Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

Cigarette smoking is the leading cause of death and disability in the United States, accounting for over 430,000 deaths in this country every year. The selection hypothesis of smoking prevalence argues that smokers who are unable to quit successfully are likely to possess risk factors or characteristics that make it difficult to quit, such as nicotine dependence and psychiatric comorbidity. As such, significant strides in helping "today's" smokers quit will ultimately be found in the ability to develop specialized treatments that target the particular needs of subgroups of smokers, especially those who are at higher risk for relapse. Depression is the psychiatric disorder most frequently associated with cigarette smoking in adults and strong associations have been demonstrated between cigarette smoking and both depressive disorders and depressive symptoms. In fact, a prospective analysis from the National Health and Nutrition Examination Survey showed that smokers with elevated depressive symptoms were 40% less likely than nondepressed smokers to have quit nine years later.

The development of an efficacious, specialized treatment of nicotine dependence for smokers with elevated depressive symptoms would address this need by providing physicians with an effective treatment alternative for the large number of smokers with depressive symptoms seen daily in clinical practice. This study examines the hypothesis that smokers with elevated depressive symptoms treated with fluoxetine 8 weeks prior to quitting and extended throughout 8 weeks of standard treatment with the nicotine patch post-quit will demonstrate superior cessation outcomes compared to placebo medication combined with standard treatment and the nicotine patch, administered with the identical treatment schedule. A secondary hypothesis is to examine whether reductions in depressive symptoms and negative mood and increases in positive mood will be greater for those in the sequential fluoxetine versus placebo condition.

Inclusion criteria

• Regular smoker for at least one year
• Currently smokes at least 10 cigarettes per day
• Elevated depressive symptoms
• Uses no other tobacco products

Exclusion criteria

• Current Axis I disorder, including Major Depressive Disorder
• Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
• Current use of psychotropic medication
• Use of antidepressant medication within past 6 months
• Current suicidal risk
• History of significant medical illness, such as cardiovascular disease, neurological, gastrointestinal, or other systemic illness
• Pregnancy or breast feeding
• Use of nicotine replacement therapy or of any medication for smoking cessation not provided by the researchers during the quit attempt