By John R. Hughes
INTRODUCTION
The purpose of this chapter is to update a prior review on the efficacy of combining behavioral therapy and nicotine replacement for smoking cessation (Hughes 1991).
Specifically, this chapter will review five areas: (1) how the current zeitgeist for smoking research and treatment differs from that of traditional drug dependence, (2) major methodological issues in assessing combined psychological and pharmacological treatments, (3) efficacy of combined behavioral and nicotine replacement for smoking cessation, (4) possible behavioral mechanisms for the improved efficacy of combined treatments, and (5) the importance of nonefficacy outcomes in assessing combined therapy.
(Note that the term behavioral treatments will be used in this chapter to encompass true structured behavioral treatments and treatments that have behavioral elements; e.g., most group therapies for smoking cessation include both behavioral and supportive therapy elements. Also, the term “drug abuse” will refer to nonnicotine, nonalcohol drug dependence or abuse.)
RESEARCH AND TREATMENT TRADITIONS OF NICOTINE VERSUS OTHER DRUG DEPENDENCIES
A brief history of research on and treatment of smoking can help understand why its traditions differ so much from those of other drugs of abuse (Lichtenstein and Glasgow 1992; Shiffman 1993). Early research on smoking treatment was limited to a few studies of various medications and studies of group education sessions.
In the 1960s, psychologists successfully developed behavioral treatments such as aversive conditioning, contingency contracting, rapid smoking, self-monitoring, stimulus control, and relapse prevention (Shiffman 1993). Many studies showed these techniques increased abstinence rates from 20 to 40 percent. (All abstinence rates quoted in this chapter are for 1-year followup unless otherwise noted.)
Despite this success, many became disenchanted with behavior therapy because of the large financial and labor costs it would take to offer behavior therapy to all 50 million smokers in the United States alone (Chapman 1985). In addition, among smokers trying to stop, less than 7 percent have been willing to attend behavior therapy (Hughes 1993a).
Thus, research focused next on briefer interventions such as self-help materials and physician advice. These showed modest effects; i.e., 5 to 15 percent of those treated abstained (Lichtenstein and Glasgow 1992). The utility of these brief interventions was questioned because so many smokers were stopping on their own due to the social and public health pressure in the 1980s.
At this same time, a general recognition of smoking as a drug dependence disorder became codified (American Psychiatric Association 1987; U.S. Department of Health and Human Services 1988), and a belief arose that those who were not quitting despite the intense social pressure were the more nicotine-dependent smokers (Coambs et al. 1989, pp. 337-348; Hughes 1993a). In 1984, nicotine polacrilex (nicotine gum) was marketed in the United States as the first proven antismoking medication followed soon after by transdermal nicotine (nicotine patch) (Hughes, in press).
Because of the huge pool of smokers, these products were financial successes, and pharmaceutical companies became very interested in antismoking medications. In contrast, research in and treatment of alcohol and drug dependence in the last 20 years has differed from smoking in several aspects (table 1).
For example, in the United States, alcoholism treatment has been dominated by the disease model and 12-step traditions (Miller and Hester 1986, pp. 121-174). Interestingly, several behavioral interventions, brief interventions (e.g., bibliotherapy and physician advice), and some pharmacotherapies have been shown to improve outcomes, but these validated treatments have not been integrated into mainstream alcoholism therapy (Miller and Hester 1986, pp. 121-174).
In summary, smoking treatment has been dominated by the necessity of clinical research demonstrating efficacy and by concern over cost-efficacy, whereas alcohol treatment has been dominated by allegiance to certain models of etiology and treatment. One other comment about smoking versus alcohol and drug abuse research bears mentioning. Those who do research in alcohol and drug abuse rarely cite findings or methodologies of research in smoking and vice versa.
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TABLE 1. Differences in emphusis in research on and treatment of nicotine, alcohol, and drug dependencies. [See source article.]
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This suggests researchers in one area are either unaware of findings in another or do not believe these findings are relevant. Those who do research in alcohol and drug abuse can learn about relapse curves, sophisticated data analyses, public health concerns, cost-efficacy, and so forth by reading the smoking literature.
