Adult Smoking Cessation

Nonpharmacological Approaches

Of the many nonpharmacological approaches to smoking cessation, here, behavioral approaches are the most germane. They have undergone the most extensive experimental study, are suitable for office and clinic-based physician interventions, and often are used in combination with pharmacological ap proaches to smoking cessation (Fagerstrom, 1988; Hymowitz, 1999). Multi-component behavioral programs, whether in group, individual, or "self-help" formats, typically include a number of strategies (self-monitoring, stimulus-control procedures, behavioral contracting, alternative behaviors, aversive conditioning, relaxation training, diet and exercise, self-management skill training for relapse prevention, etc.) to motivate smokers, to help them gain control over smoking, and to eliminate smoking systematically from their behavioral repertoire. Once smokers stop smoking, many of the very same behavioral skills that helped them quit smoking are used to help them prevent relapse. Schwartz (1987) reported that 1-year quit rates for multicomponent behavioral group quit-smoking programs average 40%. Initial end-of-treatment quit rates may be considerably higher.

The MRFIT employed diversified behavioral strategies for initial smoking cessation and long-term smoking abstinence (Hughes, Hymowitz, Ockene, Simon, & Vogt, 1981). The reported quit rates for special intervention (SI) men were 43.1% at year 1 and 50% at year 6. These quit rates were significantly superior to those for usual care (UC) participants (13% and 29% at years 1 and 6, respectively). When serum thiocyanate, a breakdown product of hydrogen cyanide, was used as an objective measure of smoking, the quit rate at year 6 for SI participants was reduced to 46% (Hymowitz, 1987).

The Lung Health Study, like the MRFIT, was a large-scale, multicenter, multiyear study in which smokers were exposed to comprehensive behavioral interventions for initial cessation and long-term follow-up (Anthonisen et al., 1994). In addition, SI participants in the Lung Health Study received NRT (nicotine gum, 2 mg). Five-year cross-sectional quit rates, confirmed by expired air carbon monoxide and cotinine, were close to 40% for SI and 20% for UC participants, a highly significant difference.

The MRFIT and the Lung Health Study generated excellent long-term smoking cessation results. Each study featured a multicomponent treatment package for initial smoking cessation, behavioral strategies for active relapse prevention, and comprehensive and sustained approaches to long-term abstinence. While few programs have the resources necessary to provide comparable sustained intervention and follow-up, it is important to incorporate strategies to help successful quitters remain abstinent. Booster sessions, reunions, telephone contact, hot lines, mailings, and the Internet have been tried with varying degrees of success (Hymowitz, 1999).

Nicotine Replacement Therapy

Pharmacotherapies include several forms of NRT and several antidepressants, among which only bupropion SR has been sponsored and approved by the U.S. Food and Drug Administration (FDA; Sweeney, Fant, Fagerstrom, McGovern,

& Henningfield, 2001). Four NRT medications have been approved by the FDA (gum, transdermal patch, nasal spray, and oral inhaler), and a lozenge has recently entered the U.S. market (Shiffman et al., 2002).

Nicotine replacement medications enable the tobacco-dependent person to abstain from tobacco by replacing, at least partially, the nicotine obtained from tobacco. As noted by Sweeney and colleagues (2001), there appear to be at least three major mechanisms by which NRT medications enhance smoking cessation. They (1) reduce either general withdrawal symptoms, or at least prominent ones, enabling people to function normally while they learn to live without a cigarette; (2) reduce the reinforcing effects of tobacco-delivered nicotine; and (3) provide some effects for which the patient previously relied on cigarettes, such as sustaining desirable mood and attention states, and making it easier to handle stressful or boring situations.

The efficacy of NRT products for smoking cessation has been demonstrated in a number of placebo-controlled studies. The gum, transdermal patch, nasal spray, and oral inhaler yield initial and long-term quit rates that more than double those generated by placebo products, and, when combined with behavioral counseling and follow-up, quit rates as high as 40-50 after 1 year have been reported (Fiore et al., 2000). Physicians in a busy office setting, with minimal time available for counseling and follow-up, may generate 1-year quit rates as high as 10% (Hughes, Gust, Keenan, Fenwick, & Healey, 1989), and over-the-counter (OTC) sales of the gum, patch, and lozenge have markedly increased the number of quit-smoking attempts and the number of people using NRT (Shiffman et al., 1997). Although a recent meta-analysis suggests that OTC NRT products yield initial quit rates of the same magnitude as NRT products prescribed by a physician, and twice the quit rate obtained by use of placebo products (Hughes, Shiffman, Callas, & Zhang, 2003), other analyses have questioned the long-term efficacy of OTC NRT products (Pierce & Gilpin, 2002). A survey in California showed that smokers who reported using NRT products to quit smoking were just as likely to relapse after 1 year as those who did not use NRT products (Pierce & Gilpin, 2002; Walsh & Penman, 2000).

