The present study is one of the first to assess the efficacy of bupropion SR for relapse prevention among a group of nondepressed smokers with alcohol dependence in sustained full remission. The major finding is that bupropion SR did not reduce or delay relapse to smoking in this population. Tailored nicotine patch therapy did result in excellent end-of-treatment abstinence (Hurt et al., 2005
), but this did not translate into higher rates of prolonged smoking abstinence among the bupropion-treated subjects. These results are in contrast to a previous study of bupropion SR used for smoking relapse prevention (Hays et al., 2001
) but are consistent with a study of tailored NRT followed by bupropion for smoking relapse prevention in a multicenter trial, both conducted among general population samples of smokers (Hurt et al., 2003
). Our findings are also consistent with a recent meta-analysis that concluded that smokers with a history of alcohol dependence respond equally well to tobacco dependence treatment but are less likely to achieve permanent abstinence during their lifetime (Hughes & Kalman, 2006
Our approach using tailored nicotine patch therapy plus bupropion SR was thought to be potentially beneficial for recovering alcoholics because it is consistent with a method of alcohol dependence treatment and relapse prevention using medications such as naltrexone or acamprosate to promote cessation and support long-term abstinence. However, our study does not support the use of bupropion SR for smoking relapse prevention among smokers in stable recovery from alcohol problems.
Our findings add to the literature on the pharmacological treatment of tobacco dependence among recovering alcoholics. We used tailored nicotine patch therapy as the initial treatment to achieve smoking abstinence, whereas a previously reported study (Hays et al., 2001
) used open-label bupropion as the initial treatment. Using the same drug for initial treatment of tobacco dependence and continuing it for relapse prevention may be the preferred approach. Additional studies in the population of recovering alcoholic smokers will be necessary to test this approach.
The strengths of our study include its randomized, double-blind design in a large number of subjects in stable recovery from alcohol dependence. Our interventions and assessments were comprehensive and detailed. Our study subjects were mostly male and White and were less likely than expected to endorse a history of major depression. These factors may limit the generalizability of our findings.
We found no increase in depressive symptoms over time or between the bupropion SR and placebo groups. Depression is common among recovering alcoholics, and depressive symptoms may be associated with an increased risk of relapse (Strowig, 2000
). In contrast, we found evidence of increased nicotine withdrawal symptoms during the weeks shortly after randomization. It is difficult to ascribe these increases in nicotine withdrawal scores to the discontinuation of nicotine patch since the increases occurred at 2–3 weeks following the end of nicotine patch therapy. Regardless, most smoking relapse activity occurred after Weeks 10–11, the period when nicotine withdrawal symptom scores increased over baseline levels. Thus, neither depressive symptoms nor possible nicotine withdrawal appear to explain the smoking relapse activity we observed among all randomized subjects.
A previous study of bupropion SR for smoking relapse prevention found a significant effect for reducing weight gain in bupropion-treated subjects (Hays et al., 2001
). The present study found a modest effect for reduced weight gain among the bupropion group in the first weeks of randomized therapy that waned thereafter. Although the bupropion-treated subjects experienced less actual weight gain, both in the overall analysis and among subjects who were continuously abstinent from smoking (greater than 1 kg less weight gain among smoking abstinent subjects on bupropion compared with those on placebo), these differences were not significant due to the small numbers of participants in each group. The effects of bupropion on ameliorating postcessation weight gain may not be as robust in this select population of smokers as one might expect among the general population.
In summary, we found that bupropion SR compared with placebo was not effective for smoking relapse prevention when provided following tailored NRT in a group of smokers in stable recovery from alcohol dependence. Bupropion SR was well tolerated, however. In addition, relapse to alcohol or drug use during smoking cessation occurred in a small minority of participants and was similar to the rate found in a prior study of recovering alcoholic smokers treated for tobacco dependence (Martin et al., 1997
). Additional research in smokers with a history of alcohol dependence is warranted to determine the most effective pharmacological and behavioral approaches to treatment for these smokers who are at high risk of tobacco-caused morbidity and mortality.