The Evaluation and Treatment of Tobacco Use Disorder

Combination drug therapy. Combining the nicotine patch with a self-administered form of nicotine (eg, gum, spray, inhaler) is more efficacious than a single NRT.¹⁷ One randomized trial also showed that bupropion combined with the patch was more efficacious than the patch alone but not significantly better than bupropion alone. Combination treatments should be considered for smokers unable to quit because of significant craving or withdrawal despite adequate doses of single agents.

Other recommended pharmacotherapies. The 2000 clinical practice guidelines recommended the use of clonidine hydrochloride and nortriptyline hydrochloride as second-line agents. Controlled studies on both agents are limited,^43-48 and neither agent is approved by the United States Food and Drug Administration for smoking cessation. Clonidine or nortriptyline should only be considered for patients who failed the first-line drugs or are unable to use them because of contraindications. Adverse events are generally more than for first-line agents.

Choice of Treatment

Few data exist on the comparative efficacy of the 5 approved pharmacotherapy aids Table 1. The STEPS (safety, tolerability, efficacy, price, simplicity) approach can be used to guide physicians in the choice of pharmacologic agents. All NRTs are considered generally safe, and adverse effects associated with their use are mild. The NRTs have similar cardiovascular precautions (ie, avoid use in unstable angina and within 1 month of a myocardial infarction), are pregnancy category D (there is evidence of human fetal risk, but use is acceptable if benefits outweigh risks and safer alternatives are unavailable or ineffective), except the gum, which is category C (animal studies have revealed adverse effects on the fetus, but there are no controlled studies in women) and should be used during pregnancy only if nonpharmacologic approaches are unsuccessful. Bupropion is also relatively safe with precaution as discussed earlier. Product-specific characteristics could make some NRTs less suitable for certain patients. For example, the gum is not appropriate for patients with dental or jaw problems and may be difficult to use correctly, since it requires special chewing techniques and high frequency of use. Very humid weather conditions may affect adhesiveness of the patch. The patch should also be avoided in patients with systemic eczema.

The only study that compared the efficacy of various NRTs reported similar results for all 4 NRTs. Although one study reported superior efficacy for bupropion over the patch,⁴⁹ this finding has not been replicated. Bupropion costs slightly less than the NRTs Table 2. Of the NRTs, the patch appears to be the most convenient to use. In one randomized controlled trial,⁵⁰ compliance was highest for the patch (82%) compared with the gum (38%), the spray (15%), and the inhaler (11%). A limitation common to all smoking cessation pharmacologic trials is that participants were volunteers with higher motivation to quit smoking and willing to comply with frequent follow-up contacts required in clinical trials. The effectiveness of these medications in real world settings may be lower than that reported in clinical trials. Also, the placebo arms in these trials typically receive substantially more counseling than what happens in real world settings. These factors combined produce higher quit rates in placebo patients than that found in typical unaided quit attempts. Physicians should consider using an algorithm Figure 1 to assist them in approach to and treatment of smokers.

Follow-up

Relapse is quite common among smokers trying to quit. On average, it takes 4 to 5 quit attempts before a smoker is successful.⁴ For this reason the last step of the AHRQ recommendations (arrange, ie, make arrangement for follow-up care for smoking cessation), is very important. The follow-up contact should occur within 1 week of patient’s quit date, because the risk of relapse back to smoking is highest during the first few days of abstinence.^51,52 There are considerable data showing that additional follow-up contact beyond initial brief advice significantly increases quit rates.^23,53,54

A variety of follow-up methods have been used in clinical trials, including face-to-face contact with a physician or other health care professional, letters, telephone, and self-help materials. Nurses and other office staff could be trained and designated to perform some or all the follow-up contact.^18,55-57 In a recently published randomized trial,⁵⁸ office nurses were trained to provide telephone follow-up contacts for low-income Medicaid managed care smokers. Abstinence rates at 3 months were 21% and 8% for telephone follow-up and usual care, respectively.

In addition to office-based telephone and printed self-help resources, physicians should be aware of a growing number of free telephone helplines and Internet-based resources Table 3 available for people trying to quit smoking. Patients without personal Internet access should be encouraged to make use of such services available at most public libraries.