title: 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.
  
  
  METHODS
  Nonrandomized, open-label, 6-month clinical trial.
  
  
  METHODS
  Five public high schools in the Rochester, MN, area.
  
  
  METHODS
  Twenty-two adolescent smokers, aged 13 through 17 years, with current smoking rate of 20 or more cigarettes per day (cpd).
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Nicotine patch therapy seems safe in adolescent smokers. Placebo-controlled trials are needed to establish the efficacy of nicotine patch therapy in adolescents.
authors.affiliation: Mayo Medical School, Rochester, Minnesota, USA.
authors.forename: T A
authors.initials: TA
authors.lastname: Smith
authors.forename: R F
authors.initials: RF
authors.lastname: House
authors.forename: I T
authors.initials: IT
authors.lastname: Croghan
authors.forename: T R
authors.initials: TR
authors.lastname: Gauvin
authors.forename: R C
authors.initials: RC
authors.lastname: Colligan
authors.forename: K P
authors.initials: KP
authors.lastname: Offord
authors.forename: L C
authors.initials: LC
authors.lastname: Gomez-Dahl
authors.forename: R D
authors.initials: RD
authors.lastname: Hurt
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D003367:Cotinine / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008910:Minnesota / Q000453:epidemiology; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects; D012907:Smoking / Q000097:blood / Q000188:drug therapy / Q000453:epidemiology; D016540:Smoking Cessation / Q000379:methods* / Q000706:statistics & numerical data; D013375:Substance Withdrawal Syndrome / Q000097:blood / Q000453:epidemiology / Q000209:etiology; D014505:Urban Population / Q000706:statistics & numerical data
chemical_list: D009538:Nicotine; D003367:Cotinine