Level 2 [mid-level] evidence


Cigarette smoking is a leading cause of preventable morbidity and mortality. Approximately 20% of adults in the United States smoke cigarettes, and although 69% of smokers report a desire to quit, 4% to 7% are successful each year. Nicotine replacement therapy with transdermal nicotine patches is considered a first-line medication option for the treatment of tobacco use.

Although transdermal nicotine replacement significantly increases the likelihood of smoking cessation compared with placebo, the six-month abstinence rates are usually about 20% with treatment (Cochrane Database Syst Rev. 2012;[11]:CD000146; Addiction. 2008;103[4]:557).

Extending the duration of treatment from the standard eight weeks to 24 weeks was associated with an increased rate of abstinence at 24 weeks, but no significant differences in abstinence at 52 weeks (Ann Intern Med. 20102;152[3]:144), suggesting that extended treatment may increase the duration of smoking abstinence, but only temporarily.

A recent randomized trial attempted to determine the effect of even longer use by comparing nicotine patch treatment for eight weeks vs. 24 weeks vs. 52 weeks in 525 adult smokers (mean age, 46 years) interested in quitting. All included patients who smoked 10 or more cigarettes per day and received patches containing 21-mg nicotine plus smoking cessation counseling (JAMA Intern Med. 2015;1;175[4]:504).


Sixty-seven percent of patients completed the assessment at 24 weeks, and 60% completed the assessment at 52 weeks, but all randomized patients were included in the analysis. Seven-day point-prevalence abstinence rates were confirmed using breath carbon monoxide levels at weeks 8, 24, and 52. At week 24, seven-day point-prevalence abstinence was 21.7% with eight weeks of treatment vs. 27.2% with extended treatment (24-week and 52-week treatment groups combined).

Compared with eight-week standard therapy, extended therapy was associated with a longer duration of abstinence before relapse (mean of 89 days vs. 72 days, P < 0.001), more abstinence days (mean of 80.5 days vs. 68.2 days, P = 0.02), and fewer cigarettes per day on nonabstinent days (mean 5.8 cigarettes vs. 6.4 cigarettes, P = 0.02).

At week 52, there were no significant differences in the prevalence abstinence, duration of abstinence before relapse, or abstinence days comparing eight- or 24-week treatment to 52-week treatment, but treatment for 52 weeks was associated with fewer cigarettes per day on nonabstinent days (mean of 5.4 cigarettes vs. 7.5 cigarettes, P = 0.01). There were no significant differences in adverse events among groups. In a secondary analysis comparing eight-week treatment vs. 24-week treatment, 24-week treatment was associated with significantly increased abstinence rates at 24 weeks, but not at 52 weeks.


The results of this study suggest that nicotine replacement therapy with a transdermal nicotine patch may be safe for 52 weeks of use, but it may not be more effective than 24 weeks of treatment for increasing smoking abstinence rates. Although there were no significant differences in abstinence rates at 24 weeks comparing eight-week treatment to both extended therapy groups, there was a significant difference in the abstinence rate comparing 24 weeks vs. eight weeks at this time point.

These results suggest that it is safe for patients to use nicotine patches for up to one year, although any benefit beyond six months remains unproven. Nicotine replacement therapy should be tailored to individual patients for maximum effectiveness.



Alan Ehrlich, MD, is a deputy editor for DynaMed, in Ipswich, Mass., and assistant clinical professor in Family Medicine, University of Massachusetts Medical School in Worcester.

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