NICOTINE PATCHES IN SMOKING CESSATION - A RANDOMIZED TRIAL AMONG OVER-THE-COUNTER CUSTOMERS IN DENMARK

The authors examined the effect of 24-hour nicotine patches in smoking cessation among over-the-counter customers in Denmark, based on a ran domized double-blind placebo-controlled trial. Participants were conse cutive customers to whom nicotine patches were offered as the only tre atment. Forty-two pharmacies in the areas of Aarhus and Copenhagen in Denmark participated in the trial, and 522 customers who smoked 10 or more cigarettes per day were randomized to either nicotine patches or placebo from January to March 1994. Customers with chronic diseases an d pregnant or breastfeeding women were excluded from the trial. Twenty -four-hour patches were offered free of charge during a 3-month period . Those smoking 20 or more cigarettes per day started on a dose of 21- mg/day patches. Customers who smoked less started on patches of 14 mg/ day; and for all of the participants, the dose was gradually reduced t o 7-mg/day patches during the study period. Smoking behavior and compl iance were recorded by means of self-administered questionnaires and t elephone interviews. Smoking status was recorded in intervals of 4 wee ks, which was fixed to be a treatment period, and 26 weeks after inclu sion. There was a significant increase in smoking cessation rates afte r 8 weeks of follow-up but only among smokers who started on 21-mg/day patches. There was a marked placebo effect at each time of contact du ring the trial, especially in those smoking fewer than 20 cigarettes p er day. Although the noncompliance rate was high overall due to discon tinuation in the use of patches by relapsed smokers, noncompliance amo ng successful quitters was low. More side effects were seen in the nic otine group than in the placebo group, but none of the reported side e ffects ware serious. It appears that regular healthy smokers who were customers of nonprescribed nicotine patches and who received 21-mg/day nicotine patches benefited from the active treatment (44.1% stopped s moking after 4 weeks), but almost as many stopped smoking in the place bo group (37.3% after 4 weeks). No significant differences in smoking cessation rates were seen among smokers who started with the low-dose nicotine or placebo patches.