In 20 cities that participated in COMMIT, 12.8% of smokers (1 out of 8) used the transdermal nicotine patch, making it the most popular method for stopping smoking (Cummings, Hyland, Ockene, Hymowitz, & Manley, 1997). By comparison, 1 out of 10 smokers used nicotine gum, 1 out of 13 attended a stop-smoking program, 1 out of 16 went to a hypnotist or acupuncturist, and 1 out of 20 used some other commercially available stop-smoking device. Among smokers who made an attempt to quit smoking, the likelihood of successful quitting was more than twice as high among patch users than among nonusers. Among patch users, the highest quit rates were observed among those who used the patch between 1 and 3 months (Cummings et al., 1997).

Compared to nonusers, patch users in COMMIT were more likely to be female and white, to have higher annual incomes, to be more motivated to stop smoking, and to smoke more heavily. Among low-income smokers, nicotine patch use was significantly higher among those who lived in a state where the public insurance program (i.e., Medicaid or MediCal) included the patch as a benefit (Cummings et al., 1997).

Hall, Tunstall, Rugg, Jones, and Benowitz (1985) studied the effects nicotine gum and intensive behavioral treatment. They assigned 122 subjects to (1) intensive behavioral treatment, (2) nicotine gum (2 mg) in a low-contact treatment, or (3) intensive behavioral treatment plus nicotine gum. Gum was available for 6 months from the start of treatment. Subjects met in groups of five to six with experienced psychologists serving as group leaders. The behavioral treatment consisted of aversive smoking, relapse prevention skills training, relaxation training, and written exercises to increase commitment to stopping smoking. Group sessions were held 14 times in an 8-week period. The low-contact treatment had fewer sessions (four times over a 3-week period), paper-and-pencil exercises on reasons for smoking, educational material, and group discussions.

Assessments were held at 0, 2, 12, 26, and 52 weeks. Reports of abstinence were verified by measurement of expired air carbon monoxide and serum thiocyanate, as well as reports from significant others (Hall et al., 1985). Differences between the combined condition and the other two conditions were significant at weeks 3, 12, and 26, but not at week 52. For the combined condition, abstinence rates were 95, 73, 59, and 44% at weeks 3, 12, 26, and 52. Corresponding abstinence rates for the low-contact condition were 81, 58, 47, and 37%. For the behavioral condition, the quit rates were 78, 47, 31, and 28% for weeks 3, 12, 26, and 52, respectively. Smokers with high blood cotinine levels (i.e., highly dependent smokers) were more likely to be helped by nicotine gum than were less dependent smokers (Hall et al., 1985).

With NRT strongly endorsed as an effective therapy for smoking cessation, attention has shifted toward ways of enhancing its effectiveness, particularly for the heavily addicted smokers. Options include increasing the dose of NRT product, extending the duration of use, and combination therapy (e.g., two or more forms of NRT or NRT plus bupropion SR). For heavily addicted smokers, higher doses of nicotine gum (4 mg) led to higher quit rates than 2 mg gum (Herrara et al., 1995). In another study, the 21-mg nicotine patch yielded superior quit rates than 14-mg and placebo patches (Transdermal Nicotine Study Group, 1991). However, no advantage was gained by using a 44-mg patch over a 21-mg patch (Jorenby et al., 1995).

Sims and Fiore (2002) noted that extending the use of pharmacotherapy beyond the recommended time frame may be an effective strategy for helping tobacco users achieve abstinence and for preventing relapse to tobacco use, especially for those who are highly nicotine dependent or concerned about weight gain. Their review suggests that long-term use is not harmful and is an acceptable alternative to continued smoking.

Another approach to enhancing efficacy entails combining an NRT medication that allows for passive nicotine delivery (e.g., transdermal patch) with a form of NRT that permits ad libitum nicotine delivery (e.g., gum, nasal spray, inhaler; Sweeney et al., 2001). The rationale for combining NRT medications is that smokers may need both a slow delivery system to achieve a constant concentration of nicotine to relieve cravings and tobacco withdrawal symptoms, and a faster acting preparation that can be administered on demand for immediate relief of breakthrough cravings and symptoms.

Sweeney and colleagues (2001) identified five published studies that tested the combined use of different nicotine delivery systems. All of the studies used a nicotine patch as one of the study medications, with four of the five studies supplementing nicotine patch treatment with nicotine gum, and the fifth study supplementing patch treatment with nicotine nasal spray. For two of the five studies, the suppression of nicotine withdrawal symptoms was the primary outcome of interest, while the remaining three studies tested the impact of combination therapy on smoking abstinence rates. On the basis of their review, Sweeney and colleagues concluded that there are conditions under which combinations of NRT products provide greater efficacy in relieving withdrawal and fostering cessation than monotherapy. However, the findings are not robust (mean odds ratio = 1.9; Fiore et al., 2000), and additional research is warranted to understand better the magnitude and generality of the benefits of combination therapy.

Bupropion SR

Bupropion SR is the first non-nicotine medication shown to be effective for smoking cessation and approved by the FDA for that use (Fiore et al., 2000). Its mechanism of action may be mediated by its capacity to block neural reuptake of dopamine and/or norepinephrine. Bupropion SR is available exclusively as a prescription medication, with an indication for smoking cessation (Zyban) and an indication for depression (Wellbutrin) (Fiore et al., 2000).

