Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction

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Moolchan MT, Robinson ML, Ernst M, Cadet JL, Pickworth WB, Heishman SJ, et al. Pediatrics 2005;115:e407-e414

Context Despite the belief that nicotine replacement therapy (NRT) would be beneficial in adolescent smokers, few pharmacologic interventions have been evaluated for the treatment of this population.

Objective To determine the safety and efficacy of the nicotine patch and gum for adolescents who want to quit smoking.

Design Double-blind, double-dummy, randomized, three-arm trial with a nicotine patch (21 mg), nicotine gum (2 and 4 mg), or a placebo patch and gum; all participants received cognitive-behavioral group therapy.

Setting Inner-city, outpatient clinic on the East Coast.

Participants Thirteen- to 17-year-old adolescents who smoked ≥10 cigarettes per day (CPD), scored ≥5 on the Fagerström Test of Nicotine Dependence, and were motivated to quit smoking.

Interventions Twelve weeks of nicotine patch or gum therapy with cognitive-behavioral therapy (CBT), with a follow-up visit at 6 months (3 months after the end of treatment).

Main Outcome Measures Safety was assessed on the basis of adverse event reports for all 3 groups; prolonged abstinence was assessed through self-report and verified with exhaled carbon monoxide (CO) levels of ≤6 ppm; and smoking reduction was measured by CPD and thiocyanate concentrations among trial completers.

Results A total of 120 participants were randomized (72% white, 70% female; age: 15.2 ± 1.33 years; smoking: 18.8 ± 8.56 CPD; Fagerström Test of Nicotine Dependence score: 7.04 ± 1.29) from 1999 to 2003. Participants started smoking at 11.2 ± 1.98 years of age and had been smoking daily for 2.66 ± 1.56 years; 75% had at least one current psychiatric diagnosis. Mean compliance across groups was higher for the patch (mean: 78.4%-82.8%) than for the gum (mean: 38.5%-50.7%). Both the patch and gum were well tolerated, and adverse events were similar to those reported in adult trials. Changes in mean saliva cotinine concentrations throughout treatment were not statistically significant. Intent-to-treat analyses of all randomized participants showed CO-confirmed prolonged abstinence rates of 18% for the active-patch group, 6.5% for the active-gum group, and 2.5% for the placebo group; the difference between the active-patch and placebo arms was statistically significant. There was no significant effect of patch versus gum or gum versus placebo on cessation outcomes. Abstinence rates at the 3-month follow-up assessment were sustained but were not significantly associated with treatment group. Mean smoking rates, but not CO or thiocyanate concentrations, decreased significantly in all three arms but not as a function of treatment group.

Conclusions Nicotine-patch therapy combined with cognitive-behavioral intervention was effective, compared with placebo, for treatment of tobacco dependence among adolescent smokers. Decreases in the numbers of cigarettes smoked appeared to be offset by compensatory smoking. Additional study of nicotine gum, with enhanced instructional support, is needed to assess its efficacy among adolescent smokers.

Comment This important and well-designed study provides evidence for the safety and use of nicotine replacement therapy (NRT), along with group CBT, to help adolescents quit smoking. Moolchan and colleagues conducted one of the only randomized trials with the primary outcome being the safety and efficacy of the nicotine patch and gum on adolescent smoking reduction. The inclusion criteria were appropriately rigorous, as was the sample size calculation that considered the high attrition rates often seen with adolescent smoking cessation trials. Reductions in self-reported smoking were >80% for all groups by the end of the medication phase, with no differences between groups. The clinical implication of using NRT as a harm reduction method for adolescents is unique and important. Not only would adolescents have less carcinogen exposure, using NRT may also increase the chance that they will quit successfully in the future.

The patch and gum were safe and resulted in significant rates of biochemically confirmed smoking abstinence compared with placebo, with the patch having the highest quit rate. Using the gum on a scheduled basis (eg, every 2 hours) rather than “as needed” may have improved the gum group outcome. It's important to note that the authors included subjects with comorbid psychiatric conditions taking prescribed medication; this lends support to the safety and use of NRT in this special population. Behavioral counseling is important for smoking cessation, but the group CBT in this study may not be feasible in an outpatient setting. However, incorporating components of CBT over time is practical and may increase effectiveness. As a result of this study, practitioners should feel comfortable prescribing NRT along with behavioral counseling to adolescents with nicotine addiction.