These products include nicotine gum, transdermal nicotine, nicotine inhaler, and nicotine nasal spray. The only nonnicotine medication for smoking cessation that is approved by the FDA is bupropion sustained release (SR), or Zyban. This product, originally marketed as an antidepressant, was initially observed to reduce smoking among depressed patients (Ferry et al., 1992). Subsequent clinical trials among smokers showed that this agent is an effective smoking cessation aid.
In the United States, the FDA has approved these medications only as cigarette smoking cessation aids. Currently, these pharmaceuticals are not recommended solely for the purposes of reducing the number of cigarettes or as a step toward achieving abstinence, to treat withdrawal symptoms or craving in situations when smoking is not allowed, or for quitting tobacco products other than cigarettes. In addition, the safety and efficacy of these medications in pregnant smokers have not been determined, and the use of medications to aid smoking cessation in this population has been delegated to the discretion of the physician.
It is important to note that the pharmaceutical industry was required to provide ancillary behavioral treatments along with the medications to assist the smoker in quitting. These behavioral treatments range from general self-help materials, to tailored self-help materials, to telephone counseling. The FDA imposed this requirement because cigarette smoking not only is considered a physical addiction to nicotine but also is associated with behavioral components. Research results indeed show that behavioral treatment will augment the success rates of medications alone, and the more intensive the treatment is, the greater is the rate of abstinence (Fiore et al., 2000). However, the use of medications with minimal or no behavioral treatments still outperforms placebo treatment, as demonstrated by the efficacy of over-the-counter nicotine medications (Fiore et al., 2000). Therefore, harm reduction approaches with medications may have to be considered in the context of ancillary behavioral treatments.
The concept of the use of nicotine replacements was first fully described by Ferno (1973). The principles behind nicotine replacements are to (1) provide cigarette smokers a sufficient amount of nicotine to allay some of the withdrawal symptoms experienced shortly after tobacco abstinence; (2) to permit progressive reduction of the level of nicotine exposure, leading to eventual ease of totally withdrawing from nicotine products; and (3) to reduce the abuse potential of nicotine due to the slower rate of nicotine absorption. The validity of these principles and mechanisms has been demonstrated by a number of studies (see Henningfield