Real-world efficacy of prescription and over-the-counter nicotine replacement therapy

Addiction. 2002 May;97(5):505-16. doi: 10.1046/j.1360-0443.2002.00141.x.


Aims: To assess smoking cessation rates achieved with nicotine gum and patch in simulated over-the-counter (OTC) and actual prescription (Rx) settings.

Design: Separate open-label studies with gum and patch in OTC and Rx settings.

Participants: There were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669.

Interventions: All smokers received active nicotine replacement. In the OTC setting, smokers self-selected doses of nicotine gum (2 or 4 mg Nicorette) or patch (21, 14 or 7 mg NicoDerm CQ). No intervention was provided. In the Rx setting, smokers were prescribed gum or patch by their physician.

Measurements: Biochemically verified continuous smoking abstinence was assessed at 6 weeks (28-day abstinence) and 6 months.

Findings: OTC success rates were consistently higher than Rx rates: differences were significant at 6 weeks for both patch [OR = 1.45 (1.05-1.98)] and gum [OR 2.92 (1.58-5.40)], and remained significant at 6 months for patch [OR = 3.63: (1.74-7.61)] but not gum [OR = 1.37: (0.73-2.58)]. Among OTC gum users. 16.1% were abstinent at 6 weeks and 8.4% at 6 months. For Rx gum users, abstinence rates were 7.7% at 6 weeks and 7.7% at 6 months. With OTC patch, 19.0% were abstinent at 6 weeks and 9.2% at 6 months. With Rx patch. abstinence rates were 16.0% at 6 weeks and 3.0% at 6 months.

Conclusions: Smoking cessation rates achieved with nicotine gum and patch under OTC conditions were as good as those under real-world prescribing conditions.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Drug Prescriptions*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nicotine / administration & dosage*
  • Nonprescription Drugs*
  • Smoking Cessation / methods*
  • Tobacco Use Disorder / rehabilitation


  • Nonprescription Drugs
  • Nicotine