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Related Experiment Video

Updated: Apr 17, 2026

Spectral Confocal Imaging of Fluorescently tagged Nicotinic Receptors in Knock-in Mice with Chronic Nicotine Administration
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Long-term nicotine replacement therapy: a randomized clinical trial.

Robert A Schnoll1, Patricia M Goelz2, Anna Veluz-Wilkins3

  • 1Department of Psychiatry, University of Pennsylvania, Philadelphia.

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|February 24, 2015
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Summary

Nicotine patch treatment up to 24 weeks improves smoking abstinence rates. Longer treatment durations (52 weeks) did not show additional benefits, but long-term nicotine patch use remains safe. Keywords: nicotine patch, smoking cessation, tobacco abstinence.

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Area of Science:

  • Addiction Medicine
  • Clinical Pharmacology
  • Public Health

Background:

  • The US FDA approved extended nicotine patch labeling based on 24-week efficacy data.
  • Few studies have investigated the benefits of nicotine patch use beyond 24 weeks.

Purpose of the Study:

  • To compare the efficacy of 8 (standard), 24 (extended), and 52 (maintenance) weeks of nicotine patch treatment for promoting tobacco abstinence.

Main Methods:

  • A randomized clinical trial involving 525 smokers receiving behavioral counseling.
  • Participants were randomized to 8, 24, or 52 weeks of nicotine patch treatment.
  • Primary outcome was 7-day point prevalence abstinence assessed at 6 and 12 months, confirmed by carbon monoxide breath levels.

Main Results:

  • Abstinence rates at 24 weeks were significantly higher in the 24-week and 52-week groups compared to the 8-week group (OR, 1.70).
  • Extended treatment (24 weeks) led to longer abstinence duration, fewer cigarettes smoked if not abstinent, and more abstinent days.
  • No significant differences in abstinence rates were observed at 52 weeks across all treatment arms. Lower adherence to the nicotine patch regimen was noted in the 52-week group.

Conclusions:

  • Nicotine patch treatment up to 24 weeks is effective for promoting tobacco abstinence.
  • While safe for long-term use, treatment beyond 24 weeks does not offer additional therapeutic benefits for most smokers.
  • Findings support the safety of extended nicotine patch use but do not support efficacy beyond 24 weeks.