DESCRIPTION: (Applicant's Description)
Tobacco use remains the leading preventable cause of premature death in the
U.S., and this public health problem will remain so if advances in the
treatment of nicotine dependence do not occur. While the approved
medications for smoking cessation to date are those that provide nicotine
replacement, recent studies evaluating the effects of novel non-nicotine
medications suggest that significant improvements in cessation rates may be
One of the most promising non-nicotine medications is bupropion (Zyban).
Bupropion has been available as an antidepressant that increases dopamine
availability and thus elevates mood, and will be FDA approved as a smoking
cessation medication. Furthermore, it has been investigated as a medication
for the treatment of attention deficit/hyperactivity disorder in youth.
Because the efficacy of bupropion for adult smoking cessation is greater
than nicotine replacement, and because the safety of bupropion has been
shown in youth, it is the clear choice for investigation as a pharmacologic
treatment for youth smoking cessation. Since the optimal dose for smoking
cessation has not been assessed in youth, a dose ranging study to evaluate
the safety and efficacy of bupropion for smoking cessation in youth is
proposed. The proposed study is a randomized, double-blind,
placebo-controlled clinical trial designed to assess (1) which bupropion
dose, if any, increases abstinence rates over placebo, and (2) which
factors, such as medication adherence, nicotine dependence, and motivation
to quit, affect treatment outcome.
There are a number of potential benefits from the proposed study. The
results of the proposed study could lead to a better understanding of how to
use a pharmacologic treatment for youth smoking cessation. Initiation of
tobacco use is largely a sociocultural process, nicotine dependence is a
medical condition whose treatment is optimized when the full armamentarium
of medical care is provided. The proposed study will follow Agency for
Health Care Policy and Research guidelines for smoking cessation, including
a medical model approach that combines behavioral and pharmacologic
intervention within a health care environment. While many studies have
evaluated cessation methods for adults, there remains a dearth of research
evaluating methods for enhancing youth smoking cessation. With so little
research upon which to expand, the proposed study could lead to important
new understandings regarding the process and mechanisms of youth smoking
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