title: Nicotine gum, 2 and 4 mg, for nicotine dependence. A double-blind placebo-controlled trial within a behavior modification support program.
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.
authors.affiliation: Smoking Cessation Clinic, Centro Medico Docente La Trinidad, Caracas, Venezuela.
authors.forename: N
authors.initials: N
authors.lastname: Herrera
authors.forename: R
authors.initials: R
authors.lastname: Franco
authors.forename: L
authors.initials: L
authors.lastname: Herrera
authors.forename: A
authors.initials: A
authors.lastname: Partidas
authors.forename: R
authors.initials: R
authors.lastname: Rolando
authors.forename: K O
authors.initials: KO
authors.lastname: Fagerström
mesh_terms: D000328:Adult; D001521:Behavior Therapy / Q000379:methods; D002638:Chewing Gum; D003131:Combined Modality Therapy; D003367:Cotinine / Q000032:analysis; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects; D012463:Saliva / Q000737:chemistry; D016540:Smoking Cessation / Q000379:methods; D019966:Substance-Related Disorders / Q000378:metabolism / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002638:Chewing Gum; D009538:Nicotine; D003367:Cotinine