The purpose of this study is to test the safety, tolerability, compliance and efficacy of two different forms of nicotine replacement therapy (NRT) (nicotine transdermal patch and nicotine gum) in a nicotine-dependent adolescent population. Tobacco-dependent adolescents experience the same degree and types of withdrawal symptoms as adult tobacco- dependent individuals and relapse for the same reasons as adults. Nicotine replacement therapy with the patch and the gum has been shown to be effective in assisting adult smoking cessation. To date, only one open-label study has been reported for NRT in adolescents. The patch caused a similar number, type and intensity of side-effects in adolescents as in adults, none of which were serious or precluded the continuation of treatment. The nicotine patch produced similar blood cotinine (principal metabolite of nicotine) levels in adolescents and adults. The efficacy, safety and low abuse liability of nicotine gum in adults has been well documented, however its effects in adolescents have not been studied. Smoking has a significant adverse effect on survival: life shortening amounts to three years for light smokers, five for moderate smokers and eight for heavy smokers, compared with those who never smoked. It, therefore, becomes critical to ascertain to what extent NRT could effect a reduction in adolescent smoking, thereby reducing tobacco-related morbidity and mortality (434,000 per year in the U.S.) at this early stage of addiction. This 6-month outpatient study will investigate the safety, tolerability, compliance and efficacy, in adolescents, of two different forms of NRT, the transdermal patch (21 mg) and the nicotine gum (2 mg and 4 mg), in combination with counseling/ group support. Three groups of 18 adolescents (Group A: Active Patch/Support; Group B: Active Gum/Support; Group C: Support only) will be enrolled in this double-blind, double-dummy treatment study. Data on the safety (adverse side-effects), compliance and acceptability of the patch vs. the gum for the treatment of adolescent nicotine dependence will be obtained. Data on withdrawal symptomatology, self-reported smoking behavior, expired air carbon monoxide (CO), saliva cotinine and thiocyanate levels, will provide information on the efficacy of both forms of NRT in this age group. This body of information will be of great value in developing effective treatment modalities for adolescent nicotine dependence. This pilot study will also establish the basis for future efficacy studies of medications for smoking cessation/reduction in adolescent populations. We have completed this study and are now reporting on the findings, still awaiting some of the assay results. Of 120 participants randomized (72% Caucasian, 70% female, age 15.2 ? 1.33 years, smoked 18.8 ? 8.56 CPD, FTND score 7.04 ? 1.29), 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 percent used 78.4-82.8%) than for the gum (mean percent used 38.5 -50.7%). Both patch and gum use were well tolerated, adverse events were similar to those reported in adult trials. Changes in mean saliva cotinine concentration throughout treatment were not statistically significant. Intent-to-treat analyses of all randomized participants showed CO-confirmed prolonged abstinence rates of 18% for active patch, 6.5% for active gum, 2.5% for the placebo group; the difference between the active patch and placebo arms was statistically significant (two-tailed Fisher?s exact test p=0.043). There was no significant effect of patch versus gum or gum versus placebo on cessation outcome. Point prevalence abstinence at 3 months follow-up was not significantly associated with treatment group. Mean smoking rates, but not CO or thiocyanate concentrations, decreased significantly in all 3 arms, but not as a function of treatment group. In conclusion, nicotine patch therapy combined with cognitive behavioral intervention was effective compared to placebo for treatment of tobacco dependence in adolescent smokers. Decreases in number of cigarettes smoked appeared to be offset by compensatory smoking. Further study of the nicotine gum with enhanced instructional support is needed to assess its efficacy in adolescent smokers.
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