Conversely, those who do research in smoking can learn about assessing functional status, psychiatric co-morbidity, improving treatment retention, and so forth, by reading the alcohol and drug abuse literature.
EFFICACY OF NICOTINE REPLACEMENT IN THE ABSENCE OF BEHAVIOR THERAPY
Traditionally, an adjunctive psychological treatment has been thought to be essential for pharmacotherapy for drug abuse to be effective. However, many have hypothesized that since most smokers do not have as severe psychological problems as alcohol, cocaine, and heroin abusers, that perhaps pharmacotherapy in the absence of a psychological therapy would be effective in smokers (Hughes 1993a; Jarvis 1988, pp. 145-162).
Early conclusions by this author (Hughes 1986) and others (Lam et al. 1987) that nicotine polacrilex is only effective when given with behavior therapy appear to have been incorrect. Several recent meta-analyses have examined nicotine polacrilex and transdermal nicotine with and without behavioral therapy (Baillie et al. 1994; Cepeda-Benito 1993; Fiore et al. 1994a; Gourlay and McNeil 1990; Lam et al. 1987; Silagy et al. 1994; Tang et al. 1994) (table 2).
Before discussing the results of these metaanalyses, two points need to be made. First, methodological procedures such as subject selection and type of control group have a profound effect on the absolute abstinence rates; thus, the fairest comparative measure in these meta-analyses is the odds ratio; i.e., the relative increase in quitting with nicotine polacrilex over a placebo or no-drug comparison group.
Second, most studies did not adequately describe the contents of either the behavioral or pharmacological therapy; e.g., what behavioral techniques were used or how much medication was given for how long (Hughes 1991). The four meta-analyses of nicotine polacrilex without behavior therapy reported odds ratios favoring nicotine polacrilex of 1.4, 1.5, 1.8, and 2.1 (first column, table 2).
However, the absolute difference in quit rates with nicotine polacrilex is small; i.e., 0 percent to +7 percent (second column, table 2). In contrast, the three meta-analyses of the efficacy of
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TABLE 2. Meta-analysis of long-term quit rate with nicotine polacrilex (NP) or transdermal nicotine (TN) versus placebo with and without psychological therapy (PT).
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To summarize, in contrast to pharmacotherapies for alcohol and illicit drug abuse, pharmacotherapy for smoking cessation (especially transdermal nicotine) is effective even when given without a structured psychological therapy.
EFFICACY OF ADDING NICOTINE REPLACEMENT TO BEHAVIOR THERAPY
Four meta-analyses have presented data that can estimate the effect of adding nicotine polacrilex to behavior therapy (third column, table 2). In these four meta-analyses, the odds ratio for long-term abstinence with adding nicotine polacrilex were 1.4, 1.7, 2.1, and 2.7, and absolute quit rates increased from +7 percent to +15 percent.
Three meta-analyses have estimated the effect of adding transdermal nicotine to behavior therapy (next-to-last column, table 2). The reported odds ratios were 2.0, 2.4, and 3.4, and the increase in absolute quit rates was +10 percent and + 13 percent. Cross-study comparisons (as in table 2) are always risky.
However, one review examined several studies in which subjects were randomly assigned to receive or not receive behavior therapy and/or nicotine polacrilex (Hughes 1991). Thus, these were direct experimental tests of the efficacy of adding nicotine polacrilex. In fact, these factorial studies crossed the presence versus absence of pharmacotherapy with the presence versus absence of behavior therapy all within the same pool of subjects (figure 1).
The relative increase in cessation with adding nicotine polacrilex in these direct tests was 1.0, 1.3, 1.6, 1.7, 1.7, 1.8, and 2.5, with increases in cessation rates of 0 percent to +20 percent. Similar factorial studies with transdermal nicotine have not been reported. To summarize, adding nicotine gum or nicotine patch appears to double quit rates over those obtained with behavior therapy alone.
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FIGURE 1. Experimental design forfactorial trial of combining behavior therapy and drug therapy.
