Tobacco dependence and the nicotine patch. Clinical guidelines for effective use

JAMA. 1992 Nov 18;268(19):2687-94.


Objective: A comprehensive review of transdermal nicotine treatment for tobacco dependence, with recommendations derived from the research literature.

Data sources: English-language clinical trials.

Study selection: Clinical trials using placebo-controlled, double-blind methodology (11 studies) with at least 6 months of follow-up after treatment (eight studies) and biochemical verification of smoking status.

Data synthesis: Nicotine patches produce end-of-treatment smoking cessation rates that range from 18% to 77%; these rates are about twice those of placebo-treated subjects. Nicotine patches produced 6-month abstinence rates of 22% to 42%, while placebo patches produced quit rates of 5% to 28%. Nicotine patches appear to reduce some, but not all, nicotine withdrawal symptoms. For instance, while the patch reduces craving for cigarettes and negative moods, it does not appear to reduce hunger or weight gain. The clinical trials literature suggests that proper adjuvant smoking cessation counseling is crucial in determining successful long-term outcome with the nicotine patch, and suggests that 6 to 8 weeks of patch therapy may be an adequate duration for most patients.

Conclusions: Nicotine patches are an effective aid to tobacco dependence treatment. However, success rates vary greatly across research studies and may be influenced highly by the nature and intensity of adjuvant smoking cessation counseling. More research is needed to identify optimal duration, dosage, and individualization of patch therapy. The impact of nicotine patches (more than 5 million users with $1 billion in sales for 1992) also raises important ethical and public health issues.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Administration, Cutaneous
  • Chewing Gum
  • Clinical Protocols
  • Clinical Trials as Topic
  • Drug Costs
  • Humans
  • Nicotine / administration & dosage*
  • Nicotine / analogs & derivatives
  • Nicotine / pharmacokinetics
  • Nicotine / pharmacology
  • Polymethacrylic Acids
  • Polyvinyls
  • Public Health / economics
  • Smoking / psychology
  • Tobacco Use Cessation Devices
  • Tobacco Use Disorder / therapy*
  • United States


  • Chewing Gum
  • Polymethacrylic Acids
  • Polyvinyls
  • Nicotine