Matching Nicotine Replacement Treatment to Particular Smokers

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The summary below is from the full report titled "Individualizing Nicotine Replacement Therapy for the Treatment of Tobacco Dependence. A Randomized Trial." It is in the 16 March 2004 issue of Annals of Internal Medicine (volume 140, pages 426-433). The authors are C. Lerman, V. Kaufmann, M. Rukstalis, F. Patterson, K. Perkins, J. Audrain-McGovern, and N. Benowitz.

What is the problem and what is known about it so far?

Smoking substantially increases risks for several diseases, including lung cancer. Quitting smoking can be very difficult. To help smokers quit, doctors routinely recommend nicotine replacement therapy. There are several different forms of nicotine replacement therapy, including chewing gums, nasal sprays, and patches placed on the skin (transdermal patches). Even when people use these therapies, 70% to 80% of them return to smoking within 6 to 12 months. Researchers wonder whether some people might respond better to certain forms of nicotine treatment and achieve higher quit rates.

Why did the researchers do this particular study?

To find out if smokers and, if so, which smokers, achieve higher quit rates with nasal spray than they do with transdermal patches.

Who was studied?

299 healthy smokers who wanted to quit at 2 university-based research programs in the United States.

How was the study done?

Study participants included adult smokers who smoked more than 9 cigarettes daily for the previous year. All wanted to quit. They had responded to advertisements or had been referred by their doctors for free treatment to quit smoking. All received 7 counseling sessions that focused on managing smoking triggers, preventing relapse, and managing stress. In addition, they were randomly assigned to receive either nicotine nasal spray or transdermal nicotine. Both forms of nicotine were given in gradual decreasing doses for 8 weeks. Interviewers who did not know which participants received which therapy called them at the end of treatment and again 6 months later and asked them if they were still smoking. The researchers then compared the quit rates between the groups of smokers given nasal spray and transdermal nicotine. In addition, the researchers tried to determine whether people with certain characteristics responded better to nasal spray or transdermal nicotine.

What did the researchers find?

At 6 months, 12% of persons given nasal spray and 15% of those given transdermal nicotine were not smoking. Smokers who started out highly dependent on nicotine, obese smokers, and members of minority groups achieved higher quit rates with nasal spray. Smokers with lesser initial nicotine dependence, nonobese smokers, and white smokers achieved higher quit rates with transdermal nicotine.

What were the limitations of the study?

The participants may not be representative of all smokers. Results may differ in the general population. Findings in subgroups of participants in randomized trials are always less certain than findings based on comparing the 2 groups of participants that were randomly assigned to one intervention or another. The subgroup findings need confirmation in additional large studies involving smokers with multiple different characteristics.

What are the implications of the study?

Choosing forms of nicotine replacement treatment on the basis of characteristics of smokers is an intriguing but not yet proven effective idea.