University of Michigan
Department of Pediatrics
Evidence-Based Pediatrics Web Site

Question

• 16 yr old presents to clinic with history of smoking 1 pack per day for over a year and desires to quit smoking. She would like to try the nicotine patch. What is the efficacy of the nicotine patch for smoking cessation in adolescents?

Clinical Bottom Lines

1. In double blind, double dummy, randomized controlled trial of nicotine patch, nicotine gum and placebo, patch shown to result in statistically significant smoking cessation when compared to gum and placebo. Abstinence rate of 18% in active patch group, 6.5% in active gum group and 2.5% in placebo group. Comparison between patch and placebo resulted in OR of 8.36 (95% CI, p=.043, NNT=6).¹
2. Nicotine patch is safe when used in doses as high as 21mg in adolescents even if they continue to smoke.
3. Nicotine gum not very useful in assisting with smoking cessation.

Summary of Key Evidence

1. 13-17 yr olds recruited via advertisements on TV, in schools, and churches from 1999-2003.¹
2. 1347 initially responded, 329 eligible, 159 actually presented, 120 randomized for treatment, with 53 actually completing the study.
3. Included if smoking >10 CPD, scoring high on Fagerstrom Test of Nicotine Dependence, motivated to quit, and with consent of parent or legal guardian. Patients excluded if with major health problem, pregnant, acute psychiatric illness.
4. Patients randomly distributed to 3 groups: 21mg nicotine patch and placebo gum, placebo patch and 4mg nicotine gum, placebo patch and placebo gum for total of 12 weeks
5. Weekly follow up first 6 weeks with self report of cigarettes smoked per day, measurement of exhaled CO and blood and saliva nicotine, thiocyanate and cotinine levels and 45min of cognitive behavioral therapy. Bi-weekly follow up for second 6 weeks with same parameters obtained and continued CBT
6. Final f/u at 3months after study finish with same parameters measured and self report of abstinence or cigarettes smoked per day
7. 80% reduction in cigarettes smoked per day in all three treatment groups with abstinence as noted above.
8. Increased side effects noted with nicotine patch and gum over placebo, but none lethal.

Additional Comments

• Reduction in number of cigarettes smoked per day rates based on self-report from patients despite no statistically significant change in CO levels is concerning for inaccurate reporting of cigarette use.
• Study limitations include small sample size, poor follow up given only 53 of 120 finished study, and results primarily based upon self reported smoking status.
• There are not very many resources available for providing support or CBT for adolescents interested in smoking cessation.

Citation

1. Moolchan ET, Robinson ML, Ernst M, et al. Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction. Pediatrics 2005;115;407-14.

CAT Author: Sana Ahmed, MD

CAT Appraisers: James Gurney, PhD

Date appraised: May 23, 2007