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EFFICACY OF ADDING BEHAVIOR THERAPY TO NICOTINE REPLACEMENT
The converse question is how much quit rates would improve if behavior therapy was added to nicotine replacement. In terms of cross-study comparisons, none of the meta-analyses directly examined the efficacy of adding behavior therapy. However, two meta-analyses reported pooled quit rates with and without behavior therapy.
Comparison of these rates indicates a +13 percent increase with adding behavior therapy to nicotine polacrilex (Silagy et al. 1994) and a +7 percent and +6 percent increase with adding behavior therapy to transdermal nicotine (Fiore et al. 1994a). In the previously mentioned review of direct tests (Hughes 1991), the odds ratios for adding behavioral therapy to nicotine polacrilex were 0.8, 1.0, 1.6, 1.7, 1.7, 1.8, and 2.5, and absolute increases in quit rates were 0 percent to +27 percent.
Since that review, one other study has reported data that, when recalculated, produces an odds ratio of 2.7 (Goldstein et al. 1989). In terms of direct tests of adding psychological therapy to transdermal nicotine, this author is aware of only one randomized study (Buchkremer et al. 1991).
That study examined adding training in relapse-coping strategies with and without booster sessions and found no increased efficacy with adding behavior therapy. One other article compared two studies of transdermal nicotine in which subjects received group behavioral therapy in one but little therapy in the other (Fiore et al. 1994b). Although subjects were not randomized to groups, they were recruited in a similar manner, the drug treatment was similar, and the outcomes were similarly defined.
Comparison of the results of these two studies indicates an odds ratio of 3.1 for adding behavior therapy to transdermal nicotine. To summarize, the bulk of the evidence suggests adding behavior therapy to nicotine replacement approximately doubles quit rates over using nicotine replacement alone.
COMBINED THERAPY USING OTHER THERAPIES
The only other smoking cessation medication with a substantial database is clonidine. One meta-analysis reported an odds ratio for adding clonidine to behavior therapy of 4.2 (Covey and Glassman 1991). No data were available for adding behavior therapy to clonidine.
Although this result suggests clonidine is a very effective drug at potentiating behavior therapy, many of the studies reviewed in this meta-analysis had only short-term outcomes and were published in abstract forms (Hughes, in press).
As importantly, more recent articles have not replicated these effects (Glassman et al. 1993; Gourlay et al. 1994; Prochazka et al. 1992). One other study done several years ago examined combining a nonnicotine pharmacological treatment and psychological treatments (Schwartz and Dubitsky 1967, 1968).
This study was essentially a 3x3 factorial contrasting tranquilizers, placebo, and no-drug conditions with group therapy, individual therapy, and no-contact conditions. The psychological therapies were effective but the tranquilizers were not; thus, combined therapy was not any better than group or individual therapy alone.
One other study examined adding different types of psychological therapies (Hajek et al. 1985). Adding traditional group therapy to nicotine polacrilex improved outcome with nicotine polacrilex more than adding didactic, therapist-oriented group therapy (28 percent versus 17 percent). Replications of this finding have yet to be published.
BEHAVIORAL MECHANISMS TO EXPLAIN INTERACTIONS OF BEHAVIOR AND PHARMACOLOGICAL TREATMENTS
Behavioral Mechanisms to Explain Negative Interactions
Attribution theory (Davison and Valin 1969) hypothesizes that if smokers attribute their success to medications, then without medication they should expect to relapse. State-dependent learning (Whitehead and Blackwell 1979, pp. 157-189) hypothesizes that relapse-prevention skills learned while on medication will not be remembered when smokers are off medication and, thus, smokers will relapse after stopping medications.
In contrast to these theories, there is no evidence that relapse rates are greater after recommended or forced cessation of nicotine gum than during the comparable period for no-drug or placebo groups (Fiore et al. 1994a; Hughes 1993a; Sachs et al. 1994; Silagy et al. 1994).
COMPLEMENTARY EFFECTS ACROSS MEDIATING VARIABLES
One description of why stopping smoking can be so difficult is that it requires trying to make major behavioral and environmental changes while at the same time suffering from withdrawal symptoms of difficulty concentrating, irritability, insomnia, etc.
