The goal of this study was to evaluate an extended cigarette smoking treatment program for one group of chronic, heavy smokers: adults 50 years of age and older. The study was guided by the concept of tobacco dependence as an addiction with a chronic, relapsing course [1
]. Most smokers try to quit many times. Generally, these quit attempts fail and relapse is the norm [3
]. For most addictions, the recognition that addictive disorders are chronic and relapsing has led to services that include treatment of extended duration, follow-up support and encouragement of treatment re-entry. This does not describe the usual provision of services to cigarette smokers. For the most part, intervention models have been either inexpensive or time-limited, and have used brief courses of treatment. There are three corollaries to a chronic disorder model: first, pharmacological treatments should be used if possible, at least when physical symptoms predominate. Secondly, smoking comes to serve diverse functions for the smoker—for example, weight and mood regulation—and modalities to overcome the multiple deficits presented by loss of these functions need to be provided. Thirdly, independent of the content of the intervention, the model of tobacco dependence as a chronic disorder suggests that long-term treatment, perhaps even treatment re-occurring over a life-time, may be necessary.
Few interventions take into account the implications of this model. This failure may explain the low long-term cigarette abstinence rates we have come to expect for tobacco dependence treatment—usually 25–30% at 1 year, even with combined pharmacotherapy behavioral therapy [2
There are studies of extended treatments in the literature. An early study assessed the effects of extended combined nicotine replacement therapy (NRT) versus single modality NRT. Kornitzer et al.
] compared active patch plus active nicotine gum, active patch plus placebo gum and placebo patch plus placebo gum over 6 months, and found significant differences favoring active patch plus active gum. More recently, four studies addressed the efficacy of extended bupropion administration, with mixed results. Hays et al.
treated participants for 7 weeks with open-label bupropion, then assigned randomly the cigarette-abstinent participants only (59% of the initial sample) to active or placebo bupropion for 45 weeks. Cigarette abstinence was significantly higher in the bupropion group than in the placebo group after 1 year of drug therapy but the conditions did not differ at 2 years [7
]. In a second study by this group, smokers were treated with nicotine patches calibrated to their level of cigarette intake. Cigarette-abstinent participants were assigned randomly to either active or placebo bupropion for 6 months. Abstinence rates did not differ between conditions [8
]. Cox et al.
] randomized abstinent smokers who had been treated with bupropion for 7 weeks to either continued bupropion for the remainder of 1 year or to placebo. Bupropion produced higher cigarette abstinence at the end of medication treatment when compared to placebo, but no differences at 1 year follow-up. Killen et al.
] treated smokers for 12 weeks with open-label bupropion, nicotine patch and weekly relapse prevention training. All participants independent of smoking status were then offered four relapse prevention sessions, and continued on either active or placebo bupropion for an additional 14 weeks. There were no differences in abstinence rates between conditions at 1 year. Using nortriptyline, we completed a study in which smokers were assigned to one of four treatment conditions in a 2 × 2 (nortriptyline versus placebo by brief treatment versus extended treatment) design. Participants in extended treatment continued taking drug or placebo and received monthly individual counseling sessions to week 52, with telephone calls between sessions. At week 52 we found a 50% cigarette abstinence rate for smokers given extended nortriptyline plus counseling over a 1 year period, and a 42% cigarette abstinence rate at 1 year for those receiving counseling plus placebo [11
], both of which exceeded the effects of short-term treatment. Studies assessing the effects of extended varenicline administration appear to indicate that this drug may enhance abstinence. Tonstad et al.
] randomized abstinent smokers who had been treated with 12 weeks of varenicline to either continued varenicline treatment or to placebo for an additional 12 weeks. Continuous cigarette abstinence rates were higher for the varenicline group than the placebo group for weeks 13–24 and 13–52. Williams et al.
] administered either varenicline or placebo over a 1-year period, and found that varenicline was superior to placebo at both 12 and 52 weeks. One study assessed the effects of cognitive behavioral therapy (CBT) in promoting long-term abstinence [14
]. Participants received bupropion, nicotine patch and CBT for 8 weeks, and were then assigned randomly to receive either 12 weeks of CBT plus voice-mail monitoring and telephone counseling, or telephone-based general support. These investigators reported significant differences at 20 weeks in favor of the CBT condition, but differences at 52 weeks were not significant. A predicted gender × treatment interaction was not found although history of depression was a treatment moderator, with individuals with a positive history showing a better response when assigned to the less intensive condition.
In summary, the existing data present a mixed picture with respect to the efficacy of most extended treatments. There are few follow-ups after the end of treatment, and in those that have been completed there was only modest evidence of maintenance of treatment effects. It is difficult to interpret cigarette abstinence rates in most studies, because only cigarette-abstinent smokers continued into the extended treatment portion of the study.
In the present study, all participants continued into the extended treatment phase of the study, thus allowing comparisons to the cigarette abstinence rates reported in most of the literature. The intervention was directed specifically at components of relapse and a follow-up was conducted 1 year after the end of extended treatment. The CBT-based intervention addressed the five areas that the 2000 Practice Guidelines indicated were important in relapse [2
We selected smokers 50 years of age and older as participants for five reasons. First, surveys [15
] and descriptive data from randomized controlled trials conducted in the mid-1990s suggested that older smokers are long-term, heavy smokers who are dependent on nicotine and who are motivated to quit [15
]. Secondly, older Americans are the fastest-growing population segment, and this growth will increase the sheer number of older smokers [20
]. Thirdly, smoking is a risk factor for seven of the 14 major causes of death in older people [21
]. Fourthly, even though both smokers and their physicians seem to assume that quitting smoking when older will have limited benefit, for this age group, as for other age groups, risks for heart disease, stroke and even lung cancer decline after quitting [22
]. Fifthly, there are few recent treatment studies of older smokers. There has not been a randomized control trial of tobacco dependence interventions for older smokers reported in the literature in the past 14 years. Age 50 was selected because it was the definition of ‘older smokers’ used by the 2000 Practice Guidelines [2
There were four experimental conditions: standard treatment (ST); extended NRT (E-NRT; extended cognitive–behavioral treatment alone (E-CBT); and extended cognitive behavioral treatment plus extended NRT combined (E-combined). The following hypotheses were proposed: (i) over weeks 24, 52, 64 and 104, the E-CBT condition, the E-combined condition and the E-NRT condition will produce higher point prevalence cigarette abstinence rates than the ST condition; (ii) over weeks 24, 52, 64 and 104, E-combined will have higher point prevalence cigarette abstinence rates than the remaining three conditions; (iii) while both men and women will have the highest point prevalent cigarette abstinence rates in the E-combined condition, the difference between this condition and the other three conditions will be greater for women than for men. This hypothesis, formulated before the publication of Killen et al.
’s 2008 paper [14
], was based on the frequently voiced supposition that women are helped more by social support than are men while quitting smoking [1