DESCRIPTION (investigator's abstract): Four hundred adult smokers will be
enrolled in the study. The primary goal is to compare 2 strategies designed to
promote longer-term maintenance of smoking cessation. Each strategy will
include an acute treatment phase and a maintenance treatment phase. All smokers
will receive the same "Acute Phase Treatment." In this acute phase, all smokers
will receive treatment for nicotine dependence that combines nicotine patch
(21mg), bupropion (300mg), and relapse prevention training (RPT). During the
acute phase, nicotine patch will be provided for a total of 8 weeks and
bupropion and RPT will be provided for a total of 9 weeks. Following the acute
treatment phase, participants will enter a "Maintenance Treatment Phase."
During maintenance treatment, half of the participants (n=200) will receive an
additional 16 weeks of therapy with bupropion. The other half (n=200) will
receive matching placebo. Primary hypothesis: Participants who receive
bupropion during the maintenance treatment phase will have a higher abstinence
rate at l2mo follow-up than participants assigned to receive matching placebo.
Abstinence will be defined as a report of non-smoking (not even a puff) for 7
consecutive days prior to contact plus a saliva cotinine level below 20 ng/ml.
With 200 participants per cell, we will have, in general, 80 percent power at a
2-tailed alpha of .05 to detect a difference in abstinence rates of at least 15
percent over a large range of success probabilities. Secondary objectives: we
propose to genotype all subjects for polymorphisms at loci hypothesized to
affect nicotine dependence and/or bupropion efficacy. These include CYP2D6, the
serotonin transporter, the dopamine transporter, dopamine D2 receptor, and the
dopamine D4 receptor. Analyses will examine whether polymorphisms at these loci
moderate response to treatment. The proposed study will address several
important gaps in our knowledge. First, our proposed study would be perhaps the
first to evaluate the efficacy of an antidepressant medication as maintenance
therapy in the treatment of nicotine dependence. Second, this study would be
among the first to examine the efficacy of a treatment for nicotine dependence
combining nicotine replacement and antidepressant medication. Third, to our
knowledge this may be the first prospective trial of smoking cessation
techniques in which genetic data are included as predictors of outcome. In
general, this study will provide important practical information to the medical
and health communities concerning the utility of longer-term therapy with
antidepressant medication for smoking cessation and will advance our knowledge
of the underlying relationship of nicotine addiction and depression.
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