Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

Phase 3

Completed

Conditions: Nicotine Dependence
Major Depressive Disorder
Depression

Interventions: Drug: Fluoxetine
Drug: Dextrose

Registration Number: NCT00578669

Lead Sponsor: Butler Hospital

Brief Summary: The primary purpose of this study is to determine whether, among smokers with elevated depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun 8 weeks prior to and extended throughout standard smoking cessation treatment with transdermal nicotine patch (ST-TNP) will result in superior short-and long-term smoking cessation outcomes compared to sequential pharmacotherapy with placebo medication combined with ST-TNP. The secondary aim of the study is to test the hypothesis that, among smokers with elevated depressive symptoms, sequential treatment with fluoxetine will result in lower levels of depressive symptoms and negative mood and higher levels of positive mood immediately prior to and throughout the course of smoking cessation treatment relative to the placebo condition.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 206

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fluoxetine	Sequential antidepressant pharmacotherapy with (20mg) fluoxetine, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
2	Dextrose	Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Primary Outcome Measures

Name	Time	Method
Number of Participants Achieving Smoking Abstinence	One year	7-day point prevalence abstinence

Secondary Outcome Measures

Name	Time	Method
Self-reported Depressive Symptoms	One year	Self-reported depressive symptoms based on the Center for Epidemiologic Studies-Depression (CES-D) scale. CES-D consists of 20 items, with total scores on the scale ranging from 0 - 60. Higher scores are indicative of greater levels of depressive symptoms.