Thus, the positive effect of combined therapy could be because behavior therapy improves behavioral skills and nicotine replacement improves withdrawal. Interestingly, although nicotine replacement has been shown to decrease withdrawal (Hughes et al. 1990, pp. 317-398), whether this is the mechanism of its efficacy is suspect, because, surprisingly, the severity of withdrawal is only minimally related to the ability to abstain (Hughes and Hatsukami 1992; West, in press).
Similarly, whether behavior treatments actually change behaviors that are linked to the ability to abstain is (surprisingly) unknown (Payne et al. 1990).
COMPLEMENTARY EFFECTS ACROSS TIME
A related explanation for the efficacy of combined therapy is that nicotine replacement helps smokers stop in the first few weeks (when withdrawal is at its worst), and then behavioral therapy kicks in to help smokers stay stopped (since it may take a few weeks to learn the behavioral skills).
If this were true then in a factorial experiment one would expect the behavior-therapy-only group to have higher relapse initially but lower relapse later; the pharmacotherapy-only group to have lower relapse initially and greater relapse later; the untreated control group to have high relapse both early and late; and the combined treatment to have low relapse both early and late (figure 2).
One study did report less later relapse with behavior therapy (Goldstein et al. 1989). However, the expected pattern illustrated in figure 2 was not seen among the seven factorial studies with nicotine polacrilex (Hughes 1991); e.g., the nicotine polacrilex only group did not have high relapse rates after stopping nicotine polacrilex and the behavior therapy groups did not have less relapse between 3- and 12-month followup.
Also, the pattern of relapse in studies of nicotine patches without behavior therapy is similar to that of studies of nicotine patches with behavior therapy (Fiore et al. 1994a; Sachs et al. 1994; Silagy et al. 1994).
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FIGURE 2. Expected outcome if behavior therapy and pharmacotherapy worked at different times.
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COMPLEMENTARY EFFECTS ACROSS SUBJECTS
Another related explanation for increased quit rates with combined therapy is that behavior therapy and pharmacological therapy are helping two different groups of smokers. The large majority of studies have found that nicotine polacrilex is especially helpful to the more dependent smoker (Fagerstrom and Schneider 1989); however, for unknown reasons, it is not a robust predictor of benefit from transdermal nicotine (Fiore et al. 1994a; Hughes 1993a).
In addition, predictors of benefit from behavior treatments for smoking have not been identified (Fiore et al. 1994a; Hughes 1993a). Finally, the subgroups of responders to behavior and to psychological therapy may not be orthogonal; e.g., dependent smokers may also especially need behavior therapy and smokers who do not need pharmacotherapy may not need behavior therapy as well.
ONE THERAPY INCREASES COMPLIANCE WITH THE OTHER
Pharmacotherapy may decrease distracting symptoms of irritability, difficulty concentrating, and so forth, such that smokers are more able to comply with behavioral skills training. Conversely, behavior therapy may provide increased motivation, which translates to improved compliance with the pharmacotherapy. Unfortunately, few studies reported compliance across groups.
Two studies did report greater attendance at behavior therapy in groups that also received nicotine gum versus groups that did not receive gum, but one study reported similar use of gum in behavior therapy and no therapy groups (Hughes 1991). No studies reported attendance at behavior therapy as a function of drug group (Hughes 1991).
NONEFFICACY OUTCOMES
Efficacy (i.e., the increase in abstinence rates in a given study) is but one measure of treatment utility (Hollon and Beck 1987, pp. 437-490). Other measures are acceptability, availability, cost-efficacy, side-effect profile, and universality. The acceptability of behavior therapy for smoking cessation appears very poor, as less than 7 percent of smokers will attend free psychological therapy (Hughes 1993a). This may be due to poor availability (see below), nonreimbursement, or the general view that although talking therapy is often needed to overcome alcohol problems, this is not true for smoking.
The acceptability of pharmacotherapy; e.g., how often smokers fill physician-initiated prescriptions for nicotine replacement, is unknown. Psychiatrists often use pharmacotherapy initially to engage a patient in treatment and then turn to psychotherapy (Hughes and Pierattini 1992, pp. 97-126). Whether combining pharmacological and behavior treatments for smoking would make either treatment more acceptable is unknown.
