EFFICACY OF CLONIDINE AS AN AID TO SMOKING CESSATION

Pharmacologic interventions, such as nicotine gum, are valuable adjunct
to clinic based treatments for smoking cessation. Recently, research has
demonstrated that clonidine, a centrally-acting antihypertensive agent,
may attenuate acute tobacco withdrawal symptoms and craving for
cigarettes. Thus, clonidine may also prove to be a powerful
pharmacologic adjunct to smoking cessation treatment. To date, however,
no studies have investigated clonidine's effects on withdrawal symptoms
over periods longer than one day. Moreover, its' effects on short and
long-term abstinence from smoking remain unexplored. The proposed study
seeks to investigate clonidine's effects on withdrawal symptoms and
abstinence during the first two weeks after quitting smoking, and it's
effect on abstinence 3, 6, and 12 months post treatment. Two hundred thirty-six heavy smokers, referred by primary care
phvsicians, will be ,assigned randomly in double-blind fashion to
receive clonidine, in a transdernal form, ior a placebo. All subjects
will be also treated using a combination of brief individua counseling
and behavioral self-help methods. Initially, subjects will receive
counseling and the American Lung Association's self-help materials help
to prepare them for quitting. Subjects will be instructed to apply a
clonidine or placebo transdermal ,patch the day they quit smoking and to
leave it in place for 1 week thereafter.
Withdrawal symptoms, and side effects will be measured for two weeks
after quitting. Biochemically-verified abstinence will be assessed two
weeks after quitting and 3, 6, and l2 months after the end of treatment.
Patients will be drawn from a primary care medical population, and a
brief counselingself-help approach to treatment will be utilized, to
permit generalization of the methods and results to medical populations
and settings. It is hypothesized that clonidine,when compared to a
placebcx will decrease '.withdrawal symptoms and increase initial quit
rates, and enhance 3, 6, and 12 month ismoking cessation outcomes. If
proven effective, the combination of clonidine and brie .counseling
self-help smoking cessation treatment is likely to becote an important
tool .in the effort to reduce the health, social, and economic burdens
of smoking-related cardiovascular diseases.