and 18% after 1 month, 24% and 14% after 2 months and 1 4% and 6% after 3 months for the nicotine-TTS and placebo-TTS, respect ively. Nicotine-TTS was at least twice as effective as placebo in main taining nicotine abstinence. The superiority of the nicotine-TTS was s upported by the trend to a higher craving-for-cigarettes score and sig nificantly higher blood COHb and cigarette consumption in the non-abst ainers treated with placebo.