Hurt and colleagues (1997) conducted a double-blind, placebo-controlled trial of bupropion SR for smoking cessation. Six hundred and fifteen subjects were assigned randomly to receive placebo or 100, 150, or 300 mg of bupropion SR per day for 7 weeks. The target quit date was 1 week after the beginning of treatment. Brief counseling was provided at baseline, weekly during treatment, and at 8, 12, 26, and 52 weeks. Self-reported abstinence was confirmed by expired air carbon monoxide (<10 ppm).

At the end of 7 weeks of treatment, the rates of confirmed smoking cessation were 19% for the placebo group and 28.8, 38.6, and 44.2% for the 100-, 150-, and 300-mg bupropion SR groups, respectively. At 1 year, the respective rates were 12.4, 19.6, 22.9, and 23.1% for the placebo, 100-, 150-, and 300-mg bupropion SR groups, respectively. The quit rates for the 150-mg group (p =

.02) and the 300-mg group (p = .01)—but not the 100-mg group (p = .09)— were significantly higher than those for the placebo group (Hurt et al., 1997).

Bupropion SR is effective for women and men (Gonzalez et al., 2002) and for both blacks and whites (Ahluwalia, Harris, Catley, & Okuyemi, 2002). Bupropion SR minimizes weight gain associated with stopping smoking and reduces withdrawal symptoms (Hurt et al., 1997). Multivariate predictors of successful end-of-treatment outcomes include fewer cigarettes per day, longest duration quit in the past, and male gender (Dale et al., 2001).

While bupropion SR may lower seizure thresholds and cause hypersensitivity reaction (Ferry & Johnston, 2003), clinical studies and 32 million patient exposures (9 million for smoking) show that it is generally well tolerated. The most common adverse event in clinical trials or clinical practice is insomnia, which can also be a symptom of nicotine withdrawal. Tonstad and colleagues (2003) showed that bupropion SR was efficacious and safe for use with patients with cardiovascular disease. One-year continuous abstinence rates for bupropion SR were more than double the rates obtained with placebo (22 vs. 9%).

Bupropion SR may be safely combined with NRT to enhance 12-month quit rates (Gold, Rubey, & Harvey, 2002; Jorenby et al., 1999), although support for this strategy is weak. In one study, weight gain following the combination treatment was significantly less than with bupropion SR alone, although the difference in 12-month quit rates (30.3 vs. 35.5%) did not achieve statistical significance (Jorenby et al., 1999). In a study involving primary care smoking cessation clinics (Gold et al., 2002), the 6-month self-reported abstinence rate for nicotine patch alone was 14.8%, for bupropion SR alone, 27.7%, and for patch plus bupropion SR, 34.4%. Quit rates for both forms of bupropion SR treatments were significantly superior to patch treatment, although they were not significantly different from one another.

Hays and colleagues (2001) studied the efficacy of bupropion SR for prevention of smoking relapse. Participants (n = 784 healthy community volunteers) received open-label bupropion SR, 300 mg, for 7 weeks. Participants who were abstinent throughout week 7 of open-label treatment were randomly assigned to placebo or bupropion SR, 300 mg, for 45 weeks, and were subsequently followed for an additional year after the conclusion of the medication phase.

At the end of initial treatment, 58.8% of the participants were abstinent. The point prevalence smoking abstinence rates were significantly higher in the bupropion SR group than in the placebo group at weeks 52 (55.1 vs. 42.3%) and 78 (47.7 vs. 37.7%). The two groups did not differ at the final week of follow-up (week 104) (41.4 vs. 40.0%). The continuous abstinence rate was higher in the bupropion SR group than in the placebo group at study week 24 (17 weeks after randomization) (52.3 vs. 42.3%), but did not differ between groups after week 24. The median time to relapse was significantly greater for bupropion SR recipients than for placebo recipients (156 vs. 65 days), and weight gain was significantly less in the bupropion SR group at study weeks 52 (3.8 vs. 5.6 kg) and 104 (4.1 vs. 5.4 kg). Predictors of successful relapse prevention (in addition to assignment to bupropion SR treatment) were lower baseline smoking rates, a Fagerstrom Tolerance Questionnaire score < 6, and initiation of smoking at an older age (Hurt et al., 2002).

Hurt and colleagues (2003) studied the efficacy of bupropion SR (1) for preventing relapse in adult smokers who quit smoking with transdermal nicotine patch therapy and (2) for quitting smoking in smokers who failed to quit on the patch. At completion of nicotine patch therapy, nonsmoking participants were assigned to bupropion SR or placebo for 6 months (relapse prevention), and smoking participants were assigned to bupropion SR or placebo for 8 weeks of treatment. Of 578 subjects, 31% were abstinent at the end of nicotine patch therapy. Of those not smoking at the end of initial patch treatment, 28 and 25% were not smoking at 6 months (end of medication phase) for bupropion SR and placebo, respectively. For those still smoking at the end of nicotine patch therapy, 3.1 and 0.0% stopped smoking with bupropion SR and placebo, respectively. Hurt and colleagues concluded that bupropion SR neither reduced relapse to smoking in smokers who stopped smoking with the nicotine patch nor initiated abstinence among smokers who failed to stop smoking on the patch.

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