The availability of psychological therapy for smoking cessation often is very poor. The most widely available treatments are those by public organizations such as the American Cancer Society, the American Heart Association, the American Lung Association, the Seventh-Day Adventists, or hospital/clinic programs.
Often these are not available in rural areas, and even in urban areas programs often occur only 2 or 3 times a year. Thus, to avail themselves of this treatment, many smokers would have to wait for long periods and drive many miles to attend the treatments. The availability of pharmacotherapy may appear high considering the large number of prescriptions that are filled.
However, surprisingly few primary care physicians prescribe nicotine replacement appropriately (Cummings et al. 1988; U.S. Department of Health and Human Services 1988), and specialists in smoking cessation are not likely to arise given the lack of reimbursement from health insurance.
Thus, the availability of adequate pharmacotherapy also appears limited. In terms of combined therapy, many withdrawal clinics either ignore or discourage use of pharmacological treatments (Hughes 1986, pp. 141-147), and many physicians do not refer to behavioral treatments (Cummings et al. 1988; U.S. Department of Health and Human Services 1988); thus, combined treatment is probably even less available to the large majority of smokers.
The cost-efficacy of brief treatments for smoking cessation is so much greater than that of all other medical interventions that it has been termed the gold standard for comparison (Tsevat 1992). The cost-efficacy of a course of nicotine replacement (Oster et al. 1986) and of intensive psychological therapy (Altman et al. 1987) also are quite good. The real question is whether adding a second treatment is cost-effective.
To examine this, some cost estimates from another article (Hughes et al. 1991) and the quit rates for the seven factorial studies of nicotine gum (Hughes 1991) to estimate cost per quitter were used (tables 3 and 4). Although adding a second therapy increases quit rates, it does not do so to the extent that it prevents an escalation in cost per quitter. There are two ways to interpret this result.
The first interpretation points to the increased cost per quitter with combined therapy and states that, until there are ways to determine who needs combined therapy, there should not be reimbursement for combined therapy for all comers.
The second interpretation points out the large economic benefits of smoking cessation; e.g., the cost-benefit of a 40- to 45-year-old moderate smoker stopping is $19,329 (Oster et al. 1984). Since these benefits greatly exceed the cost of the combined treatment, then combined treatment could be justified for all comers. Although the above two arguments are overly simplistic (Warner 1987), they do illustrate the dilemma about cost-efficacy that combined treatments face.
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TABLE 3. Percent abstinent in meta-analysis of seven factorial studies of nicotine gum.
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The side effects of nicotine replacement are well known and are benign (Hughes 1993b); e.g., less than 5 percent of those on transdermal nicotine drop out due to side effects (Hughes and Glaser 1993).
Side effects from behavioral treatment have not been examined but are possible; e.g., a decreased probability of future quit attempts among those who fail. Universality refers to whether a treatment can help a large group of persons with a disorder or only a small group; thus, this notion is closely tied to the proposed behavioral mechanism of complementary effects across subjects; i.e., more smokers are more likely to find something of benefit in a combined therapy than in a single therapy. As stated above, whether or not this is true for combined treatment of smoking is unclear.
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TABLE 4. Median cost per quitter across seven factorial studies of nicotine gum.
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CONCLUDING COMMENTS
The available data suggest combined behavioral and pharmacological therapy substantially increases smoking cessation over behavior therapy alone and over pharmacological therapy alone. However, there are many gaps in knowledge of the issue; e.g., how much does combined therapy increase outcome with transdermal nicotine and how does combined therapy increase quit rates?
In this era of concern over health care costs, perhaps the more important issues are the cost-efficacy of combined therapy and the specification of which smokers need combined therapy and which can do well with behavioral therapy alone or with pharmacological therapy alone.
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AUTHOR
John R. Hughes Human Behavioral Pharmacology Laboratory Department of Psychiatry University of Vermont 38 Fletcher Place Burlington, VT 05401-1419
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From NIDA Monograph 150 - Integrating Behavioral Therapies With Medications in the Treatment of Drug Dependence