Individualizing Nicotine Replacement Therapy for the Treatment of Tobacco Dependence: A Randomized Trial

Ann Intern Med. 2004 Mar 16;140(6):426-33. doi: 10.7326/0003-4819-140-6-200403160-00009.


Background: Despite the well-documented efficacy and different pharmacokinetic and pharmacodynamic properties of different forms of nicotine replacement therapy, empirical data are insufficient to guide practitioners in selecting a particular form of treatment for individual patients with tobacco dependence.

Objective: To evaluate the comparative efficacy of transdermal nicotine and nicotine nasal spray and identify predictors of treatment outcome.

Design: Randomized, open-label clinical trial with a 6-month follow-up period.

Setting: 2 university-based smoking cessation research programs.

Participants: 299 treatment-seeking smokers who were followed for 6 months after the target quit date.

Intervention: Behavioral group counseling and 8 weeks of therapy with nicotine nasal spray or transdermal nicotine.

Measurements: Demographic characteristics, smoking history, depression symptoms, and body mass index were measured at baseline. Smoking practices were biochemically verified at the end of treatment and at 6 months after the target quit date.

Results: Abstinence rates for the transdermal nicotine and nicotine nasal spray groups were not significantly different at 6-month follow-up (15.0% vs. 12.2%, respectively; P > 0.2). Interactions in abstinence rates for subgroups of smokers were statistically significant (P < 0.05). Smokers who had low to moderate dependence levels, were not obese, and were white achieved higher abstinence rates with transdermal nicotine, whereas smokers who were highly dependent, obese, or members of minority groups achieved higher abstinence rates with nasal spray.

Limitations: The subgroup findings need confirmation in additional large studies before they are routinely applied.

Conclusions: Ethnicity, weight, and level of nicotine dependence may help identify smokers who have greater or lesser abstinence rates with either transdermal or nasal spray nicotine.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Administration, Cutaneous
  • Administration, Intranasal
  • Adult
  • Behavior Therapy
  • Cotinine / therapeutic use
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Nicotine / administration & dosage*
  • Obesity / complications
  • Smoking Cessation / methods*
  • Socioeconomic Factors
  • Tobacco Use Disorder / complications
  • Tobacco Use Disorder / drug therapy*
  • Tobacco Use Disorder / ethnology
  • Treatment Outcome


  • Nicotine
  • Cotinine