Nicotine Replacement Therapies Do They Work

Although it may seem unbelievable, the first pharmacological agent approved by the Food and Drug Administration (FDA) for use in smoking cessation therapy was nicotine. This is a case of the benefit of fighting fire with fire. Nicotine replacement therapies, such as nicotine gum, patches, nasal sprays, and inhalers, have been approved for use in the United States. They are all designed to relieve withdrawal symptoms. Using them produces less severe physiological alterations than tobacco-based systems, and they generally provide users with lower overall nicotine levels than tobacco. An added benefit is that these forms of nicotine have little abuse potential since they do not produce the pleasurable effects of tobacco products. Nor do they contain the carcinogens and gases associated with tobacco smoke.

The FDA's approval of nicotine gum in 1984 marked the availability (by prescription) of the first nicotine replacement therapy in the United States. In 1996 the FDA approved chewing gum containing nicotine for over-the-counter sales. Chewing nicotine gum interrupts smoking behavior while maintaining nicotine levels in the blood to minimize the effects of withdrawal. Three-month success rates of 76 percent and one-year success rates of 50 percent have been reported.

This approach is most effective when it is accompanied by psychological therapy. Still, it has been found that there is considerable incidence of relapse after gum use is completed. While nicotine gum provides some smokers with control over dose and the ability to relieve cravings, others are unable to tolerate the taste or simply dislike chewing gum. In 1991 and 1992 the FDA approved four transdermal (allowing medication to be absorbed through the skin and into the bloodstream) nicotine patches, two of which became over-the-counter products in 1996. By transferring nicotine through the skin, these patches meet the needs of many tobacco users.

Data from the FDA and the pharmaceutical industry indicate that more than one million individuals have been successfully treated for nicotine addiction using nicotine gum or the transdermal patch. A nicotine nasal spray became available by prescription in 1996, and a nicotine inhaler was introduced in 1998. All of the nicotine replacement products appear to be equally effective. In fact, the combination of over-the-counter availability of these medications and intense media campaigns urging people to quit smoking have produced about a 20 percent increase in the number of people who successfully quit each year.

While doctors await the approval of a nicotine tablet that is dissolved under the tongue, researchers are voicing concern about the long-term physical effects of nicotine replacement therapies. Some smokers use nicotine replacement products for longer periods than is intended for these products. Now that these products have become readily available without a doctor's prescription, there is evidence of undesirable side effects from their long-term use.