Long-Term Nicotine Replacement Therapy | Clinical Trial


The goal of the trial was to evaluate different treatment durations of nicotine replacement therapy among smokers.

Contribution to the Literature: This trial failed to show that prolonged nicotine replacement therapy (>8 weeks) led to higher rates of smoking cessation.

Study Design

Smokers were randomized to nicotine replacement therapy (transdermal nicotine patch 21 mg) for 8 weeks (standard therapy; n = 180) versus 24 weeks (extended therapy; n = 173) versus 52 weeks (maintenance therapy; n = 172). In addition, all participants received 12 standardized behavioral counseling sessions. 

Inclusion criteria:

  • Smokers (≥10 cigarettes per day) at least 18 years of age who were willing to stop smoking
  • Total number of enrollees: 525
  • Duration of follow-up: 52 weeks
  • Mean patient age: 46 years
  • Percentage female: 51%

Exclusion criteria:

  • Psychotic or bipolar disorder
  • Suicidality
  • Unable to communicate in English
  • Pregnant or lactating women

Principal Findings:

At 24 weeks, 21.7% of the standard therapy group was abstinent within the previous 7 days (CO2 confirmed) versus 27.2% of the extended/maintenance therapy group (p = 0.17).

Secondary outcomes:

  • At 24 weeks: 9.4% of the standard therapy group was continuously abstinent (self-report) versus 11.3% of the extended/maintenance therapy group (p = 0.79)
  • Severe adverse effects at 30 weeks: 4.9% with standard therapy versus 2.6% with extended therapy, versus 6.8% with maintenance therapy


Among smokers, >8 weeks of nicotine replacement therapy did not significantly increase rates of smoking cessation compared with 8 weeks. However, long-term nicotine replacement therapy appeared to be safe.


Schnoll RA, Goelz PA, Veluz-Wilkins A, et al. Long-term nicotine replacement therapy: a randomized clinical trial. JAMA Intern Med 2015;Feb 23:[Epub ahead of print].

Clinical Topics: Prevention, Smoking

Keywords: Nicotine, Smoking, Smoking Cessation, Tobacco Use Cessation Products, Counseling, Primary Prevention

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