Nicotine Patch Therapy in Adolescent Smokers

Abstract

Objective. To evaluate the safety, tolerance, and efficacy of 24-hour nicotine patch therapy in adolescent smokers who were trying to stop smoking. Design. Nonrandomized, open-label, 6-month clinical trial. Setting. Five public high schools in the Rochester, MN, area. Subjects. Twenty-two adolescent smokers, aged 13 through 17 years, with current smoking rate of 20 or more cigarettes per day (cpd). Intervention. Daily nicotine patch therapy for 8 weeks (22 mg/d for 6 weeks followed by 11 mg/d for 2 weeks). Weekly individual behavioral counseling and group support continued for 8 weeks with follow up visits at 3 and 6 months and a mailed survey at 1 year. Main Outcome Measures. Self-reported smoking abstinence verified by expired air carbon monoxide of 8 ppm or less, nicotine withdrawal symptoms, adverse experiences, and blood cotinine levels. Results. Subjects had a mean ± SD smoking rate of 23.3 ± 5.0 (range, 20 to 35) cpd at study entry and 2.6 ± 1.6 years of smoking; the mean age was 15.9 ± 1.2 (range 13 through 17) years, and 68% were girls. Of the 22 participants, 19 (86%) completed patch therapy, 3 (14%) had biochemically validated smoking cessation at week 8, and 1 continued to be smoke free at 3 and 6 months after patch initiation. There was a significant decrease from baseline in the mean nicotine withdrawal scores for days 4 and 7 of week 1 and the mean for weeks 2 through 8. Skin reactions were the most common adverse event. As the worst skin reactions, 55% had erythema only, 5% had erythema and edema, and 9% had erythema and vesicles, whereas 32% had no skin reactions. Other reported adverse events were headaches (41%), nausea and vomiting (41%), tiredness (41%), dizziness (27%), and arm pain (23%). None of these were considered serious, life threatening, or led to the discontinuation of patch therapy. In adults with comparable smoking rates, we found that the adolescents had lower blood cotinine levels. Those smoking 20 to 25 cpd had cotinine levels of 146 ± 84 (adolescents) vs 260 ± 98 (adults) ng/ml, and those smoking 26 to 35 cpd had levels of 169 ± 73 vs 276 ± 110 ng/ml, respectively. Conclusion. Nicotine patch therapy seems safe in adolescent smokers. Placebo-controlled trials are needed to establish the efficacy of nicotine patch therapy in adolescents.

Smoking cessation: Progress, priorities, and prospectus.

“…This coupled with evidence that adolescent regular smokers are similar to adult smokers in terms of reasons for smoking, difficulty quitting, and other criteria for tobacco dependence (Hurt et al, 2000) has led to efforts to treat these smokers with NRT. Yet, despite evidence of safety, tolerability, and decreased withdrawal symptoms among adolescents treated with the nicotine patch, efficacy has not been demonstrated (Hurt et al, 2000; T. A. Smith et al, 1996).…”

Do adolescent smokers experience withdrawal effects when deprived of nicotine?

“…To date, the two open-label studies of nicotine replacement for smoking cessation in adolescents have shown minimal effects (Hurt et al, 2000; Smith et al, 1996). Our findings offer a partial explanation for the lack of efficacy of nicotine replacement observed in those studies.…”

“…Third, we examined, in controlled fashion, the impact of NRT on the development of symptoms associated with nicotine deprivation. Only two published studies have reported on the effects of the nicotine patch in adolescent smokers, and neither study included a placebo control group (Hurt et al, 2000; Smith et al, 1996). If adolescent smokers experience withdrawal symptoms when deprived of nicotine and NRT can alleviate these effects, then the case favoring nicotine dependence as one of the controlling factors in the smoking behavior of adolescents is made that much stronger.…”

Randomized Clinical Trial of the Efficacy of Bupropion Combined With Nicotine Patch in the Treatment of Adolescent Smokers.

“…Two open label studies have examined nicotine patch treatment (NP) for adolescent smokers. In the first report (Smith et al, 1996), 14% were smoke free at the end of treatment, with 5% remaining smoke free at 6-month follow-up. In the second study, point prevalence abstinence was 11% at 6 weeks and 5% at 26 weeks (Hurt et al, 2000).…”