NICOTINE GUM, 2 AND 4 MG, FOR NICOTINE DEPENDENCE - A DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL WITHIN A BEHAVIOR-MODIFICATION SUPPORT PROGRAM

The effectiveness ofnicotine gum in combination with a behavior modifi cation program was studied. The nicotine dependence of participating s mokers (N=322) was assessed. One hundred sixty-eight smokers were labe led as high nicotine dependent and 154 as moderate to low dependent. I n a randomized double-blind procedure, the high-dependent smokers were given gum containing 4 mg of nicotine (87) or 2 mg of nicotine (81) a nd the smokers with medium or low dependence were given gum containing 2 mg (76) or a placebo gum (78). The smokers were also randomized to familiarizing themselves with the medication a week before quit day (1 12) or to regular use, that is starting gum use on the quit day (122). In the high-dependent group, sustained and chemically verified nonsmo king rates at 6 weeks, 1 year, and 2 years were, respectively, 60%, 39 %, and 34% in the subjects given the 4-mg dose compared with 41%, 16%, and 16% for those using the 2-mg dose, In the group with medium or lo w dependence, the success rates at the same time periods were 70%, 49% , and 39% for the subjects given the 2-mg dose and 38%, 22%, and 17% f or those given placebo gum. The differences in success rates were sign ificant at least at the p<0.02% level for all comparisons. Familiarizi ng with the gum as compared with regular use gave fewer reports of sid e effects, 15% vs 34%, p<0,001. A trend toward better success rates at 6 weeks, although not statistically significant, was observed for the familiarization group, 61% vs 52%. The study shows that high nicotine -dependent smokers need higher doses of nicotine replacement, in this case the 4-mg dose rather than the 2-mg dose, whereas 2 mg is superior to placebo among less dependent smokers, These results compare favora bly with those reported from the more recent nicotine patch therapy.