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.
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