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.
