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Nicotine Gum, 2 and 4 mg, for Nicotine Dependence : A Double-blind Placebo-controlled Trial Within a Behavior Modification Support Program FREE TO VIEW

Natasha Herrera; Roberto Franco; Lorenzo Herrera; Antolin Partidas; Ramon Rolando; Karl Olov Fagerström
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Affiliations: From the Smoking Cessation Clinic, Centro Medico Docente La Trinidad, Caracas, Venezuela,  From the Smoking Cessation Clinic, University of Lund, Lund, and Pharmacia Research Laboratories, Helsingborg, Sweden

Affiliations: From the Smoking Cessation Clinic, Centro Medico Docente La Trinidad, Caracas, Venezuela,  From the Smoking Cessation Clinic, University of Lund, Lund, and Pharmacia Research Laboratories, Helsingborg, Sweden


1995 BY THE AMERICAN COLLEGE OF CHEST PHYSICIANS


Chest. 1995;108(2):447-451. doi:10.1378/chest.108.2.447
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Abstract

The effectiveness of nicotine gum in combination with a behavior modification program was studied. The nicotine dependence of participating smokers (N=322) was assessed. One hundred sixty-eight smokers were labeled as high nicotine dependent and 154 as moderate to low dependent. In a randomized double-blind procedure, the high-dependent smokers were given gum containing 4 mg of nicotine (87) or 2 mg of nicotine (81) and 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 (112) or to regular use, that is starting gum use on the quit day (122). In the high-dependent group, sustained and chemically verified nonsmoking 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 low 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% for those given placebo gum. The differences in success rates were significant at least at the p<0.02% level for all comparisons. Familiarizing with the gum as compared with regular use gave fewer reports of side 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 favorably with those reported from the more recent nicotine patch therapy.


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