Question

• In children and adolescents who smoke cigarettes, are pharmacologic methods for smoking cessation safe and effective

Clinical Bottom Lines

1. No controlled trials exist for either nicotine replacement therapy or bupropion in adolescents.
   
2. Nicotine patch therapy appears to decrease the amount of cigarettes smoked and withdrawal symptoms, but its effect on abstinence rates is unclear.
   
3. Data in adults shows benefit for both nicotine replacement and bupropion.
   

Summary of Key Evidence

Two open-label, non-placebo trials have been published on nicotine patch therapy in adolescents.^1,2 In the larger study, 101 adolescents aged 13-17 underwent 6 weeks of nicotine patch therapy with minimal behavioral therapy:

• Abstinence at 6 weeks was 10.9%; this decreased to 5% at 6 months.
  
• Average number of cigarettes per day decreased during the study from 18.2 to 1.8-2.5, but increased to 9.4 per day by 6 months.
  
• Expired CO levels correlated with reported number of cigarettes smoked; cotinine levels decreased in participants who quit smoking.
  
• Adverse events: URI (44%), HA (43%), N/V (13%), skin irritation (12%), sleep problems (10%).²
  

A systematic review of available adult data (96 placebo-controlled RCT's) showed:

• Abstinence at 1 year of 14% with nicotine patch therapy vs. 8% for placebo (OR 1.74).
  
• One study showed increased abstinence at one year with bupropion (35.5% if combined with patch therapy, 30.3% if used alone vs. 16.4% for patch alone).³
  

Additional Comments

• Data limited to open-label, non-placebo and are subject to several limitations, including lack of suitable comparison group.
  
• Participants needed parental consent and were paid at the completion of the study; may not represent adolescent population as a whole.
  
• Investigators did not comment if all adverse events were considered secondary to therapy.
  
• Adult data may not be applicable to an adolescent population.
  
• Insurance may not cover nicotine replacement therapy; current OTC cost is $60 - $90 for 6 weeks.
  

Citation

1. Hurt RD, Croghan GA, Beede SD, Wolter TD, Croghan IT, Patten CA. Nicotine patch therapy in 101 adolescent smokers: efficacy, withdrawal symptom relief, and carbon monoxide and plasma cotinine levels. Archives of Pediatrics & Adolescent Medicine 2000;154(1):31-7.
   
2. Smith TA, House RF Jr, Croghan IT, Gauvin TR, Colligan RC, Offord KP, Gomez-Dahl LC, Hurt RD. Nicotine patch therapy in adolescent smokers. Pediatrics 1996; 98:659-67.
   
3. Nicotine replacement therapy for smoking cessation. (2002) Cochrane Database of Systematic Reviews. (4):CD000146.
   

CAT Author: Neda N. Yousif, MD

CAT Appraisers: Jonathan E. Fliegel, MD

Date appraised: April 21, 2003